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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.

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.

Excerpts from the articles "New measures to inform Canadians of the risks of prescription opioids out for consultation" and "Draft guidance on provision of data on antimicrobial use by animal species from national data collection systems" are presented which focus on regulatory rules.

The article discusses that the WHO Prequalification Team - Medicines has now withdrawn the Notice of Concern (NOC) for Svizera Labs Pvt Ltd Mumbai, India

The article discusses that EU and the U.S has EU has signed a mutual recognition agreement which allows complete assessments of each other’s inspection capabilities allowing eight regulatory authorities located in the EU and the FDA to review the outcomes of each other’s inspections.

The article discusses the Medical Dictionary for Regulatory Activities (MedDRA), which was developed by International Conference on Harmonisation (ICH) to assist sharing of regulatory information internationally and which has been successfully adopted as a worldwide standard for public health.

The article discusses a memorandum of understanding (MoU) signed by the Austrian Agency for Health and Food Safety (AGES) and the Swiss Agency for Therapeutic Products (Swissmedic) which focuses on strengthening collaboration.

The article discusses new rules announced by government department Health Canada which imposes stricter quality requirements for veterinary drugs in order to fight antimicrobial resistance.

The article discusses updates to the Australian orphan drug program announced by Therapeutic Goods Administration (TGA), wherein the program's eligibility and threshold criteria will be altered in order to qualify more conditions as orphan diseases.

The article presents an outline of the revised draft guidance text on good review practices for medical products that was endorsed by the Regulatory Harmonization Steering Committee (RHSC) of the Asia-Pacific Economic Cooperation (APEC) at its meeting in China in August 2014 for submission to World Health Organization (WHO). Indicated in the outline are the document objective, the principles of a good review, and managing the review.