The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.
Pharmacovigilance, also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: pharmakon and vigilare. As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction.
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.
The Veterinary Medicines Directorate (VMD) is an Executive Agency of the Department for Environment, Food and Rural Affairs (Defra) seeking to protect public health, animal health, the environment and promoting animal welfare by assuring the safety, quality and efficacy of veterinary medicines in the United Kingdom.
The Committee on Safety of Medicines (CSM) was an independent advisory committee that advised the UK Licensing Authority on the quality, efficacy, and safety of medicines.
The Council for International Organizations of Medical Sciences (CIOMS) is an international non-governmental organization of 40 international, national, and associate member groups representing the biomedical science community. It was jointly established by the World Health Organization (WHO) and United Nations Educational, Scientific and Cultural Organization (UNESCO) in 1949 as a successor to the International Medical Congress that organized 17 conferences from 1867 until the 1913 outbreak of World War One.
Veterinary pharmacovigilance in the United Kingdom is overseen by the Veterinary Medicines Directorate (VMD).
The Yellow Card Scheme is the United Kingdom's system for collecting information on suspected adverse drug reactions (ADRs) to medicines. The scheme allows the safety of the medicines and vaccines that are on the market to be monitored.
The Joint Committee on Vaccination and Immunisation (JCVI) is an independent expert advisory committee that advises United Kingdom health departments on immunisation, making recommendations concerning vaccination schedules and vaccine safety. It has a statutory role in England and Wales, and health departments in Scotland and Northern Ireland may choose to accept its advice.
The following outline is provided as an overview of and topical guide to clinical research:
In the European Union, the Qualified Person Responsible For Pharmacovigilance (QPPV) is an individual, usually an employee of a pharmaceutical company, who is personally responsible for the safety of the human pharmaceutical products marketed by that company in the EU. This function was established in 2004 by article 23 of regulation (EC) No 726/2004. The article establishes that the holder of a marketing authorization for a drug for human use must have a QPPV. When a company submits an application for permission to bring a medicinal product onto the market, the company submits a description of its system for monitoring the safety of the product in actual use and proof that the services of a QPPV are in place.
Professor Sir Munir Pirmohamed is a British clinical pharmacologist and geneticist. Since 2007 he has been the NHS Chair of Pharmacogenetics at the University of Liverpool.
Official Medicines Control Laboratory (OMCL) is the term coined in Europe for a public institute in charge of controlling the quality of medicines and, depending on the country, other similar products (for example, medical devices). They are part of or report to national competent authorities (NCAs).
Professor Jonathan Samuel Friedland is a British physician and medical researcher who is Deputy Vice-Chancellor and Professor of Infectious Diseases at St George's, University of London.
The Spanish Agency of Medicines and Medical Devices is a regulatory and autonomous agency of the Government of Spain that acts as the highest sanitary authority in the country in terms of medical safety on medicines, health products, cosmetics and personal care products.
A respiratory syncytial virus vaccine, or RSV vaccine, is a vaccine that protects against respiratory syncytial virus. RSV affects an estimated 64 million people and causes 160,000 deaths worldwide each year.
The Global Advisory Committee on Vaccine Safety (GACVS) is a group of experts that provides independent and authoritative guidance to the World Health Organization (WHO) on the topic of safe vaccine use.
Nirsevimab, sold under the brand name Beyfortus, is a human recombinant monoclonal antibody with activity against respiratory syncytial virus (RSV). It is a respiratory syncytial virus (RSV) F protein‑directed fusion inhibitor that is designed to bind to the fusion protein on the surface of the RSV virus.
