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The European Medicines Agency (EMA) is an
agency of the European Union The agencies of the European Union (formally: ''Agencies, decentralised independent bodies, corporate bodies and joint undertakings of the European Union and the Euratom'') are bodies of the European Union and the Euratom established as juridica ...
(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).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 (se
communication on new visual identity
an

).
The EMA was set up in 1995, with funding from the
European Union The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been des ...
and the
pharmaceutical industry The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate symptoms. ...
, as well as indirect subsidy from member states, its stated intention to harmonise (but not replace) the work of existing national
medicine Medicine is the science and practice of caring for a patient, managing the diagnosis, prognosis, prevention, treatment, palliation of their injury or disease, and promoting their health. Medicine encompasses a variety of health care pract ...
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 Protectionism, sometimes referred to as trade protectionism, is the economic policy of restricting imports from other countries through methods such as tariffs on imported goods, import quotas, and a variety of other government regulations. ...
tendencies of
sovereign state A sovereign state or sovereign country, is a polity, political entity represented by one central government that has supreme legitimate authority over territory. International law defines sovereign states as having a permanent population, defin ...
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 London is the capital and largest city of England and the United Kingdom, with a population of just under 9 million. It stands on the River Thames in south-east England at the head of a estuary down to the North Sea, and has been a majo ...
prior to the United Kingdom's vote for withdrawal from the European Union, relocating to
Amsterdam Amsterdam ( , , , lit. ''The Dam on the River Amstel'') is the Capital of the Netherlands, capital and Municipalities of the Netherlands, most populous city of the Netherlands, with The Hague being the seat of government. It has a population ...
in March 2019.


Operations

The EMA operates as a decentralised scientific agency (as opposed to a regulatory authority) of the
European Union The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been des ...
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 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 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.


Committees


Medicinal products for human use

A single evaluation is carried out through the
Committee for Medicinal Products for Human Use The Committee for Medicinal Products for Human Use (CHMP), formerly known as Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regarding ...
(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 The European Commission (EC) is the executive of the European Union (EU). It operates as a cabinet government, with 27 members of the Commission (informally known as "Commissioners") headed by a President. It includes an administrative body o ...
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 Paediatric-use marketing authorisations (PUMA) are granted by the European Medicines Agency (EMA) for medical products that are intended exclusively for paediatric use, that is, for use in patients younger than 18 years. Like ordinary EMA marketing ...
(PUMA), which can be granted for medical products intended exclusively for paediatric use. 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.


Medicinal products for veterinary use

The
Committee for Medicinal Products for Veterinary Use The Committee for Medicinal Products for Veterinary Use (CVMP) is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regarding veterinary medicines. Text was copied from this source which is © ...
(CVMP) operates in analogy to the CHMP as described above.


Orphan medicinal products

The Committee on Orphan Medicinal Products (COMP) administers the granting of
orphan drug An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance. The conditions are referred to as orphan diseases. The assignment of ...
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 The European Commission (EC) is the executive of the European Union (EU). It operates as a cabinet government, with 27 members of the Commission (informally known as "Commissioners") headed by a President. It includes an administrative body o ...
.


Herbal medicinal products

The
Committee on Herbal Medicinal Products The Committee on Herbal Medicinal Products (HMPC), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on herbal medicines. Role HMPC aims at assisting in the harmonization of procedures and provisions con ...
(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.


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
marketing authorisation Marketing authorisation is the process of reviewing and assessing the evidence to support a medicinal product, such as a drug, in relation to its marketing, finalised by granting of a licence to be sold. This process is performed within a legal fr ...
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.


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 Gene therapy is a medical field which focuses on the genetic modification of cells to produce a therapeutic effect or the treatment of disease by repairing or reconstructing defective genetic material. The first attempt at modifying human DN ...
,
somatic cell A somatic cell (from Ancient Greek σῶμα ''sôma'', meaning "body"), or vegetal cell, is any biological cell forming the body of a multicellular organism other than a gamete, germ cell, gametocyte or undifferentiated stem cell. Such cells compo ...
therapy and tissue engineered products. It assesses the quality, safety and efficacy of ATMPs, and follows scientific developments in the field.


Pharmacovigilance risk assessment

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).


Other activities

The Agency carries out a number of activities, including: *
Pharmacovigilance Term Given By Tushar Sharma (UPES Batch 2025) Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharma ...
: 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 and in
Iceland Iceland ( is, Ísland; ) is a Nordic island country in the North Atlantic Ocean and in the Arctic Ocean. Iceland is the most sparsely populated country in Europe. Iceland's capital and largest city is Reykjavík, which (along with its s ...
,
Liechtenstein Liechtenstein (), officially the Principality of Liechtenstein (german: link=no, Fürstentum Liechtenstein), is a German-speaking microstate located in the Alps between Austria and Switzerland. Liechtenstein is a semi-constitutional monarchy ...
and
Norway Norway, officially the Kingdom of Norway, is a Nordic country in Northern Europe, the mainland territory of which comprises the western and northernmost portion of the Scandinavian Peninsula. The remote Arctic island of Jan Mayen and t ...
. 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 An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance. The conditions are referred to as orphan diseases. The assignment of ...
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 The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been des ...
and the
pharmaceutical industry The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate symptoms. ...
, as well as indirect subsidy from member states, its stated intention to harmonise (but not replace) the work of existing national
medicine Medicine is the science and practice of caring for a patient, managing the diagnosis, prognosis, prevention, treatment, palliation of their injury or disease, and promoting their health. Medicine encompasses a variety of health care pract ...
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 Protectionism, sometimes referred to as trade protectionism, is the economic policy of restricting imports from other countries through methods such as tariffs on imported goods, import quotas, and a variety of other government regulations. ...
tendencies of
Sovereign state A sovereign state or sovereign country, is a polity, political entity represented by one central government that has supreme legitimate authority over territory. International law defines sovereign states as having a permanent population, defin ...
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 London is the capital and largest city of England and the United Kingdom, with a population of just under 9 million. It stands on the River Thames in south-east England at the head of a estuary down to the North Sea, and has been a majo ...
prior to the United Kingdom's vote for withdrawal from the European Union, relocating to
Amsterdam Amsterdam ( , , , lit. ''The Dam on the River Amstel'') is the Capital of the Netherlands, capital and Municipalities of the Netherlands, most populous city of the Netherlands, with The Hague being the seat of government. It has a population ...
in March 2019.


2004: Renaming

Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).


2019: Relocation

Following the 2016 decision of the
United Kingdom The United Kingdom of Great Britain and Northern Ireland, commonly known as the United Kingdom (UK) or Britain, is a country in Europe, off the north-western coast of the continental mainland. It comprises England, Scotland, Wales and North ...
to leave the European Union ("
Brexit Brexit (; a portmanteau of "British exit") was the withdrawal of the United Kingdom (UK) from the European Union (EU) at 23:00 GMT on 31 January 2020 (00:00 1 February 2020 CET).The UK also left the European Atomic Energy Community (EAEC or ...
"), the EMA chose to search for another base of operations. According to EU Law the
European Commission The European Commission (EC) is the executive of the European Union (EU). It operates as a cabinet government, with 27 members of the Commission (informally known as "Commissioners") headed by a President. It includes an administrative body o ...
had to decide on the fate of the EMA's location. The EU ministers met to vote on their preferred successor. The EU's Health Commissioner
Vytenis Andriukaitis Vytenis Povilas Andriukaitis (born 9 August 1951) is WHO Special Envoy for the European region, the former European Commissioner for Health and Food Safety, a heart surgeon, a co-signatory to the 1990 Act of the Re-Establishment of the State of ...
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 Austria, , bar, Östareich officially the Republic of Austria, is a country in the southern part of Central Europe, lying in the Eastern Alps. It is a federation of nine states, one of which is the capital, Vienna, the most populous ...
,
Belgium Belgium, ; french: Belgique ; german: Belgien officially the Kingdom of Belgium, is a country in Northwestern Europe. The country is bordered by the Netherlands to the north, Germany to the east, Luxembourg to the southeast, France to th ...
,
Bulgaria Bulgaria (; bg, България, Bǎlgariya), officially the Republic of Bulgaria,, ) is a country in Southeast Europe. It is situated on the eastern flank of the Balkans, and is bordered by Romania to the north, Serbia and North Macedon ...
,
Croatia , image_flag = Flag of Croatia.svg , image_coat = Coat of arms of Croatia.svg , anthem = "Lijepa naša domovino"("Our Beautiful Homeland") , image_map = , map_caption = , capit ...
,
Cyprus Cyprus ; tr, Kıbrıs (), officially the Republic of Cyprus,, , lit: Republic of Cyprus is an island country located south of the Anatolian Peninsula in the eastern Mediterranean Sea. Its continental position is disputed; while it is geo ...
,
Czech Republic The Czech Republic, or simply Czechia, is a landlocked country in Central Europe. Historically known as Bohemia, it is bordered by Austria to the south, Germany to the west, Poland to the northeast, and Slovakia to the southeast. The ...
,
Denmark ) , song = ( en, "King Christian stood by the lofty mast") , song_type = National and royal anthem , image_map = EU-Denmark.svg , map_caption = , subdivision_type = Sovereign state , subdivision_name = Danish Realm, Kingdom of Denmark ...
,
Finland Finland ( fi, Suomi ; sv, Finland ), officially the Republic of Finland (; ), is a Nordic country in Northern Europe. It shares land borders with Sweden to the northwest, Norway to the north, and Russia to the east, with the Gulf of B ...
,
France France (), officially the French Republic ( ), is a country primarily located in Western Europe. It also comprises of Overseas France, overseas regions and territories in the Americas and the Atlantic Ocean, Atlantic, Pacific Ocean, Pac ...
,
Germany Germany,, officially the Federal Republic of Germany, is a country in Central Europe. It is the second most populous country in Europe after Russia, and the most populous member state of the European Union. Germany is situated betwe ...
,
Greece Greece,, or , romanized: ', officially the Hellenic Republic, is a country in Southeast Europe. It is situated on the southern tip of the Balkans, and is located at the crossroads of Europe, Asia, and Africa. Greece shares land borders with ...
,
Hungary Hungary ( hu, Magyarország ) is a landlocked country in Central Europe. Spanning of the Carpathian Basin, it is bordered by Slovakia to the north, Ukraine to the northeast, Romania to the east and southeast, Serbia to the south, Croatia a ...
,
Ireland Ireland ( ; ga, Éire ; Ulster Scots dialect, Ulster-Scots: ) is an island in the Atlantic Ocean, North Atlantic Ocean, in Northwestern Europe, north-western Europe. It is separated from Great Britain to its east by the North Channel (Grea ...
,
Italy Italy ( it, Italia ), officially the Italian Republic, ) or the Republic of Italy, is a country in Southern Europe. It is located in the middle of the Mediterranean Sea, and its territory largely coincides with the homonymous geographical re ...
,
Malta Malta ( , , ), officially the Republic of Malta ( mt, Repubblika ta' Malta ), is an island country in the Mediterranean Sea. It consists of an archipelago, between Italy and Libya, and is often considered a part of Southern Europe. It lies ...
, the
Netherlands ) , anthem = ( en, "William of Nassau") , image_map = , map_caption = , subdivision_type = Sovereign state , subdivision_name = Kingdom of the Netherlands , established_title = Before independence , established_date = Spanish Netherl ...
,
Poland Poland, officially the Republic of Poland, is a country in Central Europe. It is divided into 16 administrative provinces called voivodeships, covering an area of . Poland has a population of over 38 million and is the fifth-most populous ...
,
Portugal Portugal, officially the Portuguese Republic ( pt, República Portuguesa, links=yes ), is a country whose mainland is located on the Iberian Peninsula of Southwestern Europe, and whose territory also includes the Atlantic archipelagos of ...
,
Romania Romania ( ; ro, România ) is a country located at the crossroads of Central Europe, Central, Eastern Europe, Eastern, and Southeast Europe, Southeastern Europe. It borders Bulgaria to the south, Ukraine to the north, Hungary to the west, S ...
,
Slovakia Slovakia (; sk, Slovensko ), officially the Slovak Republic ( sk, Slovenská republika, links=no ), is a landlocked country in Central Europe. It is bordered by Poland to the north, Ukraine to the east, Hungary to the south, Austria to the s ...
,
Slovenia Slovenia ( ; sl, Slovenija ), officially the Republic of Slovenia (Slovene: , abbr.: ''RS''), is a country in Central Europe. It is bordered by Italy to the west, Austria to the north, Hungary to the northeast, Croatia to the southeast, an ...
,
Spain , image_flag = Bandera de España.svg , image_coat = Escudo de España (mazonado).svg , national_motto = ''Plus ultra'' (Latin)(English: "Further Beyond") , national_anthem = (English: "Royal March") , i ...
, and
Sweden Sweden, formally the Kingdom of Sweden,The United Nations Group of Experts on Geographical Names states that the country's formal name is the Kingdom of SwedenUNGEGN World Geographical Names, Sweden./ref> is a Nordic country located on ...
. It had also been speculated that the
Strasbourg Strasbourg (, , ; german: Straßburg ; gsw, label=Bas Rhin Alsatian, Strossburi , gsw, label=Haut Rhin Alsatian, Strossburig ) is the prefecture and largest city of the Grand Est region of eastern France and the official seat of the Eu ...
-based seat for the
European Parliament The European Parliament (EP) is one of the legislative bodies of the European Union and one of its seven institutions. Together with the Council of the European Union (known as the Council and informally as the Council of Ministers), it adopts ...
could be moved to Brussels, in exchange for the city to host the EMA. Others speculated on the merits of Amsterdam, well before the final decision was made. The decision on the relocation was made on 20 November 2017, during the EU
General Affairs Council The General Affairs Council is a configuration of the Council of the European Union and meets once a month. Meetings bring together the Foreign Ministers of the Member States. Ministers responsible for European Affairs also participate depending o ...
meeting, after three voting rounds and finally drawing of lots. After the first round of voting,
Milan Milan ( , , Lombard: ; it, Milano ) is a city in northern Italy, capital of Lombardy, and the second-most populous city proper in Italy after Rome. The city proper has a population of about 1.4 million, while its metropolitan city h ...
(25 votes),
Amsterdam Amsterdam ( , , , lit. ''The Dam on the River Amstel'') is the Capital of the Netherlands, capital and Municipalities of the Netherlands, most populous city of the Netherlands, with The Hague being the seat of government. It has a population ...
(20 votes) and
Copenhagen Copenhagen ( or .; da, København ) is the capital and most populous city of Denmark, with a proper population of around 815.000 in the last quarter of 2022; and some 1.370,000 in the urban area; and the wider Copenhagen metropolitan ar ...
(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. 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 Zuidas district was finalised.


Criticism

The review process of the European Medicines Agency regarding medical issues has been criticized for its lack of transparency. 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.


Comparison with other regulatory agencies

The EMA is roughly parallel to the drug part of the U.S.
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(FDA), but without
centralisation Centralisation or centralization (see spelling differences) is the process by which the activities of an organisation, particularly those regarding planning and decision-making, framing strategy and policies become concentrated within a particu ...
. 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.


See also

*
Ethics Committee An ethics committee is a body responsible for ensuring that medical experimentation and human subject research are carried out in an ethical manner in accordance with national and international law. Specific regions An ethics committee in the E ...
*
EudraCT EudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European clinical trials registry, Clinical Trials Database of all clinical trials of investigational medicinal products with at least one site in the European Union commen ...
*
EudraGMP EudraGMP is the database of the European Community of manufacturing authorisations and of certificates of good manufacturing practice. The EudraGMP system was launched in April 2007, for use by European Medicines Regulators. Access for the general ...
*
EudraLex EudraLex is the collection of rules and regulations governing medicinal products in the European Union. Volumes EudraLex consists of 10 volumes: *Concerning Medicinal Products for Human use: **Volume 1 - Pharmaceutical Legislation. **Volume 2 - ...
*
EUDRANET EUDRANET, the European Telecommunication Network in Pharmaceuticals (European Union Drug Regulating Authorities Network), is an IT platform to facilitate the exchange of information between regulatory partners and industry during submission and eval ...
*
EudraPharm EudraPharm (European Union Drug Regulating Authorities Pharmaceutical Database) was the database of medicinal products authorised in the European Union, and included the information contained in the Summary of Product Characteristics, the patient ...
*
EudraVigilance EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is the European data processing network and management system for reporting and evaluation of suspected adverse reactions to medicines which have been authorised or bein ...
*
European and Developing Countries Clinical Trials Partnership European, or Europeans, or Europeneans, may refer to: In general * ''European'', an adjective referring to something of, from, or related to Europe ** Ethnic groups in Europe ** Demographics of Europe ** European cuisine, the cuisines of Europe a ...
*
European Centre for Disease Prevention and Control The European Centre for Disease Prevention and Control (ECDC) is an agency of the European Union (EU) whose mission is to strengthen Europe's defences against infectious diseases. It covers a wide spectrum of activities, such as: surveillance, e ...
(ECDC) *
European Clinical Research Infrastructures Network The Framework Programmes for Research and Technological Development, also called Framework Programmes or abbreviated FP1 to FP9, are funding programmes created by the European Union/European Commission to support and foster research in the Europea ...
*
European Federation of Pharmaceutical Industries and Associations The European Federation of Pharmaceutical Industries and Associations (EFPIA) is a Brussels-based trade association and lobbying organisation, founded in 1978 and representing the research-based pharmaceutical industry operating in Europe. Throug ...
*
European Forum for Good Clinical Practice The European Forum for Good Clinical Practices (EFGCP) is a European think tank which works on the ethical, regulatory, and scientific framework of clinical research in Europe. The EFGCP is committed to the development of the standards for the prot ...
(EFGCP) * ICH *
Inverse benefit law The inverse benefit law states that the ratio of benefits to harms among patients taking new drugs tends to vary inversely with how extensively a drug is marketed. Two Americans, Howard Brody and Donald Light, have defined the inverse benefit law ...
*
Medicines and Healthcare products Regulatory Agency The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably ...
(MHRA, UK) * Qualified person *
Regulation of therapeutic goods The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are reg ...
* Supplementary protection certificate (SPC)


References


Further reading

*


External links

*
EMA Annual Report 2018

Heads of Medicines Agencies


(EudraLex)

official public health portal of the European Union {{Authority control 1993 in the European Union Agencies of the European Union European medical and health organizations Government agencies established in 1993 International organisations based in the Netherlands Medical and health organisations based in the Netherlands National agencies for drug regulation Organisations based in Amsterdam Regulators of biotechnology products Regulation in the European Union Health and the European Union