This manual is intended to provide clear operational guidance on the benchmarking of regulatory systems for medical products and the development of institutional development plans (IDPs) to address areas for improvement. The manual is integral to the World Health Organization’s structured and evidence-based approach to regulatory systems strengthening (RSS), mandated by World Health Assembly resolution WHA 67.20. The manual serves to ensure a proper understanding of the Global Benchmarking Tool (GBT); the processes and principles that govern its use; the expectations of individuals and institutions involved; and the information management systems that underpin the collection, analysis and management of data and the generation of knowledge.

The 76th meeting of the WHO Expert Committee on Biological Standardization was held from 24 to 28 October 2023 by Zoom video conferencing. The meeting was opened on behalf of the Director-General of WHO by Dr Clive Ondari, Director, Health Products Policy and Standards. The Expert Committee on Biological Standardization reviews developments in the field of biological substances used in human medicine, which include vaccines, biotherapeutics, blood products and related substances, and in vitro diagnostic reagents. It coordinates activities leading to: (a) the adoption of WHO guidelines and recommendations for assuring the quality, safety and efficacy of such substances; and (b) the establishment of WHO international standards and other reference materials. The use of international reference materials for designating the activity of biological substances used in prophylaxis or therapy, or for ensuring the reliability of quality control or diagnostic procedures, allows for the comparison of data worldwide. Target audience includes - but is not limited to - regulators, manufacturers, policymakers, health workers, developers of vaccines and other biological products and academia.

This manual provides operational and technical details for the performance evaluation (PE) exercise that must be conducted for a regulatory authority (RA) to achieve listing as a WHO-listed authority (WLA) in relation to each regulatory function. The PE manual should be read in conjunction with the Operational guidance for evaluating and publicly designating regulatory authorities as WHO-listed authorities (“The Operational Guidance”). For the purposes of this document the term regulatory authority (RA), unless otherwise stated, may refer to either a national regulatory authority (NRA) or a regional regulatory system (RRS). The basis for designation as a WLA is provided by the Global Benchmarking Tool (GBT), which is complemented by a series of PE activities designed to establish a detailed picture of how the regulatory system performs on relevant regulatory processes, including how consistently it adheres to quality procedures and how well it delivers the desired regulatory outputs in accordance with good regulatory practices.

The Global competency framework for regulators of medicines provides a framework for best practices and general considerations aimed at harmonizing workforce development efforts for the regulation of medicines by establishing an internationally accepted set of organizational and role-specific competencies.

The Operational guidance for evaluating and publicly designating regulatory authorities as WHO-listed authorities provide procedural information (processes, steps and timelines) and general considerations related to the evaluation and listing of a regulatory authority as a WHO-listed authority (WLA). The guidance also describes the process and criteria for renewal, re-evaluation and possible delisting, the role and responsibilities of the technical advisory group on WLAs (TAG-WLA) and the undertakings of WHO and eligible regulatory authorities.

From the latest vaccination evidence, recommendations, and protocols . . . to new vaccine development and the use of vaccines in reducing disease, Plotkin's Vaccines, 8th Edition, covers every aspect of vaccination. Now completely revised and updated from cover to cover, this award-winning text continues to provide reliable information from global authorities, offering a complete understanding of each disease, as well as the latest knowledge of both existing vaccines and those currently in research and development. Described by Bill Gates as "an indispensable guide to the enhancement of the well-being of our world," Plotkin's Vaccines is a must-have reference for current, authoritative information in this fast-moving field. - Contains all-new chapters on COVID-19, vaccine hesitancy, and non-specific effects of vaccines, as well as significantly revised content on new vaccine technologies such as mRNA vaccines, emerging vaccines, and technologies to improve immunization. - Presents exciting new data on evolution of adjuvants across the centuries, dengue vaccines, human papillomavirus vaccines, respiratory syncytial virus vaccines, tuberculosis vaccines, and zoster vaccines. - Provides up-to-date, authoritative information on vaccine production, available preparations, efficacy and safety, and recommendations for vaccine use, with rationales and data on the impact of vaccination programs on morbidity and mortality. - Provides complete coverage of each disease, including clinical characteristics, microbiology, pathogenesis, diagnosis, and treatment, as well as epidemiology and public health and regulatory issues. - Keeps you up to date with information on each vaccine, including its stability, immunogenicity, efficacy, duration of immunity, adverse events, indications, contraindications, precautions, administration with other vaccines, and disease-control strategies. - Covers vaccine-preventable diseases, vaccine science, and licensed vaccine products, as well as product technologies and global regulatory and public health issues. - Analyzes the cost-benefit and cost-effectiveness of different vaccine options. - Helps you clearly visualize concepts and objective data through an abundance of tables and figures. - Enhanced eBook version included with purchase. Your enhanced eBook allows you to access all of the text, figures, and references from the book on a variety of devices.

Ensuring the safety of food and the quality and safety of medicines in a country is an important role of government, made more complicated by global manufacturing and international trade. By recent estimates, unsafe food kills over 400,000 people a year, a third of them children under 5, mostly in low- and middle-income countries; every year poor quality medicines cause about 70,000 excess deaths from childhood pneumonia and roughly 8,500 to 20,000 malaria deaths in sub-Saharan Africa alone. The Federal Drug Administration (FDA) Office of Global Policy and Strategy is charged with improving capacity of the agency's foreign counterpart offices and increasing understanding of the importance of regulatory systems for public health, development, and trade. At the request of the FDA, this study sets out a strategy to support good quality, wholesome food and safe, effective medical products around the world. Its goal is to build on the momentum for strengthening regulatory systems and to set a course for sustainability and continued progress. The 2012 report Ensuring Safe Food and Medical Products Through Stronger Regulatory Systems Abroad outlined strategies to secure international supply chains, emphasized capacity building and support for surveillance in low- and middle-income countries, and explored ways to facilitate work sharing among food and medical product regulatory agencies. This new study assess progress made and the current regulatory landscape.

This encyclopedia covers the definitions, concepts, methods, theories, and application of evidence-based pharmaceutical public health and health services research. It highlights why and how this field has a significant impact on healthcare. The work aims to synthesize baseline knowledge as well as the latest and cutting-edge research-based information. The encyclopedia collates information on public health, health services research, evidence-based pharmacy practice and its impacts on patients, decision-makers and consumers. This reference work discusses all aspects of policy and practice decisions on medicines use, access and pharmacy services by covering broad aspects related to pharmacy practice, public health and health services research. The aim is to develop high-quality content, which will be a must-read and be used as a reference source at all pharmacy and medical schools in the world. The health services research investigates the impact of social factors, organizational policies, financing systems, medical technologies and personal influence on access, quality and cost of healthcare concerning the quality of life of the patients. This reference work fundamentally promotes the evidence-based evaluation of healthcare services and thus will improve the better access and delivery of healthcare services. Also, pharmacy, medical and health services students and researchers need a broad understanding of pharmaceutical public health, evidence-based approaches to delivering care, changing professional and patient behavior and undertaking research in these areas. In general, there is a need to build research capacity and capability in the pharmacy profession. EDITOR-IN-CHIEF: Professor Zaheer-Ud-Din Babar, University of Huddersfield SECTION EDITORS: Filipa Alves da Costa, University of LisbonZubin Austin, University of TorontoDalia Dawood, National Institute for Health and Care Excellence Andy Gray, University of Kwa Zulu-NatalRachele Hendricks-Sturrup, Duke Margolis Center for Health PolicyJason Hsu, Taiwan Medical UniversityRabia Hussain, Universiti Sains MalaysiaChristine Y. Lu, Harvard Medical School and Harvard Pilgrim Health Care InstituteMohamed Izham Mohamed Ibrahim, Qatar UniversityPrasad Nishtala, University of BathDerek Charles Stewart, College of Pharmacy, Qatar University Fatima Suleman, University of Kwa Zulu-NatalZaheer-Ud-Din Babar, University of Huddersfield