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Ema Regulatory Guidelines Pdf Ema regulatory guidelines pdf Continue The European Union 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 euros (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 Bulgaria Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Greece Hungary Ireland Italy Latvia Lithuania Luxembourg Malta Netherlands Poland Portugal Slovakia Slovenia Spain Sweden Candidate countries for EU membership Albania Bosnia and Herzegovina Montenegro North Macedonia Serbia Turkey Special territories member France-Germany relations EU 3 Withdrawal from Treaties of the European Union Treaty of Paris (1951) Treaty of Rome (1957) Euratom Treaty (1957) Merger Treaty (1965) Single European Act (1986) Treaty of Maastricht (1992) Treaty of Amsterdam (1997) Treaty of Nice (2001) Treaty of Lisbon (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 European Commission 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 Eurogroup Justice and Home Voting Secretariat Secretary-General: Uwe Corsepius Directorates-general COREPER European Parliament(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 European Central Bank President Lagarde ESCB EMU Banking Union CMU Euro Coins Euro Coins Economic and Monetary Union Schengen AreaChengen Region 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 Schengen Area 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) Romania 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 acquis communautaire Supremacy Authority Regulation Directive Decision Fundamental Rights Policies and issues Budget Community Preference Customs Union Free trade agreements European Single Market Zone of FS&J Policies Agricultural Energy Fishing Regional Citizenship Passport of the European Union Identity Pro-Europeanism Euroscepticism Integration Transnationalism Federalism United States of Europe Enhanced co-op Other currencies use Bulgarian lev Croatian kuna Czech koruna Danish forint Polish złoty Romanian leu Swedish krona PSI II Enlargement of the euro area Bulgaria and the euro Croatia and the euro Czech Republic and the euro Denmark and the euro Hungary and the euro Poland and the euro Sweden and the euro Romania 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
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