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The Agency should not be confused with the European Directorate for the Quality of Medicinal Products. Overview of the European Medicines AgencyFormed 1 January 1995; 25 years ago (1995-01-01)JurisdictionEuropean UnionHeadquartersAmsterdam, Netherlands[1]MottoScience. Medicines. Health.Employees897 [2]Annual budget 358.1 million (2020) [3]Employees of Guido Rasi Organization, Executive DirectorChrista Wirthumer-Hoche, 726/2004Websiteema.europa.euMapAmsterdamEuropean Medicines Agency (European Union) European Union This article is part of a series on the policy and government of the Member States of the European Union (27 ) Austria Belgium Cyprus Estonia Finland France Germany Greece Ireland Italy Latvia Lithuania Luxembourg Malta Netherlands Portugal Slovakia Slovenia Spain Candidate countries for EU membership Albania Bosnia and Herzegovina North Macedonia Turkey Special territories member France-Germany relations EU 3 Withdrawal from Treaties of the European Union Treaty of Paris (1951) (1957) Euratom Treaty (1957) Merger Treaty (1965) (1986) Treaty of Maastricht (1992) (1997) (2001) (2007) Article 7 Article 50 Accession agreements 1972 , 1979, 1985, 1994, 2003, 2005, 2011 Treaties of Succession 1984, 2020 Other Treaties Schengen Agreement (1985) EEA Agreement (1992) Abandoned treaties and agreements European Constitution (2004) UK renegotiation of EU membership (2015–2016) ExecutiveEuropean Council President: Michel (ALDE) Parties List of meetings Von der Leyen Commission President: Von der Leyen (EPP) Vice Presidents College of Commissioners Civil Service Secretary-General: Juhansone Legislature Legislative procedure Council of the EU Presidency Germany (July - December 2020) Configurations General Foreign Economic Justice and Home Voting Secretariat Secretary-General: Uwe Corsepius Directorates-general COREPER (Members) President: Sassoli (S&D) Largest groups EPP (Manfred Weber) S&D (Iratxe García) Member of the European Parliament 9th session (2019–2024) Bureau Vice Presidents Quaestor Conference National parliaments JudiciaryCourt of Justice of the EU Court of Justice Members Rulings General Court EuroEurozone Members Austria Belgium Cyprus Estonia Finland France Germany Greece Ireland Italy Latvia Lithuania Luxembourg Malta Netherlands Portugal Slovakia Slovenia Spain Eurogroup President Mário Centeno President Lagarde ESCB EMU Banking Union CMU Coins Economic and Monetary Union Schengen AreaChengen Member States Austria Belgium Czech Republic Denmark Estonia Finland Germany Greece Hungary Hungary (non-EU State) Italy Latvia Liechtenstein (non-EU State) Lithuania Luxembourg Malta Netherlands Norway (non-EU State) Poland Portugal Slovakia Slovenia Spain Switzerland (non-EU State) Convention Püm Convention Schengen Information System Visas Visa Policy of the European Economic AreaEA Members Austria Belgium Bulgaria Cyprus Czech Republic Denmark Estonia Finland France Germany Greece Hungary Iceland (non-EU State) Ireland Italy Latvia Liechtenstein (non-EU State) Lithuania Luxembourg Netherlands Norway (non-EU State) Slovakia Spain Sweden United Kingdom (non-EU State) Gibraltar EEA Eea Joint Committee National Identities Microstate and the Court of Auditors of the European Union Budget OLAF Other bodies European Atomic Energy Community Organisations Investment Funds Erdf Ombudsman Former European Organisations (1958-1993) European Coal and Steel Community Elections of the European Economic Community 1979, 1984, 1989, 19941999, 2004, 2009, 2014 2019 (last elections) European political parties Elections in EU Member States Austria Belgium Bulgaria Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Greece Hungary Ireland Italy Latvia Lithuania Luxembourg Malta Netherlands Poland Portugal Romania Slovakia Slovenia Spain Sweden Referendums on the law of the Supremacy Authority Regulation Directive Decision Fundamental Rights Policies and issues Budget Community Preference Customs Union Free trade agreements Zone of FS&J Policies Agricultural Energy Fishing Regional Citizenship Passport of the European Union Identity Pro-Europeanism Integration Transnationalism Federalism United States of Europe Enhanced co-op Other currencies use Danish forint Polish złoty PSI II Enlargement of the euro area Czech Republic and the euro Non-Schengen States Bulgaria Croatia Cyprus Cyprus Ireland Romania Common travel area (Ireland) Multi-speed Europe Foreign Policy High Representative Josep Borrell Ext. Action Service Foreign Policy Defence Policy Relations External relations of EU Member States Austria Belgium Belgium Bulgaria Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Greece Hungary Ireland Italy Lutian Lithuania Luxembourg Malta Netherlands Poland Romania Slovakia Slovenia Spain Sweden European Union-Turkey relations Norway-European Union relations European Union Relations United States-European Union Relations European Union Relations European Union-United Kingdom (History) Post-Brexit Relations United Kingdom with the European Union) Brexit and the European Union and the Association Agreement of the European Union of the United Nations G7 G20 European Union portal Other countries vte The European Medicines Agency (EMA) is a European Union (EU) body responsible for the evaluation and supervision of medicines. Prior to 2004, it was known as the European Medicines Evaluation Agency or the European Medicines Evaluation Agency (EIA). [4] [5] The EMA was established in 1995, with funding from the European Union and the pharmaceutical industry, as well as indirect subsidies from the Member States, its stated intention to harmonise (but not replace) the work of existing national medical regulators. The hope was that this plan would not only reduce the annual pharmaceutical companies cost 350 million euros resulting from having to win separate approvals from each Member State, but also that it would eliminate protectionist tendencies of sovereign states that do not wish to approve new medicines that could compete with those already produced by domestic pharmaceutical companies. Coreper was established after more than seven years of negotiations between EU governments and replaced the Committee on Proprietary Medicinal Products and the Committee for Veterinary Medicinal Products, although both were reborn as key scientific advisory committees. The agency was in London before the UK's vote to leave the European Union, relocated to Amsterdam in March 2019. [6] [7] Functions This section does not mention sources. Help improve this section by adding references to trusted sources. Material without resources can be challenged and removed. (September 2019) (Learn how and when to remove this standard message) In particular, it coordinates the evaluation and monitoring of centrally approved products and national referrals, develops technical guidance and provides scientific advice to donors. Its scope of work is medicinal products for human and veterinary use, including biological and advanced therapies, as well as herbal medicinal products. The Agency consists of the Secretariat (approximately 600 staff), a Board of Directors, seven scientific committees (human medicines, veterinary and herbal medicinal products, orphan medicinal products, paediatrics, advanced treatments and pharmacovigilance risk assessment) and a number of working groups. The Secretariat is organized into five units: Directorate of Drug Development and Evaluation, Patient Health Protection and Evaluation, Veterinary Medicines and Product Data Management, Technology and Information and Communication Management. The Board of Directors administrative supervision in the Agency: including the approval of budgets and plans and the selection of the Executive Director. The Management Board shall comprise one representative from each of the 28 Member States, two representatives of the European Commission, two representatives of the European Parliament, two representatives of patient organisations, one representative of doctors' organisations and one representative of veterinary organisations. The Agency decentralises its scientific evaluation of medicines through a network of around 4500 experts across the EU. The EMA is based on the resources of more than 40 national competent authorities (ESDs) of the EU Member States. Central marketing authorisations This section does not mention sources. Help improve this section by adding references to trusted sources. Material without resources can be challenged and removed. (September 2019) (Learn how and when to remove this template message) The centralised procedure is mandatory 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, autoimmune and other immunological dysfunctions, as well as viral diseases, as well as veterinary medicinal products used to develop or enhance performance. It is also mandatory for advanced therapy medicines, such as gene therapy, somatic cell therapy or tissue engineering drugs, as well as for orphan medicines (medicines for rare diseases). The centralised procedure shall also be open to products which bring about significant therapeutic, scientific or technical innovation or are in any other respect in the interests of patient or animal health. Therefore, the majority of truly new medicines are approved through the EMA. For products that are eligible or require central approval, the company applies for a marketing authorisation to the EMA. [reference required] Committee of Committees for Medicinal Products for Human Use A single evaluation shall be carried out through the Committee for Medicinal Products for Human Use (CHMP). [8] If the Committee concludes that the quality, safety and efficacy of the medicinal product are sufficiently proven, it shall issue a positive opinion. This is sent to the European Commission to be converted into an EU-wide marketing authorisation. A specific type of authorisation is the Paediatric Use Marketing Authorisation (PUMA), which may be granted medical products intended exclusively for paediatric use. [9] The CHMP is required by the Regulation to take decisions within 210 days, days, the clock shall be interrupted if it is necessary to ask the applicant for clarification or further supporting information. [reference required] Committee for Medicinal Products for Veterinary Use The Committee for Medicinal Products for Veterinary Use (CVMP) operates in proportion to the CHMP as described above. [10] Committee for Orphan Medicinal Products This section does not mention sources. Help improve this section by adding references to trusted sources. Material without resources can be challenged and removed. (September 2019) (Learn how and when to remove this standard message) Companies intending to develop medicines to diagnose, prevent or treat life-threatening or very serious diseases that do not affect more than five in 10,000 people in the European Union can apply for an 'orphan drug designation'. COMP evaluates the application and makes a recommendation on the definition, which is then granted by the European Commission. [reference required] Committee for Herbal Medicinal Products This section does not mention sources. Help improve this section by adding references to trusted sources. Material without resources can be challenged and removed. (September 2019) (Learn how and when to remove this standard message) Paediatric Committee This section does not mention sources. Help improve this section by adding references to trusted sources. Material without resources can be challenged and removed. (September 2019) (Learn how and when to remove this standard message) According to this legislation, all applications for authorisation of new medicinal products, or amendments to existing authorisations, must either include data from paediatric studies previously agreed with the PDCO, or be exempted from the PDCO or postponed. Committee for Advanced Therapies The Committee for Advanced Therapies (CAT) was set up in accordance with Regulation (EC) No 1782/2003. It assesses the quality, safety and effectiveness of ATMs and monitors scientific developments in this field. [11] Pharmacovigilance Risk Assessment Committee A seventh committee, the Pharmacovigilance Risk Assessment Committee (PRAC) was launched in 2012 with the implementation of the new EU Pharmacovigilance Committee (Directive 2010/84/EU). [12] Other activities This section does not mention sources. Help improve this section by adding references to trusted sources. Material without resources can be challenged and removed. (September 2019) (Learn how and when to remove this standard message) Referrals: The Agency shall coordinate arbitration procedures concerning medicinal products authorised or examined by Member States in non-centralised authorisation procedures. Scientific advice: Companies wishing to obtain scientific advice from the CHMP or CVMP on the appropriate tests and studies to be carried out for the development of a medicinal product may request it before or during the development programme. Telematics projects: The Agency is responsible for implementing a central set of pan-European systems and databases, such as Eudra Vigilance, EudraCT and EudraPharm. Relocation Following the UK's 2016 decision to leave the European Union (Brexit), the EMA chose to look for another business base. Under EU law, the European Commission had to decide on the fate of the EMA site. EU ministers met to vote for their preferred successor. [13] EU Health Commissioner Vytenis Andriukaitis said the preferred option would be a location where an easy creation and guarantee of smooth operation would be available. The Member States that had expressed their offer for the new EMA site were Austria,[14] Belgium, Bulgaria,[15] Croatia,[14] Cyprus, [14] Czech Republic,[14] Denmark,[14] Finland,[16] France,[14] Germany,[14] Greece,[14] Greece,[14] Finland,[14] Finland,[14] Finland,[ [14] Germany,[14] Greece,[14] Greece,[14] Hungary,[14] Ireland,[14] Italy,[14] Malta,[14] Netherlands,[14] [17] Poland,[15] Portugal,[18] Romania,[19][20] Slovakia,[14] Slovenia,[14] Spain,[14] and Sweden. [21] [22] [23] It was also speculated that the seat of the European Parliament based in Strasbourg could be moved to Brussels in exchange for the city hosting the EMA. [24] Others speculate on the advantages of Amsterdam, long before the final decision is taken. [25] [26] The relocation decision was taken on 20 November 2017, at the meeting of the EU [26], after three rounds of voting and a final draw. After the first round of Milan (25 votes), Amsterdam (20 votes) and Copenhagen (20 votes) were the only candidates left. [27] After the second round of voting, two cities remained: Milan (twelve votes) and Amsterdam (nine votes). These two cities are tied on the next ballot (thirteen votes each), after which a draw identified Amsterdam as host of the EMA. It is unclear what future arrangements the UK intends to make for its own post-EU medical assessment. Paul Workman, the president of the London-based Cancer Research Institute, has suggested that pharmaceutical companies will naturally seek regulatory approval for new drugs in the biggest markets first, leaving the UK facing delays in approval if they create independent regulations. [28] Criticism of the EMA procedure The European Medicines Agency's review process on medical issues has been criticised for its lack of transparency and conflict of interest issues. [29] In a disprove of an EMS review that included her work, Louise Brinth, a Danish doctor, noted that experts examining the data remain anonymous and appear to be bound to secrecy. The minutes are not published and there are no divergent views indicating that all experts are of the same opinion. In her view, the process is unscientific and undemocratic. [30] Comparison with other regulatory agencies Ema is approximately parallel to the Medicines Department of the US Food and Drug Administration (FDA),[31] but without concentration. [32] The schedule for product approval through the 210-day CENTRAL EMA process compares well with the FDA's 500-day average for evaluating a product. [33] See also Ethics Committee EudraCT EudraGMP EudraPlex EUDRANET EudraPharm EudraVigilance European and Developing Countries Clinical Trials Partnership European Clinical Research Infrastructures Network European Federation of Pharmaceutical Industries and Associations European Forum of Good Clinical Practice (EFGCP) ICH Reverse benefits fair Medicines and healthcare products Regulatory Agency (MHRA, UK) Qualified person Regulation on therapeutic goods Supplementary Protection Certificate (SPC) European Banking Authority References ^ Relocation to Amsterdam. European Medicines Agency. 17 September 2018. Retrieved September 16, 2019. ^ 'European Medicines Agency (EMA) | European Union'. europa.eu 26 February 2020. ^ Financing | European Medicines Agency (EMA)'. European Medicines Agency. 26 February 2020. ^ It was established by Council Regulation (EC) No 1257/1999 of 17 The European Medicines Agency does not call itself EMA either - it does not have an official acronym, but may review whether EMA is commonly accepted (see notice on new visual identity Archived June 1, 2010 in Wayback Machine and logo Archived December 25, 2009 in Wayback Machine). ^ EME becomes EMA. PMLive. 14 December 2009. ^ Hrabovszki, Georgina (March 11, 2019). The EMA now from Amsterdam. European Medicines Agency. Retrieved March 12, 2019. ^ The United Kingdom's withdrawal from the European Union (Brexit). («Brexit»)». Medicines Agency. 17 September 2018. Retrieved September 16, 2019. ^ 'Commission on the Human Use of Medicinal Products (CHMP)'. European Medicines Agency (EMA). Retrieved July 26, 2020. ^ Questions and Answers on the Paediatric Marketing Authorisation (PUMA) (PDF). European Medicines Agency (EMA). 13 September 2011. Archived from the original (PDF) on April 15, 2016. ^ 'Committee on the Veterinary Use of Medicinal Products (CVMP)'. European Medicines Agency (EMA). Retrieved July 26, 2020. ^ European Medicines Agency (3 December 2019). Committee for Advanced Therapies (CAT). European Medicines Agency. Retrieved December 3, 2019. ^ European Medicines Agency (3 December 2019). Committee for the Risk Assessment of Pharmacovigilance (PRAC). European Medicines Agency. Retrieved December 3, 2019. ^ - Offers to host the European Medicines Agency (EMA). Retrieved September 14, 2017. ^ α β γ δ ε φ γ χ ι λ μ ν ο «Reuters - Είκοσι μια χώρες ανταγωνίζονται για να φιλοξενήσουν την αντιπροσωπεία φαρμάκων της ΕΕ μετά από το Brexit». Retrieved August 10, 2017. ^ a b European Council - Offers to host the European Medicines Agency (EMA). Retrieved August 10, 2017. ^ Finland is an excellent place for the European Medicines Agency. Sociaali-ja tervesministerio. Retrieved April 18, 2017. ^ Home - the Dutch offer for EMA. The Dutch offer for EMA. Archived from the original on July 14, 2017. Retrieved July 13, 2017. ^ Countries align to host the European Medicines Agency after the UK leaves. 15 February 2017. Retrieved May 8, 2017. ^ Romania looks to poaching the EU drug agency from the UK. 23 March 2017. Retrieved May 8, 2017. ^ A Brexit Pill for Romania. 13 April 2017. Retrieved May 8, 2017. ^ Patrick Wintour. Countries are lining up to host the European Medicines Agency after leaving the UK. The Guardian. Retrieved April 1, 2017. ^ Julia Bradshaw (December 8, 2016). Sweden is launching a campaign to host the EU's drug service instead of the UK after Brexit. The Telegraph. Retrieved April 1, 2017. ^ Andreja Zapcic (March 29, 2017). Kujundžić: Hrvatska je spremna preuzeti Europsku agenciju za lijekove (in Croatian). Tportal.hr. Retrieved April 1, 2017. ^ Strasbourg could exchange the seat of Parliament for the drug agency. 10 May 2017. ^ PharmaTimes, September 27, 2017. EMA staff are in favour of moving to Amsterdam. Retrieved October 19, 2017. ^ a b Nature News, 2017. European drug regulation risks being delayed as the agency prepares to leave London. Retrieved October 13, 2017. ^ Ema, Milano passa al secondo turno di votazioni con Amsterdam e Copenhagen (in Italian). Retrieved October 20, 2017. ^ Brexit: People will die because of plans to create UK-only drug regulator, cancer expert warns. The Independent. 10 February 2017. Retrieved February 11, 2017. ^ Our News. nordic.cochrane.org. ^ Louise Brinth: HPV Vaccine Evaluation Report released by EMA on November 26, 2015., online (PDF, 1.3 MB) ^ Gu, A; Patel, D? Nayak, R (2016). (2016). 10: Drug shortages'. In Fulda, TR; Lyles, A? Wertheimer (eds.). Pharmaceutical Public Policy. CRC Press. Sna. ISBN 9781498748513. ^ Boslaugh, SE (2015). 'European Medicines Agency'. The SAGE Encyclopedia of Pharmacology and Society. SAGE Publications. ISBN 9781506346182. ^ Sherwood, Ted (April 16, 2008). Generic medicines: Overview of the ANDA review process (PDF). Food and Drug Administration. Archived from the original (PDF) on January 19, 2017. Retrieved January 30, 2010. Further reading McCormick, John (2004). European Union: Politics and Policies. Boulder, Colo.: Westview Press. ISBN 0-8133-4202-3. External links Official website EMA Annual report 2018 Heads of Medicines Organisations The rules governing medicinal products in the European Union (EudraLex) Health Portal-EU Official Public Health Portal of the European Union Recovered from

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