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Children deserve to be treated with appropriate medicines based on robust assessments. Despite the introduction of new regulations, the availability of medicines for children is suboptimal because of the frequent lack of relevant clinical trials due to the difficulty of conducting such trials. Thus, the Transparency Committee (TC) of the French National Authority for Health, who oversees the assessment of medicinal products in France, set up a pediatric working group with two aims: (1) The first aim was to review all opinions on medicines for pediatric use. Out of 536 opinions delivered between 2020 and 2022, 181 (34 %) concerned medicines for pediatric use. Whereas oncology largely dominated the medicines for adults, medicines for infectious diseases, endocrinology/metabolism, neurology, and hematology mostly prevailed for children. (2) The second aim was to clarify the evaluation criteria assessed by the TC, namely, the clinical benefit (CB), the clinical added value (CAV), and the public health impact (PHI) for pediatric medicinal products. An important CB was given to 113 out of 161 (71 %) opinions on medicines for pediatric use when it concerned pathologies with a severe prognosis. The quality of the demonstration (e.g., double-blind randomized trial vs. placebo or another active medicine) played a major role in the CB level. Clinical pediatric studies were also consistently associated with higher CAV levels: levels I (major) to III (moderate) in 26 out of 42 (62 %) opinions, level IV (minor) and level V (no therapeutic progress) in 43 out of 84 (51 %) and 30 out of 43 (70 %) opinions granting a sufficient CB, respectively. Conversely, 22 out of 30 (73 %) dossiers based only on literature reviews were given a level V. The main criteria leading to the qualification of a medicine for pediatric use as providing a PHI included a significant change in the morbidity and mortality of the disease and an improvement in the care pathway. Assessments were mostly aligned on the adults in the case of subsequent extensions of indications to children. Lastly, new measures were taken aimed at shortening median delays in the assessment process in order to reduce off-label use of medicines in France. [ABSTRACT FROM AUTHOR]

Extracellular vesicles (EVs) hold great promise for clinical application as new diagnostic and therapeutic modalities. This paper describes major GMP-based upstream and downstream manufacturing processes for EV large-scale production, also focusing on post-processing technologies such as surface bioengineering and uploading studies to yield novel EV-based diagnostics and advanced therapy medicinal products. This paper also focuses on the quality, safety, and efficacy issues of the bioengineered EV drug candidates before first-in-human studies. Because clinical trials involving extracellular vesicles are on the global rise, this paper encompasses different clinical studies registered on clinical-trial register platforms, with varying levels of advancement, highlighting the growing interest in EV-related clinical programs. Navigating the regulatory affairs of EVs poses real challenges, and obtaining marketing authorization for EV-based medicines remains complex due to the lack of specific regulatory guidelines for such novel products. This paper discusses the state-of-the-art regulatory knowledge to date on EV-based diagnostics and medicinal products, highlighting further research and global regulatory needs for the safe and reliable implementation of bioengineered EVs as diagnostic and therapeutic tools in clinical settings. Post-marketing pharmacovigilance for EV-based medicinal products is also presented, mainly addressing such topics as risk assessment and risk management. [ABSTRACT FROM AUTHOR]

Many medicinal products are initially developed and tested in adults, and often, only a limited amount of data on their safety and efficacy in children exist. Consequently, paediatric healthcare providers sometimes need to make informed decisions about using medicinal products in children based on available fragmentary data. Ethical guidelines emphasise the importance of protecting children and ensuring they receive safe and effective medical treatments. Paediatric clinical trials should be conducted to provide evidence- based care with specific attention to minimise risks to children. This highlights the dilemma of finding a balance between protecting children and adolescents (and avoiding unnecessary clinical trials) and obtaining reliable, robust and justified data to treat them adequately and not in an off-label manner with unknown risks. For years, paediatricians maintained that children and adolescents are not treated based on up-to-date scientific knowledge and justification. The slogan "children are not small adults" summarised the concerns in a catch phrase. Different stakeholders have taken a variety of actions to address this concern. [ABSTRACT FROM AUTHOR]

Dendrobium brymerianum Rchb. f. is a species of orchid with pharmacological interest for its potential to inhibit the growth of human lung cancer cells. The identification of the Dendrobium species is a notable problem due to morphological similarities and the limitations of universal DNA barcodes. To overcome these difficulties, this study employed complete chloroplast (cp) genome sequences as useful resources for the identification of D. brymerianum. Based on Illumina sequencing, the complete cp genomes of five D. brymerianum individuals were assembled. These genomes were in the quadripartite structure, diverse in length between 151,832 and 152,189 bp, and comprised 126 genes. Moreover, significant differences were found in the Small Single-Copy (SSC) and Large Single-Copy (LSC) regions in comparison to the Inverted Repeat (IR) regions. This study recognized hotspot regions and simple sequence repeat (SSR) loci, providing valuable insights into genetic markers. The phylogenetic relationship of Dendrobium species was discovered, highlighting the need for more precise differentiation practices. To address this, ARMS-specific primers, mainly AAob1/AAob2, confirmed strong specificity, permitting the accurate identification of D. brymerianum from other species through ARMS-qPCR. Overall, this study of D. brymerianum chloroplast genomes has generated valuable data about sequence variations, phylogenetics, and mutation dynamics. These perceptions will be valuable in future research on population genetics, taxonomy, and species identification within the Dendrobium genus. [ABSTRACT FROM AUTHOR]

Many medicinal products are initially developed and tested in adults, and often, only a limited amount of data on their safety and efficacy in children exist. Consequently, paediatric healthcare providers sometimes need to make informed decisions about using medicinal products in children based on available fragmentary data. Ethical guidelines emphasise the importance of protecting children and ensuring they receive safe and effective medical treatments. Paediatric clinical trials should be conducted to provide evidence-based care with specific attention to minimise risks to children. This highlights the dilemma of finding a balance between protecting children and adolescents (and avoiding unnecessary clinical trials) and obtaining reliable, robust and justified data to treat them adequately and not in an off-label manner with unknown risks. For years, paediatricians maintained that children and adolescents are not treated based on up-to-date scientific knowledge and justification. The slogan “children are not small adults” summarised the concerns in a catch phrase. Different stakeholders have taken a variety of actions to address this concern.

Background. As the global burden of neurological diseases has been increasing, clinical trials have become more important. Yet, no systematic analysis of clinical trials of neurological medicinal products has been done in Europe and, specifically, in Lithuania. The aim of this study is to evaluate the tendencies of characteristics and registration dynamics of clinical trials of neurological medicines in Europe and Lithuania.Materials and methods. Analysis of data from the clinical trials register of the European Union drug regulatory authorities (EudraCT) has been performed. Applications of clinical trials of neurological medicines included in the register during the period between 2012–2021 have been reviewed. The following aspects have been evaluated: the phase of the trial, the sponsor status, the neurological condition (indication), the expected sample size of the trial, the trial design, and the number of member countries.Results. 2,242 clinical trials of neurological medicines have been registered in Europe during the period of 2012–2021, and they comprised 6.49% of all clinical trials registered in Europe. The annual registration rates did not change significantly during the period of 2012–2021 (R² = 0.039; p = 0.606). The majority of the trials (72.18%) were sponsored by commercial pharmaceutical companies. Most trials (31.73%) were registered as phase I trials. The majority of the trials (363 (17.20%)) were clinical trials for Alzheimer’s disease and other dementias. During the period of 2012–2021, there was a significant decrease in the annual registration rate of clinical trials for Alzheimer’s disease and other dementias (R² = 0.751, p = 0.001) and an increase of clinical trials for myoneural junction and muscle diseases and motor neuron disease (R² = 0.582, p = 0.010 and R² = 0.635, p = 0.006, accordingly). Commercial trials had a higher planned number of subjects (p = 0.014). Multiple member states participated in commercial trials more frequently (p < 0.001). Fifty-five clinical trials of neurological medicines were registered in Lithuania during the period of 2012–2021, and they comprised 8.08% of all clinical trials registered in Lithuania. The annual registration rate has decreased significantly (R² = 0.401, p = 0.049). Almost all trials in Lithuania (53 out of 55) were sponsored by commercial companies. The majority of trials (23 (42%)) were trials for demyelinating diseases of the CNS.Conclusions. The annual registration rates of trials of neurological medicines remain stable in Europe while decreasing in Lithuania. Commercial clinical trials have more participants, and are more commonly conducted in multiple member states.

Pharmaceutical companies frequently engage in drug advertising to connect with potential buyers. In the competitive pharmaceutical market, where patients are highly sensitive to various forms of advertising, manufacturers aim to reach a broad audience. This rapid dissemination of information in the advertising of medicinal products leads to some details being unverified and inaccurate, which emphasizes the critical importance of establishing and enforcing legislation. This paper aims to evaluate the current legislation for advertising of medicinal products in Republic of North Macedonia, as well as the regulations in European Union member states, namely Germany, Slovenia and Spain. The basic legal act that regulates the advertising of medicinal products in the European Union is Directive 2001/83/EC of the European Parliament and of the Council of Europe of 6 November 2001 on the Community code relating to medicinal products for human use such as amended by Directive 2004/27/EC of 31 March 2004. By reviewing relevant literature and conducting a comparative analysis of regulations in the Republic of North Macedonia and European Union, it can be concluded that the European Directive serves as a foundational framework. Each country has transposed the European Directive in domestic laws and regulatory guidelines with local adaptations and all Member States have therefore adopted further specific measures concerning the advertising of medicinal products. Depending on the member state, pharmaceutical promotion can be monitored and controlled by the government, by a national competent authority or not, this approach is called “self-regulation.Upon examining the regulatory structures in each specific country, there are five key components that must be implemented: development and adoption of national laws and regulations; implementation of the regulation, codes and other standards; monitoring the pharmaceutical promotion to ensure compliance with legal regulations; enforcement of the law through suitable sanctions to prevent violations; and evaluation of regulatory efficiency. Drawing parallels between the practices of established European member states and the regulatory framework of the Republic of North Macedonia, it becomes evident that there is an opportunity for the Republic of North Macedonia to leverage positive experiences from the European countries. By incorporating successful elements of European member states' regulations, the Republic of North Macedonia could enhance its own pharmaceutical regulatory environment. Based on this evaluation of established practices and experiences in European countries, direction will be provided for harmonizing and improving the regulatory framework for advertising od medicinal products in the Republic of North Macedonia. [ABSTRACT FROM AUTHOR]

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The presented article provides a systematic review of the pharmaceutical legislation (EU Pharmaceutical Package) - the current proposal of the European Commission for a new Directive, repealing and replacing Directives and modifying Regulations of the European Parliament and of the Council, incorporating the relevant parts of the Regulation concerning medicinal products for pediatrics, Regulation for orphan drugs and others, aiming at revision of the pharmaceutical legislation in the context of antimicrobial resistance and challenges facing the introduction of innovative antimicrobial medicines in Europe. It outlines a critical analysis on the impact of the changes in the context of introduction of innovative antimicrobial medicinal products with an emphasis on unsatisfied medical demands of the European population. The revision of the pharmaceutical legislation provides an argument to consider that the proposed Pharmaceutical Package could resolve some of the issues associated with the access to novel antibiotic medicines. It is necessary to find a consensus and a balance between, on the one hand, meeting the need for antibiotics for the citizens of the European Union and, on the other hand, providing timely access to generic medicines to meet the needs of the population. [ABSTRACT FROM AUTHOR]

The article presents the results of a comparative analysis of regulatory requirements for expertise of clinical trials documentation, submitted for regulatory authority and ethic committees' approval in EU member countries and Ukraine, outlining the main trends, considering the updated Regulation (EU) No 536/2014, which came into effect on January 31, 2023. Among the positive changes are simplification of safety reporting requirements, use of artificial intelligence in the process of clinical trials documentation examination for obtaining regulatory authority and ethic commission approval, introduction of a single portal for submitting materials for clinical trials, and functioning of database for the submission and review of initial Clinical Trial Application documents and obtaining authorization within the EU to facilitate the interaction between applicants and regulatory authority are highlighted. To harmonize Ukraine's regulatory requirements with EU legislation, it is advisable to use a single portal for data exchange and document submission for applicants in regards to clinical trials, regulatory authority and local ethics committees. This will expedite the examination process of clinical trial documentation and simplify the monitoring of document review progress. [ABSTRACT FROM AUTHOR]

The article is devoted to the issue of causing harm to pharmaceutical activity as an object of criminal law protection. As the author notes, the current legislation regulating the procedure for pharmaceutical activity contains certain guidelines for determining harm to the specified social values or its individual fragments. In the opinion of the author, characterizing the formation of harm "within" pharmaceutical activity as an object of criminal law protection and its consideration in the composition of criminal offenses, it is necessary to determine the types of actions that affect pharmaceutical activity and lead to its violation - formation in it or in certain types of damage to its individual "components". The author consistently proves that the aspects of influence on pharmaceutical activity, which give the committed act the properties of public danger, should be associated with various indicators of damage caused to pharmaceutical activity as an independent object of criminal law protection. [ABSTRACT FROM AUTHOR]

Medicinal products are a special type of goods due to their importance for human health and life, and their trade is generally under the scope of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. The preamble to this act states that the essential aim of the rules governing the production, distribution and use of medicinal products must be to safeguard public health. Hence, in the above-mentioned directive, the rules related to the authorisation of medicinal products for marketing and pharmacovigilance are very important. At the same time, it should be noted that parallel import of medicinal products as a form of trade in an EU Member State in connection with their authorisation for marketing in another Member State, although it has a long tradition, has not had a clear normative pattern, and has not been subject to the scope of Directive 2001/83/EC. It is based on the achievements of the acquis communautaire developed in this area and the principle of free movement of goods (Article 34 TFEU) and its exceptions set out in Article 36 TFEU concerning the protection of human health and life. The commented judgment sets an example of one more verdict confirming the interpretation of Articles 34 and 36 TFEU, according to which national provisions of a Member State should be considered unacceptable, according to which the withdrawal of the marketing authorisation for the reference medicinal product in the country of import has the automatic effect of expiring the parallel import authorisation. At the same time, new circumstances affecting the safety of the medicinal product on the market were analysed to give the conclusion as declared in the sentence.

Medicinal products are a special type of goods due to their importance for human health and life, and their trade is generally under the scope of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. The preamble to this act states that the essential aim of the rules governing the production, distribution and use of medicinal products must be to safeguard public health. Hence, in the above-mentioned directive, the rules related to the authorisation of medicinal products for marketing and pharmacovigilance are very important. At the same time, it should be noted that parallel import of medicinal products as a form of trade in an EU Member State in connection with their authorisation for marketing in another Member State, although it has a long tradition, has not had a clear normative pattern, and has not been subject to the scope of Directive 2001/83/EC. It is based on the achievements of the acquis communautaire developed in this area and the principle of free movement of goods (Article 34 TFEU) and its exceptions set out in Article 36 TFEU concerning the protection of human health and life. The commented judgment sets an example of one more verdict confirming the interpretation of Articles 34 and 36 TFEU, according to which national provisions of a Member State should be considered unacceptable, according to which the withdrawal of the marketing authorisation for the reference medicinal product in the country of import has the automatic effect of expiring the parallel import authorisation. At the same time, new circumstances affecting the safety of the medicinal product on the market were analysed to give the conclusion as declared in the sentence. [ABSTRACT FROM AUTHOR]

The issue of occupational diseases in chemical and pharmaceutical workers is urgent because it stems from the rapid pace of development, the functional features, and the high biological activity of raw materials used by that industry. The study is aimed at summarizing the information on preconditions and nature of occupational diseases among chemical and pharmaceutical workers based on the analysis of literature data. An important prerequisite for the emergence of occupational diseases is the shortcomings in the production process, leading to pollution of surfaces and workspace air with chemicals through the use of semi-automatic equipment in particular. The harmful substances then enter the bodies of workers through the respiratory system, which is the main and most harmful way. The most dangerous processes are the production and processing of substances with high pharmacological activity, and thus the active pharmaceutical ingredients maybe considered to be the leading causative agents of occupational diseases in the industrial production of medicinal products. The range of diseases diagnosed in pharmaceutical workers is diverse and includes acute intoxication, effects on internal organs, reproductive function, changes in hormonal status, and changes in the hemic system and nervous system. The most common are diseases of respiratory organs and diseases of allergic origin. As a result, influential international organizations and many authors emphasize the need to develop criteria and methods for assessing the harmful effects of medicinal products on the health of workers when authorizing their production.

Dendrobium brymerianum Rchb. f. is a species of orchid with pharmacological interest for its potential to inhibit the growth of human lung cancer cells. The identification of the Dendrobium species is a notable problem due to morphological similarities and the limitations of universal DNA barcodes. To overcome these difficulties, this study employed complete chloroplast (cp) genome sequences as useful resources for the identification of D. brymerianum. Based on Illumina sequencing, the complete cp genomes of five D. brymerianum individuals were assembled. These genomes were in the quadripartite structure, diverse in length between 151,832 and 152,189 bp, and comprised 126 genes. Moreover, significant differences were found in the Small Single-Copy (SSC) and Large Single-Copy (LSC) regions in comparison to the Inverted Repeat (IR) regions. This study recognized hotspot regions and simple sequence repeat (SSR) loci, providing valuable insights into genetic markers. The phylogenetic relationship of Dendrobium species was discovered, highlighting the need for more precise differentiation practices. To address this, ARMS-specific primers, mainly AAob1/AAob2, confirmed strong specificity, permitting the accurate identification of D. brymerianum from other species through ARMS-qPCR. Overall, this study of D. brymerianum chloroplast genomes has generated valuable data about sequence variations, phylogenetics, and mutation dynamics. These perceptions will be valuable in future research on population genetics, taxonomy, and species identification within the Dendrobium genus.

Interventions in the human germline, whether for purposes of therapy for a hereditary disease or for purposes of enhancement, are controversial. While enhancement is almost unanimously rejected, therapy-oriented intervention is not a priori regarded as unacceptable. The legal discussion so far has focused primarily on the questions of whether manipulation of the embryo's germline is permissible or whether the genetic manipulation of germ cells and the use of these germ cells for embryo generation is permissible. Up to now, the upstream questions regarding the systematic germline therapy development in clinical trials have been ignored, including questions as to whether the development of germline therapy would be legally permissible within the European Union framework of clinical studies. This article highlights the legal issues connected with the clinical development of germline intervention, provides an overview of the various answers to these legal questions, and indicates where further research and discussion are needed. [ABSTRACT FROM AUTHOR]

Vaccines have continued to play a crucial global role in preventing infectious diseases in the twenty-first century. The Covid-19 pandemic has underlined their importance, with vaccines seen as the best way to protect the public from coronavirus. A longstanding problem of governments has been the extent to which they should assume responsibility for the compensation of those injured by vaccines. This paper reappraises the vaccine damage schemes currently available in the US and UK in the light of the Covid-19 pandemic. It argues that any improvements to both US and UK schemes should be included in a revised national vaccine policy which takes into consideration their respective long-term national vaccine strategies to prepare for future pandemics. It supports the adoption of a UK-wide National Vaccine Injury Compensation Programme, similar to the one in the US, to be administered by the Secretary of State for Health and Social Care. To balance the need for rigorous criteria to determine causation with the need for fairness, the programme should adopt the US practice of allowing negotiated settlements between parties in circumstances where review of the evidence has not concluded that the vaccine(s) caused the alleged injury but there are close calls concerning causation. [ABSTRACT FROM AUTHOR]

The quality of pharmaceuticals has always been a concern to the World Health Organization (WHO) from the beginning its inception. Good Manufacturing Practice (GMP) is an important part of a comprehensive system of quality assurance (QA) for both manufacturers and the government. In Lebanon, and since its application, many challenges faced the implementation of the QA program according to GMP guidelines. Yet, this program has been successfully implemented in the Lebanese pharmaceutical industry supported by the Lebanese Ministry of Public Health (MOPH), and the commitment of the national GMP committee, in addition to the involvement of the public and private pharmaceutical sectors. The main objective of this study is to evaluate the implementation of the QA program according to GMP guidelines by selected Lebanese pharmaceutical companies. A descriptive analytical study was conducted between August-November of 2018, using a questionnaire that was administered to the quality departments of 10 Lebanese pharmaceutical companies. Finding showed that all these companies were implementing the QA programs according to GMP guidelines (100%), where 60% of their quality managers are experienced in GMP guidelines for more than 6 years. Further, 50% of these companies were applying QA program according GMP guidelines since more than 6 years, and 80% of them are formulating their programs using all the quality tools of the international GMP standards. Moreover, 80% of them are establishing awareness toward the implementation of GMP guidelines through training by internal expertise and external consultants. On the other hand, the implementation cost was the most important challenge faced by 60% of these firms. Finally, all companies are profiting by an increase in efficacy and efficiency, better product quality, and decrease in defects due to the implementation of the GMP guidelines. All the Lebanese pharmaceutical companies are working toward developing their program to meet the international standards, yet, they still need governmental support to spread and compete around the world. [ABSTRACT FROM AUTHOR]

This article addresses the issue of advertising of medicinal products from the perspective of protecting the consumer’s interest. As the research problem of the article was chosen to reconstruct the normative pattern of indirect consumer protection against incompatible with the provisions of PrFarm advertising of medicinal products directed to the public. The paper uses the dogmatic-legal method. In order to be able to solve the research problem posed, it was necessary to analyze the current state of the law with reference to doctrine and case law. The chosen research method made it possible to answer the research questions posed in the study concerning, among other things, whether the current form of supervision of advertising of medicinal products (or more precisely: supervision of the legality of advertising of medicinal products) is sufficient, and whether the patient/consumer is effectively protected from inconsistent PrFarm advertising of medicinal products directed to the public. As a result of the study, it was concluded that the current regulations on supervision of advertising of medicinal products to the public are not sufficiently effective, as they do not sufficiently protect the interests of the consumer. The above made it possible to propose changes to the current regulations in the form of introducing ex ante control of advertising of medicinal products to the public.

The issue of occupational diseases in chemical and pharmaceutical workers is urgent because it stems from the rapid pace of development, the functional features, and the high biological activity of raw materials used by that industry. The study is aimed at summarizing the information on preconditions and nature of occupational diseases among chemical and pharmaceutical workers based on the analysis of literature data. An important prerequisite for the emergence of occupational diseases is the shortcomings in the production process, leading to pollution of surfaces and workspace air with chemicals through the use of semi-automatic equipment in particular. The harmful substances then enter the bodies of workers through the respiratory system, which is the main and most harmful way. The most dangerous processes are the production and processing of substances with high pharmacological activity, and thus the active pharmaceutical ingredients maybe considered to be the leading causative agents of occupational diseases in the industrial production of medicinal products. The range of diseases diagnosed in pharmaceutical workers is diverse and includes acute intoxication, effects on internal organs, reproductive function, changes in hormonal status, and changes in the hemic system and nervous system. The most common are diseases of respiratory organs and diseases of allergic origin. As a result, influential international organizations and many authors emphasize the need to develop criteria and methods for assessing the harmful effects of medicinal products on the health of workers when authorizing their production. [ABSTRACT FROM AUTHOR]

Over the past thirty years, international requirements for the quality of honey have significantly increased due to the contamination of honey with chemical substances, namely with regard to the residual amount of pesticides, antibiotics and heavy metals in it. The purpose of this study was to study the regulatory documents of Ukraine, the European Union and other countries, in particular the USA and Canada, with the aim of bringing the Ukrainian honey standard into compliance. The data of the state standard of Ukraine for honey DSTU 4497:2005 [38], EU Directive 2001/110/EC [40], and normative documents of the USA and Canada were used as research material. An analysis of the degree of contamination of honey with medicinal preparations was carried out. It is proposed to make changes to the new version of the normative document of Ukraine on honey on the maximum permissible amount of medicinal products, based on the regulatory documents of the European Union and the USA and Canada. When revising the current standard of Ukraine for honey, it is recommended to introduce the following norms of the permissible level of pesticides, no more than mg/kg: hexachloran - 0.5; coumaphos - 0.1; amitraz - 0.2; tau-flaminate - 0.02. Regarding the maximum permissible levels of the content of antibiotics and other medicinal products, determine their amount within the following limits, no more than mg/kg: oxytetracycline - 0.1; tetracycline - 0.1; nitrofuran - 0.6; chloramphenicol - 0.3; and streptomycin - 0.1. A study was conducted comparing the permissible content of such harmful substances in honey as lead, cadmium and arsenic according to various documents among Ukraine, the EU and the USA. It is recommended in the new edition of the standard of Ukraine for honey to reduce the maximum permissible level of lead content in it by 2 times and to set this indicator at the level of 0.5 mg/kg. The benefit from this study is to obtain a updated and harmonized with EU and USA normative document of Ukraine on honey, based on the data of indicators of such documents from other countries. The study's practical significance is the use of the obtained conclusions and developments as recommendations for improving the regulatory document of Ukraine on honey. [ABSTRACT FROM AUTHOR]

Wildlife exposures to pest controlling substances have resulted in population declines of many predatory species during the past decades. Many pesticides were subsequently classified as persistent, bioaccumulative, and toxic (PBT) and banned on national or global scales. However, despite their risks for non-target vertebrate wildlife, PBT substances such as anticoagulant rodenticides (ARs) are still permitted for use in Europe and have shown to threaten raptors. Whereas risks of ARs are known, much less information is available on emerging agrochemicals such as currently used PPPs and medicinal products (MPs) in higher trophic level species. We expect that currently used PPPs are relatively mobile (vs. lipophilic) as a consequence of the PBT criteria and thus more likely to be present in aqueous matrices. We therefore analyzed blood of 204 raptor nestlings of three terrestrial (red kite, common buzzard, Montagu's harrier) and two aquatic species (white-tailed sea eagle, osprey) from Germany. In total, we detected ARs in 22.6% of the red kites and 8.6% of the buzzards, whereas no Montagu's harriers or aquatic species were exposed prior to sampling. ΣAR concentration tended to be higher in North Rhine-Westphalia (vs. North-Eastern Germany) where population density is higher and intense livestock farming more frequent. Among the 90 targeted and currently used PPPs, we detected six substances from which bromoxynil (14.2%) was most frequent. Especially Montagu's harrier (31%) and red kites (22.6%) were exposed and concentrations were higher in North Rhine-Westphalia as well. Among seven MPs, we detected ciprofloxacin (3.4%), which indicates that risk mitigation measures may be needed as resistance genes were already detected in wildlife from Germany. Taken together, our study demonstrates that raptors are exposed to various chemicals during an early life stage depending on their sampling location and underpins that red kites are at particular risk for multiple pesticide exposures in Germany. [ABSTRACT FROM AUTHOR]

The study is focused on the legal regulation of state support for the creation of innovative medicinal products. Establishment of the measures of state support for scientific research for creating innovative medicinal products within legislative acts and by-laws should help to increase the competitiveness of the pharmaceutical industry in Ukraine. The government declares the provision of support for scientific research in the field of creating innovative medicinal products. The legislation establishes the conditions for registering an innovative project, provides the maintenance of the Register of scientific institutions that received the state support. A detailed characteristic of the existing means of the state support for scientific research in the pharmaceutical industry is provided. The state supports innovations by establishing tax incentives for research institutions and providing funding for some innovative projects. Support for innovations is carried out by the State Innovative Financial and Credit Institution, the National Research Fund of Ukraine and the Innovation Development Fund. Funding for the creation of innovative medicinal products can be realized through public and private partnership. The scholars have declared their propositions regarding the introduction of specific measures of the state support for innovations in the field of creating new medicinal products. It has been offered to amend the current legislation on the issues of state funding of scientific research in the sphere of developing new medicinal products. It is necessary to delineate the competence of various funds for promoting innovations in relation to supporting innovations in the field of pharmacia. It is important that the law should provide the procedure and conditions for supporting public and private partnership projects at the expenses of funds for promoting innovations.

Objectives: Purchasing medicinal products from the internet has become more popular in the last three decades. Understanding consumers’ use and perception of the safety of medicinal products obtained online is essential. Therefore, this study aims to evaluate the extent of medicines purchased from the internet in Saudi Arabia, types of products, sources of information, the satisfaction, the motivational factors, and estimate consumers’ vigilance and tendency to report ADRs if occurred. Design: A prospective cross-sectional study using a custom-designed questionnaire was conducted among community adults in Saudi Arabia, age ≥ 18. Setting: Evaluation of community subjects' perception towards buying medicinal products was done through the internet in Saudi Arabia from 1st July 2020 until the end of August 2020. Main outcome measure(s): The main outcome of the study was purchasing medicinal products from the internet (Yes, No). Results: Overall, 36% of the study participants (n = 643) have ever bought medicinal products from the internet (Table 2). Of those, the most obtained was herbal medicine, supplements, or cosmetics (61.3%). Motivational factors towards purchasing medicinal products from the internet were mostly positive, with the most commonly reported agreed motivational factors were lower cost (55.7%), easy online access (54.1%), a wide variety of products (52.6%), and more privacy (43.6%). Around 60.4% of participants believed that buying medicinal products from the internet can be safe. The most perceived risk was the difficulty of distinguishing between registered online pharmacies and other unlicensed commercial websites, with only 32.7% of the participants distinguishing between registered and unlicensed commercial websites. Conclusions: This study sheds light on the consumers’ use and perception of the safety and risks of medicinal products purchased from the internet. The study findings noticeably describe the great need to increase safety awareness about obtaining medicinal products from the internet among the Saudi community.

Regulation (EU) 2017/745 provides for new provisions for medical devices made of substances as well as specific classification rules and requirements. The demarcation line between medical devices composed of substances and medicinal products is not always easy to define. The recent publication by the European Commission of the guidance on borderline between medical devices and medicinal products under the Regulation (EU) 2017/745 on medical devices, MDCG 2022-5, addresses some important issues in this topic. This article will discuss some controversial aspects in this field in order to clarify the product qualification process.

Vaccines have played an essential role in advancing medical treatment in the twentieth and twenty-first centuries. However, no medical intervention is risk free, and vaccines are no exception to that rule. This article considers how lawyers have confronted or eschewed risk–benefit in the context of determining defectiveness in vaccine liability, with emphasis on the UK, European Union, and US experiences. It explores the potential role that risk–benefit may play in assessing liability for vaccines against the COVID-19 pandemic. It argues that a holistic, flexible approach to determining defectiveness embracing risk–benefit allows consideration of the overwhelming public interest derived from the continued availability and supply of vaccines, as well as immunity conferring benefits on both the individual and the community. If cases do emerge concerning the liability of a COVID-19 vaccine, immunity conferring benefits on both the individual and the community of the COVID-19 vaccines should be relevant in any determination of defectiveness. Such a holistic, flexible approach to defectiveness embracing risk–benefit can be used effectively to determine the entitled safety of a vaccine and may help to mitigate against the dangers of weakening confidence in the public's vaccine uptake. [ABSTRACT FROM AUTHOR]

Subject and purpose of work: The subject matter of the study is irregularities in the distribution channels of medicinal products, medical devices and foodstuffs for particular nutritional uses. The inversion of distribution on the Polish pharmaceutical market has taken the form of illegal export of medicinal products, becoming one of the main aspects of cross-border crime. The purpose of the study is to identify the causes, present the essence and point to the effects of uncontrolled exports of pharmaceuticals for the Polish medicinal products supply system.

Background: The manufacture of medicinal products for human use in the European Economic Area is governed by European Directives and Regulations stipulating the relevant principles and guidelines of Good Manufacturing Practice, describing the minimum standard to be fulfilled in the production processes. Aim: To present analysis of the deficiencies reported following Good Manufacturing Practice inspections in Bulgaria in two consecutive years (2016, 2017) and to compare them with results from similar inspections reported by other EU member states. Materials and methods: A retrospective study was carried out by reviewing the complete Good Manufacturing Practice inspection reports of all manufacturers conducted by the Bulgarian Drug Agency in 2016 and 2017, according to relevant requirements and applicable local legislation. The items reviewed were scope of inspection, type of companies, classification of deficiencies – ‘critical’, ‘major’ and ‘other significant deficiencies’, their nature and reference to EU Good Manufacturing Practice. Results: The analyzed data included 55 inspections, revealing 460 various deficiencies, of which 2 were critical and 102 – major. Twenty inspections were performed in 2016 vs. 35 inspections in 2017.The pattern of deficiencies was similar to the findings of other EU regulatory agencies, showing that equivalent requirements were applied. Our analysis showed that Bulgarian Drug Agency inspectors rarely raised deficiencies related to Computer Systems, Qualification/Validation, Personnel and Qualification of Suppliers unlike other EU regulators agents. Conclusions: Our analysis of Good Manufacturing Practice inspection findings in 2016 and 2017 showed that the Bulgarian Drug Agency demonstrated its ability to detect non-compliances and take necessary regulatory actions. Quality related issues constitute the main reasons for non-compliances with the requirements.Publishing the results from the inspections performed by the national competent authorities enhances the regulatory transparency that can be useful for industry to improve its Good Manufacturing Practice compliance.

Background: In 2019, it was estimated that approximately 1.4 million adults in the United Kingdom purchased illicit cannabis to self-treat chronic physical and mental health conditions. This analysis was conducted following the rescheduling of cannabis-based medicinal products (CBMPs) in the United Kingdom but before the first specialist clinics had started treating patients., Objective: The aim of this study was to assess the prevalence of illicit cannabis consumption to treat a medically diagnosed condition following the introduction of specialist clinics that could prescribe legal CBMPs in the United Kingdom., Methods: Adults older than 18 years in the United Kingdom were invited to participate in a cross-sectional survey through YouGov between September 22 and 29, 2022. A series of questions were asked about respondents' medical diagnoses, illicit cannabis use, the cost of purchasing illicit cannabis per month, and basic demographics. The responding sample was weighted to generate a sample representative of the adult population of the United Kingdom. Modeling of population size was conducted based on an adult (18 years or older) population of 53,369,083 according to 2021 national census data., Results: There were 10,965 respondents to the questionnaire, to which weighting was applied. A total of 5700 (51.98%) respondents indicated that they were affected by a chronic health condition. The most reported condition was anxiety (n=1588, 14.48%). Of those enduring health conditions, 364 (6.38%) purchased illicit cannabis to self-treat health conditions. Based on survey responses, it was modeled that 1,770,627 (95% CI 1,073,791-2,467,001) individuals consume illicit cannabis for health conditions across the United Kingdom. In the multivariable logistic regression, the following were associated with an increased likelihood of reporting illicit cannabis use for health reasons-chronic pain, fibromyalgia, posttraumatic stress disorder, multiple sclerosis, other mental health disorders, male sex, younger age, living in London, being unemployed or not working for other reasons, and working part-time (P<.05)., Conclusions: This study highlights the scale of illicit cannabis use for health reasons in the United Kingdom and the potential barriers to accessing legally prescribed CBMPs. This is an important step in developing harm reduction policies to transition these individuals, where appropriate, to CBMPs. Such policies are particularly important considering the potential risks from harmful contaminants of illicit cannabis and self-treating a medical condition without clinical oversight. Moreover, it emphasizes the need for further funding of randomized controlled trials and the use of novel methodologies to determine the efficacy of CBMPs and their use in common chronic conditions., (© Simon Erridge, Lucy Troup, Mikael Hans Sodergren. Originally published in JMIR Public Health and Surveillance (https://publichealth.jmir.org).)

To respond to the need for a vaccine against and a treatment for Covid-19, the German Federal Government (German government) used various economic incentives to promote pharmaceutical and biotechnological (biotech) research and development (R&D) as well as manufacturing. More specifically, it decided to subsidise several German companies working in this field. Such domestic measures might, however, present a challenge to European state aid law. It is against this backdrop that this article discusses the compatibility of the payments made with the new 'crisis-born' European legal framework for state aid. Furthermore, the article offers some critical comments on the aid's effects on solidarity and cohesion in the European Union (EU) and the proposals put forward for expanding the EU's health policy competencies. [ABSTRACT FROM AUTHOR]

The possibility of determining the active substances of antibacterial drugs of the tetracycline series (tetracycline, doxycycline, oxytetracycline, demeclocycline, metacycline, and chlortetracycline) using solid-phase fluorescence digital colorimetry is considered. The intrinsic fluorescence of tetracyclines and tetracycline-sensitized fluorescence of europium on cellulose paper and a thin layer of silica gel was studied. Yellow-green (tetracyclines) and pink (europium) fluorescence were observed upon irradiation with UV light (365 nm) of spots of tetracycline solutions applied to the matrix. The fluorescence intensity on the matrix surface was measured using a smartphone. Values of colorimetric parameters in the RGB system were used as the analytical signals (Ar). The limits of detection and quantitation were 1 – 5 and 3 – 17 μg/mL, respectively, for all analytes. The ranges of the determined concentrations were 3 – 500 μg/mL. The technique was tested for medicinal products. The relative standard deviation of the analytical results was ≤0.06. [ABSTRACT FROM AUTHOR]

Background: Benefit–risk assessments for medicinal products and devices have advanced significantly over the past decade. The purpose of this study was to characterize the extent to which the life sciences industry is utilizing quantitative benefit–risk assessment (qBRA) methods. Methods: Semi-structured interviews were conducted with a sample of industry professionals working in drug and/or medical device benefit–risk assessments (n = 20). Questions focused on the use, timing, and impact of qBRA; implementation challenges; and future plans. Interviews were recorded, transcribed, and coded for thematic analysis. Results: While most surveyed companies had applied qBRA, application was limited to a small number of assets—primarily to support internal decision-making and regulatory submissions. Positive impacts associated with use included improved team decision-making and communication. Multi-criteria decision analysis and discrete choice experiment were the most frequently utilized qBRA methods. A key challenge of qBRA use was the lack of clarity regarding its value proposition. Championing by senior company leadership and receptivity of regulators to such analyses were cited as important catalysts for successful adoption of qBRA. Investment in qBRA methods, via capability building and pilot studies, was also under way in some instances. Conclusion: qBRA application within this sample of life sciences companies was widespread, but concentrated in a small fraction of assets. Its use was primarily for internal decision-making or regulatory submissions. While some companies had plans to build further capacity in this area, others were waiting for further regulatory guidance before doing so. [ABSTRACT FROM AUTHOR]

Purchasing medicinal products from the internet has become more popular in the last three decades. Understanding consumers' use and perception of the safety of medicinal products obtained online is essential. Therefore, this study aims to evaluate the extent of medicines purchased from the internet in Saudi Arabia, types of products, sources of information, the satisfaction, the motivational factors, and estimate consumers' vigilance and tendency to report ADRs if occurred. A prospective cross-sectional study using a custom-designed questionnaire was conducted among community adults in Saudi Arabia, age ≥ 18. Evaluation of community subjects' perception towards buying medicinal products was done through the internet in Saudi Arabia from 1st July 2020 until the end of August 2020. The main outcome of the study was purchasing medicinal products from the internet (Yes, No). Overall, 36% of the study participants (n = 643) have ever bought medicinal products from the internet (Table 2). Of those, the most obtained was herbal medicine, supplements, or cosmetics (61.3%). Motivational factors towards purchasing medicinal products from the internet were mostly positive, with the most commonly reported agreed motivational factors were lower cost (55.7%), easy online access (54.1%), a wide variety of products (52.6%), and more privacy (43.6%). Around 60.4% of participants believed that buying medicinal products from the internet can be safe. The most perceived risk was the difficulty of distinguishing between registered online pharmacies and other unlicensed commercial websites, with only 32.7% of the participants distinguishing between registered and unlicensed commercial websites. This study sheds light on the consumers' use and perception of the safety and risks of medicinal products purchased from the internet. The study findings noticeably describe the great need to increase safety awareness about obtaining medicinal products from the internet among the Saudi community. [ABSTRACT FROM AUTHOR]

The problem of dosing drugs at an early age is conditioned by specific metabolism of medicinal products (MP) in the child's body. Currently, there are a few clinical trials on the study of physiological characteristics in different periods of childhood and systematised data. It is still relevant to understand the characteristic differences that affect the bioavailability, distribution and excretion of MP, especially in children over one month of life. The results of such studies are necessary in order to formulate the recommendations for use of MP in children taking into account their age and compensate for the lack of data from direct clinical trials in pediatrics. The possibility of using a dose calculation method regarding the fat content of the body in different periods of childhood and the chemical properties of the substance has been discussed.

(Series Information) European Papers - A Journal on Law and Integration, 2018 3(2), 1005-1016 | European Forum Insight of 13 June 2018 | (Table of Contents) I. Introduzione. - II. Il caso. - III. Le conclusioni dell'AG Saugmandsgaard Øe. - IV. La sentenza della Corte di giustizia. - V. Le informazioni ingannevoli nel diritto dell'Unione e quale problema rilevante per il diritto della concorrenza. - VI. Conclusioni. | (Abstract) In a recent case (judgment of 23 January 2018, case C-179/16, Hoffmann-La Roche and others), the Court of Justice held that an arrangement put in place between two undertakings marketing two competing products, which concerned the dissemination of misleading information relating to adverse reactions resulting from the use of one of those medicinal products, with a view to reducing competitive pressure, constituted a restriction of competition "by object" for the purposes of Art. 101, para. 1, TFEU. The purpose of this Insight is to provide an analysis of the case, focusing on both the opinion of the Advocate General and the judgment, and to provide further examples that prove that the dissemination of misleading information in the pharmaceutical field has become a competition law problem.

This review addresses the history of the creation of standard samples (SS) around the world and in Russia, along with studies of the current condition of the state system for standardization of medicinal products (MP) based on the use of SS. Standardization in the area of drugs is directed to guaranteeing the quality of the items standardized, which includes products (raw materials, other materials, ready MP, etc.), services, and processes. The continuing development of manufacturing technologies and the discovery of novel MP increases the need for standard samples, as drug quality control involves the use of complex, highly effective, specific, and precise physicochemical and biological analysis methods. [ABSTRACT FROM AUTHOR]

In the beginning of 2020 the world faced a new, unknown heath threat caused by a novel coronavirus outbreak. The preceding 2009 H1N1 pandemic urged many health authorities and organizations worldwide to revise and update their prevention and control protocols in case of infectious diseases but the present situation caught them unprepared for the magnitude of morbidity and mortality that COVID-19 causes. Thousands of people lost their lives in just few months, health services are seriously upended and the economic losses are expected to reach unexpected levels. While the authorities are desperately trying to protect the public health and mitigate the negative economic impact of the measures designed to keep people safe, criminal originations actively engage in benefitting from the vulnerability of the legal and regulatory frameworks. The medicinal shortages combined with the lack of awareness in the society pose serious threat as panicked people turn to unauthorised and dangerous sources to buy pharmaceuticals and medical products. Their irrational and dangerous behaviour facilitate and significantly contribute to the uncontrolled spread of fakes as Internet provides perfect conditions for the unscrupulous dealers. The public is overwhelmed by a constant flow of disinformation that contain misleading and potentially dangerous recommendations and online offers for ―miracle cures‖. The disrupted legitimate supply chains provide further options for illegal structures to exploit the fear of the society and profiteer from the global crisis. The present material aims to review and analyse the main reasons that incite people to voluntary take part in such offences. It also points out the relevant areas that stakeholders should focus their efforts to fight back a parallel health threat - the falsified medicinal products. The key counteractions and recommendations undertaken by renown international and European organizations and institutions are summarized and a discussion is raised with reference their adoption, stricter implementation and further development. If policymakers engage more actively to strengthen their legal and regulatory frameworks against falsified medicinal products, their efforts would result in better preparedness and response in case of future health crises and in increased trust in governments and healthcare systems. [ABSTRACT FROM AUTHOR]

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Comparability is a key concept in the evaluation of both manufacturing changes and biosimilars. It constitutes a pragmatic and flexible approach which recognises that biologicals are inherently variable and that minor variations in quality attributes are often clinically irrelevant. In this discussion paper, we argue that comparability exercises rely on a number of pragmatic criteria. These criteria have been remarkably robust for 20 years of comparability exercises; however, the increased scrutiny of biosimilar applications provides an impetus for both codification and improvement of criteria for establishing comparability. Such a more rigorous, methodologically sound, approach towards comparability seems both feasible and beneficial. [ABSTRACT FROM AUTHOR]

A variety of medicinal products have been associated with rash and normally this information should be available in the Summary of Product Characteristics (SmPCs). Our study aimed to investigate the frequency of rash as an adverse drug reaction, based on the information provided by SmPCs of 1,048 single active substances (international non-proprietary names) authorized in the United Kingdom. Data on rash frequency was collected from each SmPC using automated searches based on selected keywords. Data analysis was carried out using R, v. 3.4. We found that over 90% of the medicines used orally or by injection may be associated with rash as an adverse event, the most common classes being protein kinase inhibitors, anticancer medicinal products, monoclonal antibodies, biologicals, antivirals and retinoids, with high variations in rash frequency for products within the same class, but also for products with the same active substance. Analysis of SmPCs revealed the need to increase homogeneity in reporting rash frequency, by using Council for International Organizations of Medical Sciences classification, and Medical Dictionary for Regulatory Activities coding in a more standardized manner, and also the need to include more safety endpoints in clinical trials and to use better the safety results for publication and updating the SmPCs. [ABSTRACT FROM AUTHOR]

Purpose: Centrally authorised medicinal products (CAMPs) in the European Union may offer added therapeutic value (ATV) but may be linked to high prices and limited efficiency. Health technology assessment (HTA) and managed entry schemes (MES) may facilitate the reimbursement decision by providing reliable estimates of the medicinal product's value and costs and by controlling the remaining uncertainty, respectively. We investigated the impact of HTA criteria and the initiation of a MES on the reimbursement decision of CAMPs in Belgium. Methods: We selected all reimbursement submissions for new centrally authorised medicinal products in the 2010–2015 period. We retrieved data relating to the reimbursement decision, the HTA outcome and the use of a managed entry scheme. Results: The decision of the Minister was available for 115 dossiers, covering 36 (31.3%) orphan medicinal products (OMPs) and 79 ATV products. A MES was used in 41 submissions. A positive reimbursement decision was obtained in 65% of cases. The significant factors affecting the reimbursement decision were the approval of ATV, the medical need if it was considered 'important or major' and the use of a managed entry scheme. Price, budget impact and efficiency had no significant impact. Conclusions: Added therapeutic value and high medical need increase the odds for a positive reimbursement decision. No impact could be demonstrated of the cost-related HTA criteria. Cost elements may be biased by the use of a confidential MES. Without a MES, only 53% of the centrally authorised medicinal products, including OMPs, are reimbursed in Belgium. [ABSTRACT FROM AUTHOR]

We provide an overview of the regulatory framework, pathways and underlying regulatory authority for cell, gene and tissue-engineered therapies in Canada. Canada's regulatory approach uses three sets of regulations, namely, the Cells, Tissues and Organs Regulations, the Food and Drug Regulations and the Medical Devices Regulations. We provide an overview of each these sets of regulations as they apply to clinical investigation to post-market product lifecycle stages. Information is provided on the current sources of relevant Health Canada guidance documents. We highlight several regional success stories including Prochymal, a cell therapy product that achieved Canadian regulatory approval using the conditional marketing approval system. We also examine the perceived gaps in the Canadian regulations and how those gaps are being addressed by interactions between the government, stakeholders and international bodies. We conclude that the risk-benefit approach used by Health Canada for regulatory approval processes is sufficiently flexible to enable to development of novel cell and gene therapy products in Canada, yet stringent enough to protect patient safety. [ABSTRACT FROM AUTHOR]

The current study analyses the regulatory inspection findings of the wholesalers in Bulgaria in 2017 and compares the results with the findings from some other EU member-states. In total, 48 GDP inspections were performed in 2017. 50% of the inspections were performed in relation with issuing an authorization for wholesale of medicines, the rest half were related to changes in already granted authorizations. During the inspections, 17 non-conformities (NCs) have been documented. The NCs were identified in 3 wholesalers and 6 deficiencies were classified as major. No critical deficiencies were found. NCs were found in 6.25% of the inspected companies. No critical NCs were identified and only 6 NCs were classified as major which demonstrated high level of compliance of distributions sites in Bulgaria with the requirements of GDP. [ABSTRACT FROM AUTHOR]

The off-label use of medicinal products raises many interpretation-related issues, not only among physicians but also pharmacists and lawyers. The use of drugs in a manner other than that specified in the Summary of Product Characteristics is not regulated by Polish law. The authors' goal is to discuss the topic mainly from the practical perspective, while also considering its theoretical aspects, and to identify systemic solutions to several problems, that are extremely important for the proper functioning of the entire healthcare system. The paper highlights that there is a fine line between experimental medicinal practices and those that are in keeping with current medical knowledge. [ABSTRACT FROM AUTHOR]

As a result of the constantly increasing number of innovative but exceedingly high priced medicines, many Member States have implemented price-regulating mechanisms to ensure the financial viability of their healthcare systems. However, the European Court of Justice applies strict criteria to these measures - some of them have already been suspended for the purposes of the free movement of goods. The European Union (EU) allowed the development of an ever-stricter case law on one hand, without changing the legal frame on the other hand. Considering the importance and the binding nature of the Court's judgements, this leaves great uncertainty for national legislators about which measures to remedy the pricing problem are legally possible and which are not. In order to provide clarity, this article seeks to analyse the development of the case law and to define the legal scope for pharmaceutical pricing mechanisms in the EU. [ABSTRACT FROM AUTHOR]

General approaches to the elaboration of pharmacopoeial quality standards for medicinal products that are based on good pharmacopoeial practice (GPhP) rules of domestic and leading foreign pharmacopoeias are presented. [ABSTRACT FROM AUTHOR]

Anna Staniszewska,1 Marta Dąbrowska-Bender,2 Dominik Olejniczak,2 Aneta Duda-Zalewska,2 Magdalena Bujalska-Zadrożny3 1Department of Experimental and Clinical Pharmacology, 2Department of Public Health, 3Department of Pharmacodynamics, Medical University of Warsaw, Warsaw, Poland Aim: The aim of the study was to assess patient knowledge on reporting of adverse drug reactions.Materials and methods: A prospective study was conducted among 200 patients. The study was based on an original survey composed of 15 single- and multiple-choice questions. The study involved individuals who have experienced adverse reactions as well as individuals who have never experienced any adverse reactions; people over the age of 18; literate; residing in Mazowieckie Voivodeship, who have not been diagnosed with any disease that could compromise their logical thinking skills.Results: The respondents who lived in the city had a greater knowledge compared to the respondents who lived in the countryside (Pearson’s χ2=47.70, P=0.0013). The respondents who lived in the city were also more statistically likely to provide a correct answer to the question about the type of adverse reactions to be reported (Pearson’s χ2=50.66, P=0.012). Statistically significant associations were found between the place of residence of the respondents and the correct answer to the question about the data that must be included in the report on adverse reactions (Pearson’s χ2=11.7, P