European Medicines Agency

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Not to be confused with European Directorate for the Quality of Medicines.

European Medicines Agency

Agency overview

Formed 1 January 1995; 25 years ago

Jurisdiction European Union

Headquarters Amsterdam, Netherlands[1]

Motto Science. Medicines. Health.

Employees 897 [2]

Annual budget €358.1 million (2020) [3]

Guido Rasi, Executive Director

Agency executives
Christa Wirthumer-Hoche,

Chairperson

Key document  Regulation (EC) No. 726/2004

Website ema.europa.eu

Map
Amsterdam

European Medicines Agency (European Union)

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The European Medicines Agency (EMA) is an agency of the European Union (EU) in

charge of the evaluation and supervision of medicinal products. Prior to 2004, it was
known as the European Agency for the Evaluation of Medicinal
Products or European Medicines Evaluation Agency (EMEA).[4][5]
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 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 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 United Kingdom's vote for withdrawal from the European Union, relocating
to Amsterdam in March 2019.[6][7]

Contents

 1Operations
 2Centralised marketing authorisations
 3Committees
o 3.1Committee for Medicinal Products for Human Use
o 3.2Committee for Medicinal Products for Veterinary Use
o 3.3Committee on Orphan Medicinal Products
o 3.4Committee on Herbal Medicinal Products
o 3.5Paediatric Committee
o 3.6Committee for Advanced Therapies
o 3.7Pharmacovigilance Risk Assessment Committee
 4Other activities
 5Relocation
 6Criticism of the EMA process
 7Comparison with other regulatory agencies
 8See also
 9References
 10Further reading
 11External links

Operations[edit]
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The EMA operates as a decentralised scientific agency (as opposed to a regulatory

authority) of the European Union 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. 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 medicinal products. The agency is composed of the Secretariat
(ca. 600 staff), a management board, seven scientific committees (human, veterinary
and herbal medicinal products, orphan drugs, 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 28 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 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.

Centralised marketing authorisations[edit]

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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 EU and European Economic Area (EEA)-
European Free Trade Association (EFTA) states (Iceland, Liechtenstein and Norway).
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. 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. [citation needed]

Committees[edit]
Committee for Medicinal Products for Human Use[edit]
A single evaluation is carried out through the Committee for Medicinal Products for
Human Use (CHMP). 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.[8]
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.[citation needed]
Committee for Medicinal Products for Veterinary Use[edit]
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The Committee for Medicinal Products for Veterinary Use (CVMP) operates in analogy
to the CHMP as described above.[citation needed]
Committee on Orphan Medicinal Products[edit]
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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.[citation needed]
Committee on Herbal Medicinal Products[edit]
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The Committee on Herbal Medicinal Products (HMPC) assists the harmonisation of
procedures and provisions concerning herbal medicinal products laid down in EU
Member States, and further integrating herbal medicinal products in the European
regulatory framework since 2004.
Paediatric Committee[edit]
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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 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.
Committee for Advanced Therapies[edit]
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 engineered products. It assesses the
quality, safety and efficacy of ATMPs, and follows scientific developments in the field. [9]
Pharmacovigilance Risk Assessment Committee[edit]
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).[10]

Other activities[edit]
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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.
Relocation[edit]
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.[11] 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.
Member states who had expressed their bid for the new EMA location were Austria,
[12]
 Belgium, Bulgaria,[13] Croatia,[12] Cyprus,[12] Czech Republic,[12] Denmark,[12] Finland,
[14]
 France,[12] Germany,[12] Greece,[12] Hungary,[12] Ireland,[12] Italy,[12] Malta,[12] the Netherlands,
[15]
 Poland,[13] Portugal,[16] Romania,[17][18] Slovakia,[12] Slovenia,[12] Spain,[12] and Sweden.[19][20][21]
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.
[22]
 Others speculated on the merits of Amsterdam, well before the final decision was
made.[23][24]
The decision on the relocation was made on 20 November 2017, during the EU General
Affairs Council meeting,[24] 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.[25] 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.
It is unclear what future arrangements the United Kingdom proposes to make for its own
medicinal evaluation after leaving the EU. Paul Workman, the president of the London-
based Institute of Cancer Research, has suggested that pharmaceutical companies
would naturally seek regulatory approval for new drugs in the biggest markets first,
leaving the UK facing delays in approval if they set up independent arrangements. [26]

Criticism of the EMA process[edit]

The review process of the European Medicines Agency regarding medical issues has
been criticized for its lack of transparency and issues of conflict of interest. [27] 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.[28]

Comparison with other regulatory agencies[edit]

The EMA is roughly parallel to the drug part of the U.S. Food and Drug
Administration (FDA),[29] but without centralisation.[30] 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 to evaluate a product.[31]

See also[edit]
 Ethics Committee
 EudraCT
 EudraGMP
 EudraLex
 EUDRANET
 EudraPharm
 EudraVigilance
 European and Developing Countries Clinical Trials Partnership
 European Clinical Research Infrastructures Network
 European Federation of Pharmaceutical Industries and Associations
 European Forum for Good Clinical Practice  (EFGCP)
 ICH
 Inverse benefit law
 Medicines and Healthcare products Regulatory Agency  (MHRA, UK)
 Qualified person
 Regulation of therapeutic goods
 Supplementary protection certificate (SPC)
 European Banking Authority

References[edit]
1. ^ "Relocation to Amsterdam".  European Medicines Agency. 17 September 2018.
Retrieved  16 September 2019.
2. ^ "European Medicines Agency (EMA) | European Union". europa.eu. 26 February 2020.
3. ^ "Funding | European Medicines Agency (EMA)".  European Medicines Agency. 26 February
2020.
4. ^ 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 communication on new visual identity Archived 1 June 2010 at the Wayback
Machine and logo Archived 25 December 2009 at the Wayback Machine).
5. ^ "EMEA becomes EMA".  PMLive. 14 December 2009.
6. ^ Hrabovszki, Georgina (11 March 2019).  "EMA now operating from Amsterdam". European
Medicines Agency. Retrieved  12 March 2019.
7. ^ "United Kingdom's withdrawal from the European Union ('Brexit')".  European Medicines
Agency. 17 September 2018. Retrieved  16 September 2019.
8. ^ "Questions and answers on the paediatric use marketing authorisation (PUMA)"  (PDF).
European Medicines Agency. 13 September 2011. Archived from  the original  (PDF)  on 15 April 2016.
9. ^ European Medicines Agency (3 December 2019). "Committee for Advanced Therapies
(CAT)".  European Medicines Agency. Retrieved 3 December 2019.
10. ^ European Medicines Agency (3 December 2019). "Pharmacovigilance Risk Assessment
Committee (PRAC)". European Medicines Agency. Retrieved  3 December  2019.
11. ^ "European Council - Offers to host the European Medicines Agency (EMA)". Retrieved 14
September 2017.
12. ^ Jump up to:a b c d e f g h i j k l m n o "Reuters - Twenty-one countries vie to host EU drug agency after
Brexit". Retrieved 10 August  2017.
13. ^ Jump up to:a b "European Council - Offers to host the European Medicines Agency (EMA)".
Retrieved  10 August 2017.
14. ^ "Finland is an excellent place for European Medicines Agency".  Sosiaali- ja
terveysministeriö. Retrieved 18 April  2017.
15. ^ "Homepage - The Dutch Bid for EMA". The Dutch Bid for EMA. Archived from the
original  on 14 July 2017. Retrieved  13 July 2017.
16. ^ "Countries line up to host European Medicines Agency after it leaves UK". 15 February
2017. Retrieved 8 May  2017.
 17. ^ "Romania looks to poach EU medicines agency from UK". 23 March 2017. Retrieved 8
May  2017.
18. ^ "A Brexit pill for Romania". 13 April 2017. Retrieved  8 May 2017.
19. ^ Patrick Wintour.  "Countries line up to host European Medicines Agency after it leaves UK |
World news". The Guardian. Retrieved 1 April 2017.
20. ^ Julia Bradshaw (8 December 2016).  "Sweden launches campaign to host EU drugs agency
instead of UK after Brexit". Telegraph.co.uk. Retrieved  1 April  2017.
21. ^ Andreja Zapcic (29 March 2017).  "Kujundžić: Hrvatska je spremna preuzeti Europsku
agenciju za lijekove"  (in Croatian). Tportal.hr. Retrieved  1 April  2017.
22. ^ "Strasbourg could trade Parliament seat for medicines agency". 10 May 2017.
23. ^ "PharmaTimes, 27th September 2017. EMA staff favour move to Amsterdam". Retrieved  19
October 2017.
24. ^ Jump up to:a b "Nature News, October 2017. European drug regulation at risk of stalling as
agency prepares to leave London". Retrieved  13 October 2017.
25. ^ "Ema, Milano passa al secondo turno di votazioni con Amsterdam e Copenhagen"  (in
Italian). Retrieved  20 October 2017.
26. ^ "Brexit: People will die because of plans to set up UK-only drug regulator, cancer specialist
warns". Independent. 10 February 2017. Retrieved  11 February  2017.
27. ^ "Our news".  nordic.cochrane.org.
28. ^ Louise Brinth: Responsum to Assessment Report on HPV-vaccines released by EMA
November 26th 2015., online (PDF; 1,3 MB)
29. ^ Gu, A; Patel, D; Nayak, R (2016). "Chapter 10: Drug shortages". In Fulda, TR; Lyles, A;
Wertheimer (eds.). Pharmaceutical Public Policy. CRC Press. pp. 151–160. ISBN 9781498748513.
30. ^ Boslaugh, SE (2015). "European Medicines Agency". The SAGE Encyclopedia of
Pharmacology and Society. SAGE Publications. ISBN 9781506346182.
31. ^ Sherwood, Ted (16 April 2008).  "Generic Drugs: Overview of ANDA Review
Process"(PDF).  Food and Drug Administration. Archived from the original  (PDF) on 19 January 2017.
Retrieved  30 January 2010.

Further reading[edit]
 McCormick, John (2004). The European Union: Politics and Policies. Boulder,
Colo: Westview Press. ISBN 0-8133-4202-3.

External links[edit]
 Official website
 EMA Annual Report 2018
 Heads of Medicines Agencies
 The Rules Governing Medicinal Products in the European Union  (EudraLex)
 Health-EU Portal official public health portal of the European Union
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