European Medicines Agency (EMA)

An European Medicines Agency (EMA) is an European Union's agency that is responsible for the evaluation of medicinal products.

• AKA: European Agency for the Evaluation of Medicinal Products, European Medicines Evaluation Agency (EMEA).
• Context:
  • Website: https://www.ema.europa.eu/en.
• Example(s):
  • EMA Regulated Clinical Trials,
  • EudraVigilance,
  • …
• Counter-Example(s):
  • Australia's Therapeutic Goods Administration,
  • Brazil's National Health Surveillance Agency,
  • Canada's Marketed Health Products Directorate,
  • Food Safety and Standards Authority of India,
  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH),
  • Japan's Pharmaceuticals and Medical Devices Agency,
  • Mexico's Federal Commission for the Protection against Sanitary Risk,
  • Philippines Food and Drug Administration (PFDA),
  • Singapore's Health Sciences Authority,
  • United Kingdom's Medicines and Healthcare products Regulatory Agency,
  • United States Food And Drug Administration (FDA).
• See: Medication, World Health Organization, Clinical Trial, Good Clinical Practice, COVID-19, Decentralization, Decentralized Clinical Trial.

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References

2022

• (EMA, 2022) ⇒ https://www.ema.europa.eu/en/about-us Retrieved: 2022-06-12.
  • QUOTE: The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU). It began operating in 1995. The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.

    EMA protects public and animal health in EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality.

    EMA serves a community of around 450 million people living in the EU.

2017

• (Wikipedia, 2017) ⇒ https://en.wikipedia.org/wiki/European_Medicines_Agency Retrieved:2017-11-26.
  • The European Medicines Agency (EMA) is a European Union agency for the evaluation of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products, but also European Medicines Evaluation Agency (EMEA). The EMA was set up in 1995 with funding from the European Union and the pharmaceutical industry, as well as indirect subsidy from member states, in an attempt to harmonise (but not replace) the work of existing national medicine regulatory bodies. The hope was that this plan would not only reduce the €350 million annual cost drug companies incurred by having to win separate approvals from each member state but also that it would eliminate the protectionist tendencies of sovereign states unwilling to approve new drugs that might compete with those already produced by domestic drug companies. The EU is currently the source of about one-third of the new drugs brought onto the world market each year. Based in London, the EMA was founded after more than seven years of negotiations among EU governments and replaced the Committee for Proprietary Medicinal Products and the Committee for Veterinary Medicinal Products, though both of these were reborn as the core scientific advisory committees. After the United Kingdom withdrawal from the European Union referendum the agency will relocate to Amsterdam.

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