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The article reports that the World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) advises the Director-General of WHO in the area of medicines quality assurance. It mentions that the Committee oversees the maintenance of the International Pharmacopoeia and provides guidance for use by relevant WHO units and regulatory authorities in WHO Member States, to ensure standards of quality, safety and efficacy.

The World Health Organization (WHO) Certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce (hereinafter referred to as the "Scheme") has demonstrated its value as a tool for quality assurance during the importation and exportation of medicines for WHO Member States. Since its approval in 1969, it became more and more widely used by national regulatory authorities and its main document, The Certificate of a Pharmaceutical Product, has proved to be an essential instrument in providing information about relevant provisions already approved in marketing authorization, including the good manufacturing practices of manufacturers and for the prevention and detection of the export, import and smuggling of falsified or substandard pharmaceutical preparations. This voluntary agreement has evolved constantly in order to respond to the regulatory and pharmaceutical environment demands. This article summarizes the steps of the updating process of the Scheme since its creation, and particularly the modifications adopted during the last 14 years, until the endorsement of the revised Scheme by the Fifty-fifth WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) in 2020. The milestones of the evolution of the Scheme are listed and described herein and show the active follow-up by the ECSPP and the World Health Assembly on the matters arising during its implementation. In addition, the main 25 changes made to the Scheme are explained. These have been discussed and approved in the last period of revision based on the comments and suggestions received during the public consultations and the inputs of expert working group meetings, the pharmaceutical industry, and the national and regional regulatory authorities. The amendments made to the Scheme address the problems identified and the opportunities for improvement. Participating experts and regulators consider that the Scheme will serve and respond to the current and anticipated challenges. The surveillance and timely analysis of its proper use will be essential in order to obtain the expected benefits of reliance and access to medicines, according to the Scheme's objectives. [ABSTRACT FROM AUTHOR]

The article presents the discussion on Fifty-fifth meeting helding virtually from 12 to 19 October 2020 where ECSPP receiving updates on cross-cutting issues from other WHO bodies. Topics include World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) advising the Director-General of WHO in the area of medicines quality assurance; and revising specifications and general texts for quality control testing of medicines for inclusion.

The article discusses that storage and distribution are important activities in the supply chain management of medical products. It mentions that substandard and falsified products are a significant threat to public health and safety; and also mentions that medical products may be subjected to various risks at different stages in the supply chain.

The article outlines a proposed framework for evaluating and publicly designating regulatory authorities as ‘WHO-listed authorities', following upon recommendations from the fifty-first meeting of the World Health Organization (WHO). It mentions that several WHO guidance documents relating to the quality of medicines provide mechanisms; and also mentions that there have been increasing calls for a change in the term and definition given the inference regarding other authorities.

The article discusses that during the Joint Meeting on Regulatory Guidance for Multisource Products, several World Health Organization (WHO) guidances were identified for update. It describes the quality management system (QMS) requirements for the operation of inspection services within national regulatory authorities (NRA); and also mentions the adoption of a common standard for QMS requirements is an essential element in achieving consistency in inspection practices.

The article focuses on establishing policy for shelf life of medical products. Topics include discussion between the Interagency Pharmaceutical Coordination (IPC) group representatives to initiate a project for medical products; prevent dumping of the medical products; and prevent to having expired stock.

The article focuses on Institute of Medicine (IOM) report which described the mishmash of inconsistent training offered to low- and middle- income countries (LIMC) as part of the problem. Topics include progress in harmonizing technical standards, joint activities; and need to ensure universal promotion and protection of public health.

The article offers information related to the Polymorphism, which is the ability of an object to take on many forms, presented in monograph "The International Pharmacopoeia" by World Health Organization. Topics discussed include terminology associated with crystal polymorphism; analytical techniques commonly used to characterize polymorphs; and characterizing stability of solid forms.

The article focuses on 18th International Conference of Drug Regulatory Authorities held in Dublin, Ireland from September 3 to September 7, 2018. Topics discussed include promoting regulatory collaboration, convergence and harmonization throughout the products life cycle; improving coordination, risk-based prioritization of investments, reliance, work- sharing and use of regional networks; and promoting greater transparency, awareness and communication.

The article presents an assessment of global chemistry, manufacturing and controls (CMC) regulatory requirements in Low and Middle Income Countries (LMIC). Topics include the lack of visibility of regulatory requirements in LMIC can result in higher costs and patients' delayed access to drugs, and potential impact of increased visibility into LMIC CMC regulatory requirements for manufacturers, National Regulatory Authority (NRAs), and the global health community.

This is a draft proposal of a chapter for The International Pharmacopoeia (Working document QAS/17.716/Rev.1, May 2018). The draft has been revised based on the comments received during the public consultation held in July-- September 2017. The working document with line numbers is available for comment at www.who.int/medicines/areas/quality_safety/quality_assurance/ projects. [ABSTRACT FROM AUTHOR]

The article offers drug news briefs as of June 2018. A guideline was released by the European Medicines Agency (EMA) which describes requirements for choosing appropriate genomic methodologies during the development and the life cycle of a medicine. A final guidance was published by the MHRA on data governance systems across all good practice sectors.

WHO prequalifies vaccines for use in Member States. In 2016 WHO initiated the establishment of a Network of national control laboratories (NCLs) that test prequalified vaccines. The Network aims to reduce redundant lot release testing and contribute to more cost-effective testing, thereby improving overall regulatory oversight and reducing regulatory burden. An article about the Network was included in Issue 1 (2017) of this journal. At the end of 2017 the Network held its First General meeting, which marked the move to the operational stage. This paper provides an update on achievements and next steps. [ABSTRACT FROM AUTHOR]

Excerpts from the articles "Fair Pricing Forum", "Information guide on biosimilars" and "Regulatory reforms in Mexico" are presented which focus on fair pricing in health system, information guide on the use of biosimilars and regulatory reforms instituted by the government of Mexico.

On-site inspections of manufacturing and testing sites for medicines are resource-intensive for both regulators and manufacturers, especially as an increasing number of sites are located outside regulatory authorities' territories. To maximize the impact of limited resources, it is therefore good regulatory practice to leverage available evidence from other agencies as part of a risk-based inspection planning process. The Australian Department of Health's Therapeutic Goods Administration (TGA) has been using a risk- and reliance-based approach in inspection planning for some time. This article describes the TGA's pathways for granting good manufacturing practice (GMP) clearance. [ABSTRACT FROM AUTHOR]

The article discusses the necessity of ensuring cooperation in the field of medicines of the European Medicines Agency (EMA) and other agencies in the European Union (EU) networks with regulatory agencies outside of the region. Topics addressed include the challenges emanating from drug manufacturing and drug marketing, procedure followed in drug aproval in the EU system, and information sharing initiatives involving EU assessment report (AR). The regulations adopted in Asia is described.

The article presents a comparison of legislation related to pharmaceuticals in the East African Community (EAC). Topics addressed include the demographic characteristics of EAC partner states, initiatives to unify medicines regulation and legal framework for medicines regulations. The role of the national medicines regulatory authority (NMRA) in ensuring the efficacy, safety and quality of medicines is discussed.

This section offers regulatory news briefs as of November 3, 2014. The Government of Canada has approved transparency amendments in a proposed patient safety law named Vanessa's Law (Bill C-17). The U.S. Food and Drug Administration (FDA) has launched openFDA, an initiative aimed at facilitating public access to large public health datasets collected by the agency. The FDA has outlined expectations for the implementation of compounding provisions enacted into law in November 2013.

The article discusses the 16th International Conference of Drug Regulatory Authorities (ICDRA) which was held in Rio de Janeiro, Brazil on August 26-29, 2014 and hosted by the Brazilian Health Surveillance Agency ANVISA and the World Health Organization (WHO). It presents the conference's recommendations for various issues including the role of drug regulatory authorities in national health systems, regulators' role in access/availability and new trends in regulating medical devices.

The emergence and spread of artemisinin resistance calls for intensified efforts to withdraw oral artemisinin-based monotherapy (oAMT) from the markets. Despite substantial progress, oAMTs are still available in many countries. Intensified action is needed to protect the therapeutic life of artemisinin- based combination therapy (ACT), the mainstay of treatment for malaria caused by Plasmodium falciparum . No alternative medicine is ready to enter the market in the next few years to replace ACTs. The loss of this life- saving class of medicines would have devastating consequences. [ABSTRACT FROM AUTHOR]

The article discusses the launch of the International Generic Drug Regulators Pilot (IGDRP) for the regulatory convergence and cooperation of the international pharmaceutical industry in 2014. According to the author, the three-year pilot will involve a series of concrete measures to facilitate the timely authorization and availability of safe and effective generic medicines.

The article focuses on the Collaborative Registration Procedure (CRP) for World Health Organization (WHO)-prequalified products which aims to leverage the work of the Prequalification of Medicines Programme (PQP) during registration and allow medicines regulatory authorities (MRAs) to use results of PQP assessments and inspections. Topics include the CRP principles, the rules of information sharing and the experience of 10 MRAs who joined the pilot phase organized during the 2nd half of 2012.

The article presents an overview of pharmacopoeias, which are collections of standards and quality specifications for medicines used in a country or region. An overview of the World Health Organization's International Pharmacopoeia, and of pharmacopoeias from countries across the globe, is presented. International legislation related to pharmacopoeias is discussed.

The article presents 2013 news on health.Ten African countries joined a World Health Organization initiative to speed up access to medicines and expertise in medicines regulation.The World Health Organization will combat counterfeit medical products with a counterfeit medical products prevention initiative from the World Health Assembly. The U.S. Agency for International Development's Programme for Promoting the Quality of Medicines will lead efforts against multidrug resistant tuberculosis.

The article reports on topics which were discussed at the 15th International Conference of Drug Regulatory Authorities (ICDRA), which took place in Tallinn, Estonia on October 23-26, 2012. Topics included the quality of active pharmaceutical ingredients, the regulation of the pharmaceutical industry and the role of drug regulatory agencies. The event was attended by members of drug regulatory agencies from across the globe, including the U.S. Food and Drug Administration.

The article presents 2012 and 2013 news on regulatory action related to drugs. The U.S. Food and Drug Administration has announced that it is forming an internal task force to support development of new antibacterial drugs. Great Britain's National Institute for Biological Standards and Control will become a part of the Medicines and Healthcare products Regulatory Agency on April 1, 2013. The government of Pakistan enacted the Drug Regulatory Authority of Pakistan bill on November 12, 2012.

In assessing pharmaceutical product dossiers for prequalification, the dossier assessment team of the WHO Prequalification of Medicines Programme (PQP) evaluates product data in close cooperation with inspectorates and other experts. PQP draws from the expertise of a pool of assessors from a variety of regulatory environments, including countries with sophisticated pharmaceutical industries and countries where prequalified medicines are used. To build regulatory capacity in the latter environments, PQP invites assessors for a three-month rotational period at the World Health Organization (WHO) in Geneva, Switzerland. Since 2006, 16 assessors from nine different countries have completed a rotation. This article describes the setting of the PQP rotational fellowship programme, summarizes the benefits and challenges of the rotations as described in feedback received from former fellows, and highlights the impact on building regulatory capacity, which has helped to increase patient access to good quality medicines. [ABSTRACT FROM AUTHOR]

Over the past decade, China has introduced significant changes to the regulation of medicines through modernizing its legislative framework in line with international practice and by re-organizing the nation's medicines administrative agency, the State Food and Drug Administration (SFDA). Medicines regulatory agencies (MRAs) have been established at national, provincial, city and county levels and, by the end of 2010, there were 2898 administrative organs and 1076 public institutions employing human resources of 45,393 and 24,939 respectively (1). The State Food and Drug Administration (SFDA) is the responsible agency for medicines administration nationwide. The medicines regulatory agencies at provincial level are responsible for drug regulation in their administrative areas while the responsibilities of local level MRAs are legally defined or commissioned by upper level MRAs. Administratively, mainland China consists of 31 contiguous regions at provincial level, 333 at city level and 2856 at county level (2). As of November 2010, China registered an overall population of 1339,724,852 (3) and, in 2010, the country's gross domestic product amounted to RMB 40120.2 billion (4). This article provides insight into changes taking place in the organizational structure, legislative framework and current situation of medicines regulation in China with a focus on medicines registration, manufacturing, distribution and use, advertising, and post-market safety monitoring as well as control of narcotics and psychotropic substances*. It also draws a picture of China's pharmaceutical industry and offers a glimpse of the transformations taking place in the medicines regulatory scene set against a backdrop of international harmonization. [ABSTRACT FROM AUTHOR]

The article presents questions and answers related to the World Health Organization Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce, including what the scheme is, how the scheme will facilitate trade in pharmaceutical products and how a World Health Organization member state or organization can become eligible for the scheme.

The article presents news on medications. On February 11, 2011 France's Health Products Safety Agency suspended the marketing authorization for medications containing buflomedil. The U.S. Food and Drug Administration has approved abiraterone acetate in combination with prednisone to treat prostate cancer. The U.S. Food and Drug Administration (FDA) has approved rituximab in combination with glucocorticoids to treat patients with Wegener granulomatosis and microscopic polyangiitis.

A personal narrative is presented which explores the author's experience of attending the third International Conference of Drug Regulatory Authorities in Sweden in 1995.

The article discusses several topics which were addressed at the 14th International Conference of Drug Regulatory Authorities, which was held in Singapore on November 30-December 3, 2010 and was hosted by the Health Sciences Authority of Singapore. Topics included drug regulation, the challenges of biomedical advancement and the collaboration of drug regulatory agencies. The event was attended by several educators and professionals including Margaret Hamburg, John Lim and Alar Irs.

The article presents an overview of the objectives and focus of the World Health Organization Prequalification of Medicines Programme. The program was developed to help national medicines regulatory agencies be better able to comprehensively evaluate the quality, safety and efficacy of medicinal products based on information submitted by manufacturers and to be better able to inspect the corresponding manufacturing and clinical sites.

The article describes information about pharmaceutical guidelines which were discussed at the International Conference on Harmonization (ICH) held in June 2009. The issues discussed included the implementation of ICH guidelines, international implementation of regulatory frameworks and recommendations for certain information to be included in the text, "The International Pharmacopoeia."

The article focuses on the concern over the spread of substandard and counterfeit medicines worldwide, with emphasis on the efforts of health organizations in Latin America to fight this problem. It notes the formation of the Pan American Network for Drug Regulation Harmonization (PANDRH) Anti-Counterfeiting Group and the Argentine National Investigation Programme to combat forgery and mislabelling of medical products. Cases of marketing counterfeit drugs in Argentina are also noted.

The article discusses the significance of international harmonization of pharmacovigilance on drug regulation and monitoring. It explains the impact of harmonization on the international drug trade and on patient safety. Information on the Pan American Network for Drug Regulatory Harmonization (PANDRH) is presented.

Information on the papers discussed at the Thirteenth International Conference of Drug Regulatory Authorities (ICDRA) which was held in Berne, Switzerland on September 16-19, 2008 is presented. Topics include the Good Governance for Medicines (GCM) programme of the World Health Organization (WHO), regulation of herbal medicines and strategies to combat counterfeit medicines. The event featured presentations of experts from 96 participating countries.

The article presents on the proposal for improvement of the World Health Organization (WHO) Certification Scheme. It notes on the current scheme that has been refined after five years from its initial endorsement based from field trials, consisting three different types of certificates. Moreover, a summary is illustrated on the problems identified in the implementation of the scheme and measures taken in it.

The article offers information on the project of Harmonization of Medicines Regulation in Africa (AMRHI) proposed by the World Health Organization (WHO). The project aims to improve health in the African region by increasing access to safe and effective medicines of good quality, which can be accomplished by strengthening the technical and administrative capacity of participating national medicines regulatory authorities.

The article discusses the highlights of the International Conference of Drug Regulatory Authorities (ICRDA) held in Seoul, Republic of Korea from April 3 to 6, 2006. The conference was segregated into the different seminars including "Biological medicines," "Strengthening regulation of biologicals" and "Issues related to the regulation of blood products." The results of the conference were improved comprehension of the issues involving quality assurance of biological drugs, added recognition of regulatory oversight for medicines and prioritized concerns.

The article provides information of essential lists of medicines and formularies which are valuable as public health tools in balancing the safety, efficacy and cost of drugs. It offers a summary on a comparative study to investigate the World Health Organization (WHO) Model List of Essential Medicines as a suitable tool for reviewing and generating of drug formularies in developed countries. It also establishes an analysis of the WHO Model List of Essential Medicines and the Scottish Lothian Joint Formulary.

The article provides information on the recommendations concerning drug regulations by the International Conference of Drug Regulatory Authorities that was held in Seoul, Republic of Korea on April 3 to 6, 2006. It points out measures to provide regulatory pathways in the access to medicines, emerging diseases and crises management, regulation of vaccines, and providing safety and quality herbal medicines. It also states the role of drug regulators in controlling advertising and promotion of drugs.

Reports on developments in drug regulatory and safety action in the U.S. as of August 2003. Revised prescribing information on topiramate for the treatment of oligohidrosis; Food and Drug Administration's approval of first biotechnology product omalizumab for the treatment of patients with allergy-related asthma; Approval of over-the-counter omeprazole for treating heartburn.

Describes the development of good clinical practices in China. Drug administration law; Regulations on new drug clinical evaluation; Ethical principles and trial subject protection; Requirements for foreign agencies conducting clinical studies in China; Shortcomings in GCP management.

Examines the importance of risk assessment in drug regulatory system. Responsibility of government health sector and drug manufacturers; Discussion on the risks related to drug production and improper use of drugs; Link between drug regulation and economic factors in health area; Advice from World Health Organization.

This section offers news briefs on pharmaceutical regulations. Canada has passed the Protecting Canadians from Unsafe Drugs Act or Vanessa's Law. The project WEB-RADR aims to collate information on suspected adverse drug reactions (ADRs) by use of smartphones and social media. More than a thousand active substances in approved medicines have been added by the European Medicines Agency (EMA) in its website for suspected ADRs.

Features the Ninth International Conference of Drug Regulatory Authorities slated in April 1998 in Berlin, Germany providing recommendations to support drug regulatory activities worldwide. Efficient regulatory practice; Certification practice; Counterfeit drugs; Drug utilization; Reduction of tobacco use.