View source for European Medicines Agency

{{short description|Agency of the European Union}}
{{distinguish|European Directorate for the Quality of Medicines & HealthCare}}
{{More citations needed|date=December 2022}}
{{Use British English|date=March 2013}}
{{Use dmy dates|date=October 2020}}
{{Infobox government agency
| agency_name     = European Medicines Agency
| type            =
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| logo            = European Medicines Agency.svg
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| picture         = Vivaldigebouw 2019.10.24 (1).jpg
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| picture_caption = EMA headquarters in Amsterdam
| formed          = {{Start date and age|1995|01|01|df=y}}
| preceding1      =
| preceding2      = <!-- (etc.) -->
| dissolved       =
| superseding     =
| jurisdiction    = [[European Union]]
| headquarters    = [[Amsterdam]], Netherlands<ref name="Relocation">{{cite web | title=Relocation to Amsterdam | website=European Medicines Agency | date=17 September 2018 | url=https://www.ema.europa.eu/en/about-us/uks-withdrawal-eu/relocation-amsterdam | access-date=16 January 2021 | archive-date=15 October 2019 | archive-url=https://web.archive.org/web/20191015190709/https://www.ema.europa.eu/en/about-us/uks-withdrawal-eu/relocation-amsterdam | url-status=live }}</ref>
| coordinates     = <!--{{coord|LATITUDE|LONGITUDE|type:landmark_region:US|display=inline,title}}-->
| motto           = Science. Medicines. Health.
| employees       = 897<ref>{{Cite web|url=https://europa.eu/european-union/about-eu/agencies/ema_en|title=European Medicines Agency (EMA) {{!}} European Union|date=26 February 2020|website=europa.eu|access-date=26 February 2020|archive-date=8 April 2019|archive-url=https://web.archive.org/web/20190408104634/https://europa.eu/european-union/about-eu/agencies/ema_en|url-status=live}}</ref>
| budget          = €478.4{{nbsp}}million (2024)<ref>{{Cite web|url=https://www.ema.europa.eu/en/documents/other/european-medicines-agency-budget-2024_en.pdf|title=Funding {{!}} European Medicines Agency (EMA)|date=8 January 2024|website=European Medicines Agency|access-date=26 March 2024|archive-date=26 March 2024|archive-url=https://web.archive.org/web/20240326091934/https://www.ema.europa.eu/en/documents/other/european-medicines-agency-budget-2024_en.pdf|url-status=live}}</ref>
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| deputyminister1_name =
| deputyminister1_pfo =
| deputyminister2_name =
| deputyminister2_pfo = <!-- (etc.) -->
| chief1_name     = [[Emer Cooke]]
| chief1_position = Executive Director
| chief2_name     = Christa Wirthumer-Hoche
| chief2_position = Chairperson
<!-- (etc.) -->| director_general =
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| keydocument1    = [http://eur-lex.europa.eu/legal-content/EN/AUTO/?uri=celex:32004R0726 Regulation (EC) No. 726/2004]
<!-- (etc.) -->| website         = {{URL|http://ema.europa.eu/}}
| footnotes       =
| map             = {{Location map many  | European Union
 | width         = 250px
 | label1        = Amsterdam
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 | position1     = right
 | coordinates1  = {{coord|52.33|4.88}}}}
| map_width       = 275
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}}

{{Politics of the European Union}}
The '''European Medicines Agency''' ('''EMA''') is an [[Agencies of the European Union|agency of the European Union]] (EU) in charge of the evaluation and supervision of [[Medication|pharmaceutical products]]. Prior to 2004, it was known as the '''European Agency for the Evaluation of Medicinal Products''' ('''EAEMP''') or '''European Medicines Evaluation Agency''' ('''EMEA''').<ref name="auto4">Set up by EC Regulation No. 2309/93 as the European Agency for the Evaluation of Medicinal Products, and renamed by EC Regulation No. 726/2004 to the European Medicines Agency, it had the acronym EMEA until December 2009. The European Medicines Agency does not call itself EMA either – it has no official acronym but may reconsider if EMA becomes commonly accepted (see [http://www.ema.europa.eu/pdfs/general/direct/74766509en.pdf communication on new visual identity] {{webarchive|url=https://web.archive.org/web/20100601053816/http://www.ema.europa.eu/pdfs/general/direct/74766509en.pdf |date=1 June 2010 }} and [http://www.ema.europa.eu/htms/general/direct/visual_identity.htm logo] {{webarchive|url=https://web.archive.org/web/20091225201855/http://www.ema.europa.eu/htms/general/direct/visual_identity.htm |date=25 December 2009 }}).</ref><ref name="auto1">{{Cite web|url=http://www.pmlive.com/pharma_news/emea_becomes_ema_197492|title=EMEA becomes EMA|date=14 December 2009|website=PMLive|access-date=6 October 2017|archive-date=22 November 2022|archive-url=https://web.archive.org/web/20221122132955/https://www.pmlive.com/pharma_news/emea_becomes_ema_197492|url-status=dead}}</ref>

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, its stated intention to harmonise (but not replace) the work of existing national [[Medication|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 [[protectionism|protectionist]] tendencies of [[sovereign state]]s unwilling to approve new drugs that might compete with those already produced by domestic drug companies.

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. The agency was located in [[London]] prior to the [[Brexit|United Kingdom's vote for withdrawal from the European Union]], relocating to [[Amsterdam]] in March 2019.<ref name="auto3">{{Cite web|url=https://www.ema.europa.eu/en/news/ema-now-operating-amsterdam|title=EMA now operating from Amsterdam|last=Hrabovszki|first=Georgina|date=2019-03-11|website=European Medicines Agency|access-date=2019-03-12|archive-date=16 October 2019|archive-url=https://web.archive.org/web/20191016015945/https://www.ema.europa.eu/en/news/ema-now-operating-amsterdam|url-status=live}}</ref><ref name="auto2">{{cite web | title=United Kingdom's withdrawal from the European Union ('Brexit') | website=European Medicines Agency | date=17 September 2018 | url=https://www.ema.europa.eu/en/about-us/united-kingdoms-withdrawal-european-union-brexit | access-date=16 September 2019 | archive-date=15 September 2019 | archive-url=https://web.archive.org/web/20190915124820/https://www.ema.europa.eu/en/about-us/united-kingdoms-withdrawal-european-union-brexit | url-status=live }}</ref>

==Operations==
The European Medicines Agency (EMA) operates as a decentralised scientific [[Agencies of the European Union|agency]] (as opposed to a [[regulatory authorities|regulatory authority]]) of the [[European Union]] (EU) and its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.<ref>{{cite book|url=https://www.taylorfrancis.com/chapters/edit/10.1081/E-EPT4-120050267/european-medicines-agency-ema-david-jacobs|title=Encyclopedia of Pharmaceutical Science and Technology|chapter=European Medicines Agency (EMA)|first=David|last=M. Jacobs|edition=4|year=2015|pages=1449–1460|doi=10.1081/E-EPT4-120050267|isbn=9781351124874|access-date=26 December 2022|archive-date=26 December 2022|archive-url=https://web.archive.org/web/20221226093617/https://www.taylorfrancis.com/chapters/edit/10.1081/E-EPT4-120050267/european-medicines-agency-ema-david-jacobs|url-status=live}}</ref> More specifically, it coordinates the evaluation and monitoring of centrally authorised products and national referrals, develops technical guidance and provides scientific advice to sponsors. Its scope of operations is medicinal products for human and veterinary use including biologics and advanced therapies, and [[herbal medicine|herbal medicinal products]]. The agency is composed of the [[Secretariat (administrative office)|Secretariat]] (ca. 600 staff), a management board, seven scientific committees (human, veterinary and herbal medicinal products, [[orphan drug]]s, paediatrics, advanced therapies and [[pharmacovigilance]] risk assessment) and a number of scientific working parties.

The Secretariat is organised into five units: Directorate, Human Medicines Development and Evaluation, Patient Health Protection, Veterinary Medicines and Product Data Management, Information and Communications Technology and Administration. The management board provides administrative oversight to the Agency: including approval of budgets and plans, and selection of [[executive director]]. The Board includes one representative of each of the 27 Member States, two representatives of the [[European Commission]], two representatives of the [[European Parliament]], two representatives of patients' organisations, one representative of doctors' organisations and one representative of veterinarians' organisations. The Agency [[decentralization|decentralises]] its scientific assessment of medicines by working through a network of about 4500 experts throughout the EU. The EMA draws on resources of over 40 National Competent Authorities (NCAs) of EU Member states.

The EMA additionally engages with international agencies and non-governmental organizations on areas of mutual interest, such as its participation on the [[Coalition for Epidemic Preparedness Innovations]]' Joint Coordination Group.<ref>{{Cite web |title=Who we are |url=https://cepi.net/about/whoweare/ |url-status=live |archive-url=https://web.archive.org/web/20221019165747/https://cepi.net/about/whoweare/ |archive-date=2022-10-19 |access-date=2023-09-16 |website=[[Coalition for Epidemic Preparedness Innovations]] |language=en-US}}</ref> It is also a benefactor of [[Health Level Seven International]],<ref>{{Cite web |title=Benefactors of Health Level Seven |url=http://www.hl7.org/about/benefactors.cfm |url-status=live |archive-url=https://web.archive.org/web/20230601080537/http://www.hl7.org/about/benefactors.cfm |archive-date=2023-06-01 |access-date=2023-09-17 |website=[[Health Level Seven International]]}}</ref> a member of the [[International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use]]<ref>{{Cite web |title=Members & Observers |url=https://www.ich.org/page/members-observers |url-status=live |archive-url=https://archive.today/20220424053337/https://www.ich.org/page/members-observers |archive-date=2022-04-24 |access-date=2023-09-17 |website=[[International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use]]}}</ref> and the International Pharmaceutical Regulators Programme (IPRP),<ref>{{Cite web |title=Members & Observers |url=https://www.iprp.global/members |url-status=live |archive-url=https://archive.today/20220424064614/https://www.iprp.global/members |archive-date=2022-04-24 |access-date=2023-09-17 |website=International Pharmaceutical Regulators Programme}}</ref> and a partner of the [[Society for Immunotherapy of Cancer]]<ref>{{Cite web |title=Cancer Immunotherapy Partnerships and Collaborations |url=https://www.sitcancer.org/aboutsitc/partnerships |url-status=live |archive-url=https://web.archive.org/web/20230327191240/https://www.sitcancer.org/aboutsitc/partnerships#champions |archive-date=2023-03-27 |access-date=2023-09-17 |website=[[Society for Immunotherapy of Cancer]] |language=en}}</ref> and [[Vaccine Confidence Project]].<ref>{{Cite web |title=Partnerships |url=https://www.vaccineconfidence.org/who-we-are/partnerships/ |url-status=deviated |archive-url=https://web.archive.org/web/20220428122506/https://www.vaccineconfidence.org/partners-funders |archive-date=2022-04-28 |access-date=2023-09-17 |website=[[Vaccine Confidence Project]] |language=en-GB}}</ref>

===Committees===
====Medicinal products for human use====
A single evaluation is carried out through the [[Committee for Medicinal Products for Human Use]] (CHMP).<ref>{{cite web | title=Committee for Medicinal Products Human Use (CHMP) | website=European Medicines Agency (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/committees/committee-medicinal-products-human-use-chmp | access-date=26 July 2020 | archive-date=15 August 2022 | archive-url=https://web.archive.org/web/20220815132841/https://www.ema.europa.eu/en/committees/committee-medicinal-products-human-use-chmp | url-status=live }}</ref> If the Committee concludes that the quality, safety and efficacy of the medicinal product is sufficiently proven, it adopts a positive opinion. This is sent to the [[European Commission]] to be transformed into a marketing authorisation valid for the whole of the EU. A special type of approval is the [[paediatric-use marketing authorisation]] (PUMA), which can be granted for medical products intended exclusively for paediatric use.<ref>{{cite web|url=http://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/09/WC500112071.pdf|title=Questions and answers on the paediatric use marketing authorisation (PUMA)|publisher=European Medicines Agency (EMA) |date=13 September 2011 |url-status=dead|archive-url=https://web.archive.org/web/20160415043930/http://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/09/WC500112071.pdf|archive-date=2016-04-15}}</ref>

The CHMP is obliged by the regulation to reach decisions within 210 days, though the clock is stopped if it is necessary to ask the applicant for clarification or further supporting data.<ref>{{cite web|url=https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/evaluation-medicines-step-step|title=The evaluation of medicines, step-by-step|publisher=European Medicines Agency (EMA)|date=25 November 2023|access-date=25 November 2023|archive-date=25 November 2023|archive-url=https://web.archive.org/web/20231125151506/https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/evaluation-medicines-step-step|url-status=live}}</ref>

The review process of the European Medicines Agency regarding medical issues has been criticized for its lack of transparency.<ref>{{Cite web |last= |first= |date=2017 |title=Complaint filed to the European Medicines Agency over maladministration related to safety of the HPV vaccines |url=https://nordic.cochrane.org/news/complaint-filed-european-medicines-agency-over-maladministration-related-safety-hpv-vaccines |url-status=dead |archive-url=https://web.archive.org/web/20170831050958/https://nordic.cochrane.org/news/complaint-filed-european-medicines-agency-over-maladministration-related-safety-hpv-vaccines |archive-date=31 August 2017 |access-date=16 January 2021 |website=Cochrane Nordic}}</ref> In a rebuttal of an EMS review that included her work, Louise Brinth, a Danish physician, noted that "experts" reviewing data remain unnamed and seem to be bound to secrecy. Minutes are not released and diverging opinions are not reported suggesting that all the "experts" are of the same opinion. In her view the process is unscientific and undemocratic.<ref>Louise Brinth: ''Responsum to Assessment Report on HPV-vaccines released by EMA November 26th 2015.'', [http://www.ft.dk/samling/20151/almdel/suu/bilag/109/1581470.pdf online] (PDF; 1,3&nbsp;MB) {{webarchive|url=https://web.archive.org/web/20160707140043/http://www.ft.dk/samling/20151/almdel/suu/bilag/109/1581470.pdf|date=7 July 2016}}</ref>

====Medicinal products for veterinary use====
The [[Committee for Medicinal Products for Veterinary Use]] (CVMP) operates in analogy to the CHMP as described above.<ref>{{cite web | title=Committee for Medicinal Products Veterinary Use (CVMP) | website=European Medicines Agency (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/committees/committee-medicinal-products-veterinary-use-cvmp | access-date=26 July 2020 | archive-date=27 May 2021 | archive-url=https://web.archive.org/web/20210527161617/https://www.ema.europa.eu/en/committees/committee-medicinal-products-veterinary-use-cvmp | url-status=dead }}</ref>

====Orphan medicinal products====
The [[Committee on Orphan Medicinal Products]] (COMP) administers the granting of [[orphan drug]] status since 2000. Companies intending to develop medicinal products for the diagnosis, prevention or treatment of life-threatening or very serious conditions that affect not more than five in 10,000 persons in the European Union can apply for 'orphan medicinal product designation'. The COMP evaluates the application and makes a recommendation for the designation which is then granted by the [[European Commission]].<ref>{{cite web|url=https://www.ema.europa.eu/en/human-regulatory/overview/orphan-designation-overview|title=Orphan designation: Overview|date=17 September 2018|publisher=European Medicines Agency|access-date=26 December 2022|archive-date=26 December 2022|archive-url=https://web.archive.org/web/20221226092721/https://www.ema.europa.eu/en/human-regulatory/overview/orphan-designation-overview|url-status=live}}</ref>

====Herbal medicinal products====
The [[Committee on Herbal Medicinal Products]] (HMPC) assists the [[Directive 2001/83/EC|harmonisation]] of procedures and provisions concerning herbal medicinal products laid down in EU Member States, and further [[European Directive on Traditional Herbal Medicinal Products|integrating herbal medicinal products in the European regulatory framework]] since 2004.<ref>{{cite web|url=https://www.ema.europa.eu/en/human-regulatory/herbal-medicinal-products|title=Herbal medicinal products|date=17 September 2018|publisher=European Medicines Agency (EMA)|access-date=26 December 2022|archive-date=30 June 2018|archive-url=https://web.archive.org/web/20180630052949/http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000208.jsp&mid=WC0b01ac05800240cf|url-status=live}}</ref>

====Paediatry====
The Paediatric Committee (PDCO) deals with the implementation of the paediatric legislation in Europe Regulation (EC) No 1901/2006 since 2007. Under this legislation, all applications for [[European Pharmaceutical Regulation|marketing authorisation]] of new medicinal products, or variations to existing authorisations, have to either include data from paediatric studies previously agreed with the PDCO, or obtain a PDCO waiver or a deferral of these studies.<ref>{{cite web|url=https://www.ema.europa.eu/en/human-regulatory/overview/paediatric-medicines/paediatric-regulation|title=Paediatric Regulation|date=17 September 2018|publisher=European Medicines Agency (EMA)|access-date=26 December 2022|archive-date=26 December 2022|archive-url=https://web.archive.org/web/20221226093021/https://www.ema.europa.eu/en/human-regulatory/overview/paediatric-medicines/paediatric-regulation|url-status=live}}</ref>

====Advanced therapies====
The [[Committee for Advanced Therapies]] (CAT) was established in accordance with Regulation (EC) No 1394/2007 on advanced-therapy medicinal products (ATMPs) such as [[gene therapy]], [[somatic cell]] therapy and [[tissue engineering|tissue engineered]] products. It assesses the quality, safety and efficacy of ATMPs, and follows scientific developments in the field.<ref>{{Cite web|url=https://www.ema.europa.eu/en/committees/committee-advanced-therapies-cat|title=Committee for Advanced Therapies (CAT)|last=European Medicines Agency|date=3 December 2019|website=European Medicines Agency|access-date=3 December 2019|archive-date=10 December 2019|archive-url=https://web.archive.org/web/20191210061944/https://www.ema.europa.eu/en/committees/committee-advanced-therapies-cat|url-status=live}}</ref>

====Pharmacovigilance risk assessment====
{{anchor|PRAC}}
A seventh committee, the Pharmacovigilance Risk Assessment Committee (PRAC) has come into function in 2012 with the implementation of the new EU pharmacovigilance legislation (Directive 2010/84/EU).<ref>{{Cite web|url=https://www.ema.europa.eu/en/committees/pharmacovigilance-risk-assessment-committee-prac|title=Pharmacovigilance Risk Assessment Committee (PRAC)|last=European Medicines Agency|date=3 December 2019|website=European Medicines Agency|access-date=3 December 2019|archive-date=11 October 2021|archive-url=https://web.archive.org/web/20211011182251/https://www.ema.europa.eu/en/committees/pharmacovigilance-risk-assessment-committee-prac|url-status=live}}</ref>

===Other activities===
The Agency carries out a number of activities, including:
* '''[[Pharmacovigilance]]''': The Agency constantly monitors the safety of medicines through a pharmacovigilance network and [[EudraVigilance]], so that it can take appropriate actions if adverse drug reaction reports suggest that the benefit-risk balance of a medicine has changed since it was authorised.
* '''Referrals''': The Agency coordinates arbitration procedures relating to medicinal products that are approved or under consideration by Member States in non-centralized authorisation procedures.
* '''Scientific Advice''': Companies wishing to receive scientific advice from the CHMP or CVMP on the appropriate tests and studies to carry out in the development of a medicinal products can request it prior to or during the development program.
* '''Telematics projects''': The Agency is responsible for implementing a central set of pan-European systems and databases such as EudraVigilance, [[EudraCT]] and [[EudraPharm]].

===Centralised marketing authorisations===
The centralised procedure allows companies to submit a single application to the agency to obtain from the European Commission a centralised (or "community") marketing authorisation (MA) valid in all [[European Union#Member states|European Union member states]] and in [[Iceland]], [[Liechtenstein]] and [[Norway]].<ref name="EU Marketing authorisation">{{cite web | title=Marketing authorisation | website=European Medicines Agency | date=17 September 2018 | url=https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation | access-date=23 March 2021 | archive-date=3 May 2021 | archive-url=https://web.archive.org/web/20210503201621/https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation | url-status=live }}</ref> The centralised procedure is compulsory for all medicines derived from biotechnology and other high-tech processes, as well as for human medicines for the treatment of HIV/AIDS, cancer, diabetes, neurodegenerative diseases, auto-immune and other immune dysfunctions, and viral diseases, and for veterinary medicines for use for growth or yield enhancers. It is also compulsory for advanced-therapy medicines such as gene-therapy, somatic cell-therapy or tissue-engineered medicines and for [[orphan medicine]]s (for rare diseases). The centralised procedure is also open to products that bring a significant therapeutic, scientific or technical innovation, or is in any other respect in the interest of patient or animal health. As a result, the majority of genuinely novel medicines are authorised through the EMA.

For products eligible for or requiring centralised approval, a company submits an application for a marketing authorisation to the EMA.

==History==
===1995-2004: Inception===
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, its stated intention to harmonise (but not replace) the work of existing national [[Medication|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 [[protectionism|protectionist]] tendencies of [[Sovereign state]]s unwilling to approve new drugs that might compete with those already produced by domestic drug companies.{{Citation needed|date=August 2022}}

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. The agency was located in [[London]] prior to the [[Brexit|United Kingdom's vote for withdrawal from the European Union]], relocating to [[Amsterdam]] in March 2019.<ref name="auto3"/><ref name="auto2"/>

===2004: Renaming===
Prior to 2004, it was known as the '''European Agency for the Evaluation of Medicinal Products''' or '''European Medicines Evaluation Agency''' ('''EMEA''').<ref name="auto4"/><ref name="auto1"/>

The EMA contributed to the Global Vaccine Action Plan developed by the Decade of Vaccines Collaboration, endorsed by the 194 Member States of the [[World Health Assembly]] in May 2012, and published on the [[World Health Organization]]'s website in February 2013.<ref>{{Cite web |title=Annex 5: Countries and Organizations that Contributed to the Elaboration of the GVAP |url=https://cdn.who.int/media/docs/default-source/vaccines-and-immunization/gvap-annex5.pdf |url-status=live |archive-url=https://web.archive.org/web/20230917173603/https://cdn.who.int/media/docs/default-source/vaccines-and-immunization/gvap-annex5.pdf |archive-date=2023-09-17 |access-date=2023-09-17 |website=[[World Health Organization]] |publisher=Decade of Vaccines Collaboration}}</ref>

===2019: Relocation===
Following the 2016 decision of the [[United Kingdom]] to leave the European Union ("[[Brexit]]"), the EMA chose to search for another base of operations. According to EU Law the [[European Commission]] had to decide on the fate of the EMA's location. The EU ministers met to vote on their preferred successor.<ref name="EU Agencies Relocation">{{Cite web|url=https://www.consilium.europa.eu/en/policies/relocation-london-agencies-brexit/ema/|title=Offers to host the European Medicines Agency (EMA)|publisher=European Council|access-date=14 September 2017|archive-date=13 December 2017|archive-url=https://web.archive.org/web/20171213095147/https://www.consilium.europa.eu/en/policies/relocation-london-agencies-brexit/ema/|url-status=live}}</ref> The EU's Health Commissioner [[Vytenis Andriukaitis]] said that the preferred choice would be a location where an "easy set up and guarantee of smooth operations" would be available. All the remaining EU member states except for the Baltic States and Luxembourg submitted proposals to host the agency.<ref name="ReutersUKlink">{{Cite news|url=http://uk.reuters.com/article/uk-britain-eu-pharmaceuticals-ema-idUKKBN17C12X|title=Reuters – Twenty-one countries vie to host EU drug agency after Brexit|newspaper=Reuters|date=10 April 2017|access-date=10 August 2017|archive-date=11 August 2017|archive-url=https://web.archive.org/web/20170811055300/http://uk.reuters.com/article/uk-britain-eu-pharmaceuticals-ema-idUKKBN17C12X|url-status=dead}}</ref><ref name="EUcouncillink">{{Cite web|url=http://www.consilium.europa.eu/en/policies/relocation-uk-based-agencies/ema/|title=Offers to host the European Medicines Agency (EMA)|publisher=European Council|access-date=10 August 2017|archive-date=6 August 2017|archive-url=https://web.archive.org/web/20170806160820/http://www.consilium.europa.eu/en/policies/relocation-uk-based-agencies/ema/|url-status=dead}}</ref><ref>{{Cite web|url=https://stm.fi/en/-/ministeri-mattila-suomi-on-hyva-paikka-euroopan-laakevirastolle|title=Finland is an excellent place for European Medicines Agency|publisher=[[Ministry of Social Affairs and Health]]|language=en-US|date=12 April 2017|access-date=18 April 2017|archive-date=18 April 2021|archive-url=https://web.archive.org/web/20210418183915/https://stm.fi/en/-/ministeri-mattila-suomi-on-hyva-paikka-euroopan-laakevirastolle|url-status=live}}</ref><ref>{{cite web|first=Patrick|last=Wintour|url=https://www.theguardian.com/world/2017/feb/15/countries-host-european-medicines-agency-leaves-uk-post-brexit/|title=Countries line up to host European Medicines Agency after it leaves UK|work=The Guardian|date=15 February 2017|access-date=1 April 2017|archive-date=1 April 2017|archive-url=https://web.archive.org/web/20170401233343/https://www.theguardian.com/world/2017/feb/15/countries-host-european-medicines-agency-leaves-uk-post-brexit|url-status=live}}</ref><ref>{{Cite web|url=http://www.netherlandsforema.eu/|title=Homepage – The Dutch Bid for EMA|website=The Dutch Bid for EMA|language=en-us|access-date=13 July 2017|archive-url=https://web.archive.org/web/20170714060448/http://www.netherlandsforema.eu/|archive-date=14 July 2017|url-status=dead}}</ref><ref>{{Cite web|url=https://www.theguardian.com/world/2017/feb/15/countries-host-european-medicines-agency-leaves-uk-post-brexit|title=Countries line up to host European Medicines Agency after it leaves UK|website=[[The Guardian]]|first=Patrick|last=Wintour|language=en|date=15 February 2017|access-date=8 May 2017|archive-date=29 April 2017|archive-url=https://web.archive.org/web/20170429212229/https://www.theguardian.com/world/2017/feb/15/countries-host-european-medicines-agency-leaves-uk-post-brexit|url-status=live}}</ref><ref>{{Cite news|url=http://www.euractiv.com/section/uk-europe/news/romania-looks-to-poach-eu-medicines-agency-from-uk/|title=Romania looks to poach EU medicines agency from UK|publisher=Euractiv|first=Sam|last=Morgan|language=en|date=23 March 2017|access-date=8 May 2017|archive-date=30 April 2017|archive-url=https://web.archive.org/web/20170430060022/http://www.euractiv.com/section/uk-europe/news/romania-looks-to-poach-eu-medicines-agency-from-uk|url-status=live}}</ref><ref>{{Cite news|url=https://www.global-counsel.co.uk/blog/brexit-pill-romania|title=A Brexit pill for Romania|language=en|publisher=Global Counsel UK|date=13 April 2017|access-date=8 May 2017|archive-date=11 August 2017|archive-url=https://web.archive.org/web/20170811060124/https://www.global-counsel.co.uk/blog/brexit-pill-romania|url-status=live}}</ref><ref>{{cite news|author=Julia Bradshaw |url=https://www.telegraph.co.uk/business/2016/12/08/sweden-launches-campaign-host-eu-drugs-agency-instead-uk-brexit/ |archive-url=https://ghostarchive.org/archive/20220112/https://www.telegraph.co.uk/business/2016/12/08/sweden-launches-campaign-host-eu-drugs-agency-instead-uk-brexit/ |archive-date=12 January 2022 |url-access=subscription |url-status=live |title=Sweden launches campaign to host EU drugs agency instead of UK after Brexit |work=The Telegraph|date=8 December 2016 |access-date=1 April 2017}}{{cbignore}}</ref><ref>{{cite web |first=Andreja |last=Zapcic |url=https://www.tportal.hr/vijesti/clanak/kujundzic-hrvatska-je-spremna-preuzeti-europsku-agenciju-za-lijekove-20170329/ |title=Kujundžić: Hrvatska je spremna preuzeti Europsku agenciju za lijekove |publisher=T-portal |trans-title=Kujundžić: Croatia Is Ready to Take Over the European Medicines Agency |date=29 March 2017 |access-date=1 April 2017 |language=hr |archive-date=29 March 2017 |archive-url=https://web.archive.org/web/20170329141020/https://www.tportal.hr/vijesti/clanak/kujundzic-hrvatska-je-spremna-preuzeti-europsku-agenciju-za-lijekove-20170329 |url-status=live }}</ref>

It had also been speculated that the [[Strasbourg]]-based seat for the [[European Parliament]] could be moved to Brussels, in exchange for the city to host the EMA.<ref>{{Cite web|url=https://www.euractiv.com/section/politics/news/strasbourg-could-trade-parliament-seat-for-medicines-agency/|title=Strasbourg could trade Parliament seat for medicines agency|publisher=Reuters|via=Euractiv|date=10 May 2017|access-date=26 December 2022|archive-date=22 November 2022|archive-url=https://web.archive.org/web/20221122131021/https://www.euractiv.com/section/politics/news/strasbourg-could-trade-parliament-seat-for-medicines-agency/|url-status=live}}</ref> Others speculated on the merits of Amsterdam, well before the final decision was made.<ref>{{cite news|title=EMA staff favour move to Amsterdam|url=http://www.pharmatimes.com/news/ema_staff_favour_move_to_amsterdam_1206474|first=George|last=Underwood|work=Pharma Times|date=27 September 2017|access-date=19 October 2017|archive-date=5 October 2017|archive-url=https://web.archive.org/web/20171005021003/http://www.pharmatimes.com/news/ema_staff_favour_move_to_amsterdam_1206474|url-status=live}}</ref><ref name="auto">{{cite news|title=European drug regulation at risk of stalling as agency prepares to leave London.|url=https://www.nature.com/articles/nature.2017.22817|work=[[Nature News]]|first=Inga|last=Vesper|date=12 October 2017|access-date=13 October 2017|archive-date=17 May 2022|archive-url=https://web.archive.org/web/20220517031019/https://www.nature.com/articles/nature.2017.22817|url-status=live}}</ref>

The decision on the relocation was made on 20 November 2017, during the EU [[General Affairs Council]] meeting,<ref name="auto"/> after three voting rounds and finally drawing of lots. After the first round of voting, [[Milan]] (25 votes), [[Amsterdam]] (20 votes) and [[Copenhagen]] (20 votes) were the only contenders left. After the second voting round, two cities were left: Milan (twelve votes) and Amsterdam (nine votes). These two cities tied in the subsequent vote (thirteen votes each), after which a drawing of lots identified Amsterdam as the host city of EMA.<ref>{{cite news|last=Bocci|first=Michele|date=20 November 2017|title=Ema, Milano passa al secondo turno di votazioni con Amsterdam e Copenhagen|trans-title=Ema, Milan passes second in terms of votes with Amsterdam and Copenhangen|language=it|work={{Lang|it|[[la Repubblica]]}}|url=http://www.repubblica.it/salute/medicina/2017/11/20/news/ema_oggi_per_milano_il_momento_della_verita_dublino_si_ritira_dalla_corsa-181604271/|url-status=live|access-date=20 October 2017|archive-url=https://web.archive.org/web/20201109025731/https://www.repubblica.it/salute/medicina/2017/11/20/news/ema_oggi_per_milano_il_momento_della_verita_dublino_si_ritira_dalla_corsa-181604271/|archive-date=9 November 2020}}</ref>

EMA staff left its London premises in March 2019 to relocate to a temporary building in Amsterdam, and by January 2020 the relocation to the permanent building in Amsterdam's [[Zuidas|Zuidas district]] was finalised.<ref name="Relocation"/> The EMA sought, unsuccessfully, to argue that their lease on the London premises could be terminated on the legal ground of "[[frustration in English law|frustration]]", because of the legal obligation of the EU to locate the agency within EU territory. The [[High Court of Justice|High Court]] ruled that the doctrine of frustration did not apply in the circumstances and the EMA was left in possession of a lease with much of its initial 25-year term still to run.<ref>McNair Chambers LLC, [https://www.mcnairinternational.com/client/publications/2019/ENGLISH%20HIGH%20COURT%20RULES%20BREXIT%20DOES%20NOT%20FRUSTRATE%20PROPERTY%20LEASE.pdf English High Court Gives Decision on Impact of Brexit on Frustration of Commercial Arrangements], accessed on 13 August 2025</ref>

=== 2020: COVID-19 ===
{{Main|European Union response to the COVID-19 pandemic}}
The EMA played a significant role in the response to the [[COVID-19 pandemic in the European Union]], seeking to expedite the development and approval of [[COVID-19 vaccine]]s and [[COVID-19 treatment|treatments]].<ref>{{Cite web |date=2020-01-29 |title=Coronavirus disease (COVID-19) |url=https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19 |url-status=live |archive-url=https://archive.today/20210922051938/https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19 |archive-date=2021-09-22 |access-date=2023-09-16 |website=European Medicines Agency |language=en}}</ref>

It participated in the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) [[public–private partnership]] hosted by the [[Foundation for the National Institutes of Health]], collaborating with international government agencies and corporations to coordinate a research strategy for prioritizing and speeding up development of COVID-19 vaccines and pharmaceutical products.<ref>{{Cite web |title=ACTIV |url=https://www.nih.gov/research-training/medical-research-initiatives/activ |url-status=dead |archive-url=https://archive.today/20220111042823/https://www.nih.gov/research-training/medical-research-initiatives/activ |archive-date=2022-01-11 |access-date=2023-09-16 |website=[[National Institutes of Health]] (NIH) |language=EN}}</ref>

While in the process of evaluating the [[Pfizer–BioNTech COVID-19 vaccine]] in December 2020, the EMA suffered a [[cyberattack]], resulting in the leak of classified regulatory documents to journalists, academics and the public via the [[dark web]].<ref>{{Cite news |last=Stubbs |first=Jack |date=2020-12-09 |title=Hackers steal Pfizer/BioNTech COVID-19 vaccine data in Europe, companies say |language=en |work=[[Reuters]] |url=https://www.reuters.com/article/us-ema-cyber-idUKKBN28J2Q7 |url-status=live |access-date=2023-09-16 |archive-url=https://web.archive.org/web/20230916173447/https://www.reuters.com/article/us-ema-cyber-idUKKBN28J2Q7 |archive-date=2023-09-16}}</ref><ref>{{Cite web |date=2021-01-15 |title=Cyberattack on EMA – update 5 |url=https://www.ema.europa.eu/en/news/cyberattack-ema-update-5 |url-status=live |archive-url=https://web.archive.org/web/20230916173203/https://www.ema.europa.eu/en/news/cyberattack-ema-update-5 |archive-date=2023-09-16 |access-date=2023-09-16 |website=European Medicines Agency |language=en}}</ref><ref>{{Cite web |date=2020-12-09 |title=Statement on EMA Cyberattack |url=https://www.pfizer.com/news/announcements/statement-ema-cyberattack |url-status=live |archive-url=https://web.archive.org/web/20230916173702/https://www.pfizer.com/news/announcements/statement-ema-cyberattack |archive-date=2023-09-16 |access-date=2023-09-16 |website=[[Pfizer]]}}</ref> The documents revealed internal concerns about low production quality in the [[mRNA vaccine]] candidate, and regulators' efforts to have [[Pfizer]] and [[BioNTech]] rectify these deficiencies.<ref>{{Cite journal |last=Tinari |first=Serena |date=2021-03-10 |title=The EMA covid-19 data leak, and what it tells us about mRNA instability |url=https://www.bmj.com/content/372/bmj.n627 |journal=BMJ |language=en |volume=372 |pages=n627 |doi=10.1136/bmj.n627 |issn=1756-1833 |pmid=33692030 |doi-access=free |access-date=16 September 2023 |archive-date=16 September 2023 |archive-url=https://web.archive.org/web/20230916174251/https://www.bmj.com/content/372/bmj.n627 |url-status=live }}</ref><ref>{{Cite journal |last=Abbasi |first=Jennifer |date=2021-04-13 |title=Data Leak Exposes Early COVID-19 Vaccine Manufacturing Hiccups |journal=[[JAMA]] |volume=325 |issue=14 |pages=1385 |doi=10.1001/jama.2021.5002 |issn=0098-7484|doi-access=free |pmid=33847730 }}</ref><ref>{{Cite web |last=Lovett |first=Samuel |date=2021-03-11 |title=European regulator raised concern over quality of early Pfizer vaccine batches, leaked emails show |url=https://www.independent.co.uk/news/science/covid-pfizer-vaccine-doses-uk-latest-b1815398.html |url-status=live |archive-url=https://web.archive.org/web/20230916174105/https://www.independent.co.uk/news/science/covid-pfizer-vaccine-doses-uk-latest-b1815398.html |archive-date=2023-09-16 |access-date=2023-09-16 |website=[[The Independent]] |language=en}}</ref> The EMA ultimately authorized the vaccine on 21 December 2020, satisfied that the product quality was "sufficiently consistent and acceptable."<ref>{{Cite web |last=Committee for Medicinal Products for Human Use (CHMP) |date=2021-02-19 |title=European public assessment report (EPAR) – Comirnaty, INN-COVID-19 mRNA Vaccine (nucleoside-modified) |url=https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf |url-status=live |archive-url=https://web.archive.org/web/20230912122645/https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf |archive-date=2023-09-12 |access-date=2023-09-16 |website=European Medicines Agency}}</ref><ref>{{Cite web |last=Kansteiner |first=Fraser |date=2021-03-15 |title=Pfizer's COVID-19 vaccine faced EMA manufacturing concerns ahead of emergency nod: report |url=https://www.fiercepharma.com/manufacturing/pfizer-s-covid-19-vaccine-subject-to-ema-manufacturing-concerns-ahead-december |url-status=live |archive-url=https://web.archive.org/web/20230710140521/https://www.fiercepharma.com/manufacturing/pfizer-s-covid-19-vaccine-subject-to-ema-manufacturing-concerns-ahead-december |archive-date=2023-07-10 |access-date=2023-09-16 |website=Fierce Pharma}}</ref>

== Comparison with other medical regulatory agencies ==
{{main |Regulation of therapeutic goods}}As of 2016, the EMA was roughly parallel to the drug part of the U.S. [[Food and Drug Administration]] (FDA),<ref name="Gu 2016">{{cite book|last1=Gu|first1=A|last2=Patel|first2=D|last3=Nayak|first3=R|editor1-last=Fulda|editor1-first=TR|editor2-last=Lyles|editor2-first=A|editor3-last=Wertheimer|title=Pharmaceutical Public Policy|date=2016|publisher=CRC Press|isbn=9781498748513|pages=151–160|chapter=Chapter 10: Drug shortages}}</ref> but without [[centralisation]].<ref name="Boslaugh 2015">{{cite book|last1=Boslaugh|first1=SE|title=The SAGE Encyclopedia of Pharmacology and Society|date=2015|publisher=SAGE Publications|isbn=9781506346182|chapter=European Medicines Agency}}</ref> The timetable for product approval via the EMA's centralised procedure of 210 days compares well with the average of 500 days taken by the FDA in 2008 to evaluate a product.<ref>{{cite web|url=https://www.fda.gov/downloads/Drugs/NewsEvents/UCM167310.pdf|title=Generic Drugs: Overview of ANDA Review Process|last=Sherwood|first=Ted|date=16 April 2008|publisher=[[Food and Drug Administration]] |access-date=30 January 2010 |url-status=dead|archive-url=https://web.archive.org/web/20170119061807/https://www.fda.gov/downloads/Drugs/NewsEvents/UCM167310.pdf|archive-date=19 January 2017}}</ref>

== See also ==
{{Div col}}
* [[Ethics Committee (European Union)|Ethics Committee]]
* [[EudraCT]]
* [[EudraGMP]]
* [[EudraLex]]
* [[EUDRANET]]
* [[EudraPharm]]
* [[EudraVigilance]]
* [[European and Developing Countries Clinical Trials Partnership]]
* [[European Centre for Disease Prevention and Control]] (ECDC)
* [[European Clinical Research Infrastructures Network]]
* [[European Federation of Pharmaceutical Industries and Associations]]
* [[European Forum for Good Clinical Practice]] (EFGCP)
* [[International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use|ICH]]
* [[Inverse benefit law]]
* [[Medicines and Healthcare products Regulatory Agency]] (MHRA, UK)
* [[Qualified Person|Qualified person]]
* [[Regulation of therapeutic goods]]
* [[Supplementary protection certificate]] (SPC)
* [[DARWIN EU]]{{Div col end}}

==References==
{{Reflist}}

== Further reading ==
* {{cite book |author=McCormick, John |title=The European Union: Politics and Policies |publisher=[[Westview Press]] |location=Boulder, Colo |year=2004 |isbn=0-8133-4202-3 |url-access=registration |url=https://archive.org/details/europeanunionpol0000mcco_d3k0 }}

==External links==
* {{official website|http://www.ema.europa.eu/}}
* [https://www.ema.europa.eu/en/documents/annual-report/2018-annual-report-european-medicines-agency_en.pdf EMA Annual Report 2018]
* [http://www.hma.eu/ Heads of Medicines Agencies]
* [http://ec.europa.eu/health/documents/eudralex/index_en.htm The Rules Governing Medicinal Products in the European Union] (EudraLex)
* [http://ec.europa.eu/health-eu/index_en.htm Health-EU Portal] official public health portal of the European Union

{{Agencies of the European Union|state=uncollapsed}}
{{Authority control}}

[[Category:1995 in the European Union]]
[[Category:Agencies of the European Union]]
[[Category:European medical and health organizations]]
[[Category:European Union health policy]]
[[Category:Government agencies established in 1995]]
[[Category:International organisations based in the Netherlands]]
[[Category:Medical and health organisations based in the Netherlands]]
[[Category:National agencies for drug regulation]]
[[Category:Organisations based in Amsterdam]]
[[Category:Regulators of biotechnology products]]
[[Category:Regulation in the European Union]]