European Medicines Agency
Encyclopedia
The European Medicines Agency (EMA) is a Europe
an agency for the evaluation of medicinal products
. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.
Roughly parallel to the U.S. Food and Drug Administration
(FDA), but without FDA-style centralization
, the European Medicines Agency was set up in 1995 with funding from the European Union
and the pharmaceutical industry, as well as indirect subsidy from member states, in an attempt to harmonize (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 states
unwilling to approve new drugs that might compete with those already produced by domestic drug companies. The EU is currently the source of about one-third of the new drugs brought onto the world market each year.
Based in London
, the EMA was born 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.
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 authorized products and national referrals, developing technical guidance and providing 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, six scientific committees (human, veterinary and herbal medicinal products, orphan drugs, pediatrics and advanced therapies) and a number of scientific working parties. The Secretariat is organized 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 decentralizes
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.
For products eligible for or requiring centralized approval, a company submits an application for a marketing authorisation to the EMA. A single evaluation is carried out through the Committee for Medicinal Products for Human Use
(CHMP) or Committee for Medicinal Products for Veterinary Use (CVMP). If the relevant 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.
The CHMP and CVMP are 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. This compares well with the average of 500 days taken by the U.S. FDA
.
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 appplication and makes a recommendation for the designation which is then granted by the European Commission
.
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).
The Paediatric Committee (PDCO) deals with the implementation of the pediatric legislation in Europe Directive (EC) No 1901/2004 (since 2007). Under this legistation, all applications for marketing authorization of new medicinal products, or variations to existing authorizations, have to either include data from pediatric studies (previously agreed with the PDCO), or to demonstrate that a waiver or a deferral of these studies has been obtained from the PDCO.
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.
A seventh committee, the Pharmacovigilance Risk Assessment Committee (PRAC) is expected to come into function in 2012 with the implementation of the new EU pharmacovigilance legislation (Directive 2010/84/EU).
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.
Europe
Europe is, by convention, one of the world's seven continents. Comprising the westernmost peninsula of Eurasia, Europe is generally 'divided' from Asia to its east by the watershed divides of the Ural and Caucasus Mountains, the Ural River, the Caspian and Black Seas, and the waterways connecting...
an agency for the evaluation of medicinal products
Medication
A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease.- Classification :...
. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.
Roughly parallel to the U.S. Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA), but without FDA-style centralization
Centralization
Centralisation, or centralization , is the process by which the activities of an organisation, particularly those regarding planning and decision-making, become concentrated within a particular location and/or group....
, the European Medicines Agency was set up in 1995 with funding from the European Union
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
and the pharmaceutical industry, as well as indirect subsidy from member states, in an attempt to harmonize (but not replace) the work of existing national medicine
Medication
A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease.- Classification :...
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
Protectionism is the economic policy of restraining trade between states through methods such as tariffs on imported goods, restrictive quotas, and a variety of other government regulations designed to allow "fair competition" between imports and goods and services produced domestically.This...
tendencies of states
Sovereign state
A sovereign state, or simply, state, is a state with a defined territory on which it exercises internal and external sovereignty, a permanent population, a government, and the capacity to enter into relations with other sovereign states. It is also normally understood to be a state which is neither...
unwilling to approve new drugs that might compete with those already produced by domestic drug companies. The EU is currently the source of about one-third of the new drugs brought onto the world market each year.
Based in London
London
London is the capital city of :England and the :United Kingdom, the largest metropolitan area in the United Kingdom, and the largest urban zone in the European Union by most measures. Located on the River Thames, London has been a major settlement for two millennia, its history going back to its...
, the EMA was born 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.
Operations
The European Medicines Agency operates as a decentralized scientific agency (as opposed to a regulatory authority) of the European UnionEuropean Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
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 authorized products and national referrals, developing technical guidance and providing 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, six scientific committees (human, veterinary and herbal medicinal products, orphan drugs, pediatrics and advanced therapies) and a number of scientific working parties. The Secretariat is organized 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 decentralizes
Decentralization
__FORCETOC__Decentralization or decentralisation is the process of dispersing decision-making governance closer to the people and/or citizens. It includes the dispersal of administration or governance in sectors or areas like engineering, management science, political science, political economy,...
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.
Centralized marketing authorizations and CHMP/CVMP
The centralized procedure allow companies to submit a single application to the Agency to obtain from the European Commission a centralized (or ‘Community’) marketing authorization valid in all EU and EEA-EFTA states (Iceland, Liechtenstein and Norway). The centralized 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 centralized 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 centralized approval, a company submits an application for a marketing authorisation to the EMA. A single evaluation is carried out through the Committee for Medicinal Products for Human Use
Committee for Medicinal Products for Human Use
The Committee for Medicinal Products for Human Use , formerly known as Committee for Proprietary Medicinal Products , is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regarding medicinal products for human use.E.g.: In June 2007 the CHMP...
(CHMP) or Committee for Medicinal Products for Veterinary Use (CVMP). If the relevant 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
European Commission
The European Commission is the executive body of the European Union. The body is responsible for proposing legislation, implementing decisions, upholding the Union's treaties and the general day-to-day running of the Union....
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 authorisation
Paediatric-use marketing authorisations are granted by the European Medicines Agency for medical products that are intended exclusively for paediatric use, that is, for use in patients younger than 18 years...
(PUMA), which can be granted for medical products intended exclusively for paediatric use.
The CHMP and CVMP are 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. This compares well with the average of 500 days taken by the U.S. FDA
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
.
Other Committees
The Committee on Orphan Medicinal Products (COMP) administers the granting of orphan drugOrphan drug
An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease...
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 appplication and makes a recommendation for the designation which is then granted by the European Commission
European Commission
The European Commission is the executive body of the European Union. The body is responsible for proposing legislation, implementing decisions, upholding the Union's treaties and the general day-to-day running of the Union....
.
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).
The Paediatric Committee (PDCO) deals with the implementation of the pediatric legislation in Europe Directive (EC) No 1901/2004 (since 2007). Under this legistation, all applications for marketing authorization of new medicinal products, or variations to existing authorizations, have to either include data from pediatric studies (previously agreed with the PDCO), or to demonstrate that a waiver or a deferral of these studies has been obtained from the PDCO.
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
Gene therapy is the insertion, alteration, or removal of genes within an individual's cells and biological tissues to treat disease. It is a technique for correcting defective genes that are responsible for disease development...
, somatic cell
Somatic cell
A somatic cell is any biological cell forming the body of an organism; that is, in a multicellular organism, any cell other than a gamete, germ cell, gametocyte or undifferentiated stem cell...
therapy and tissue engineered
Tissue engineering
Tissue engineering is the use of a combination of cells, engineering and materials methods, and suitable biochemical and physio-chemical factors to improve or replace biological functions...
products. It assesses the quality, safety and efficacy of ATMPs, and follows scientific developments in the field.
A seventh committee, the Pharmacovigilance Risk Assessment Committee (PRAC) is expected to 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
Pharmacovigilance
Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines...
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.
See also
- Ethics CommitteeEthics Committee (European Union)The Ethics Committee, according to Directive 2001/20/EC, is an independent body in a Member State of the European Union, consisting of healthcare professionals and non-medical members, whose responsibility it is to protect the rights, safety and well being of human subjects involved in a clinical...
- EudraCTEudraCTEudraCT is the European Clinical Trials Database of all clinical trials commencing in the European Union from 1 May 2004 onwards...
- EudraLexEudraLexEudraLex 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....
- EUDRANETEUDRANETEUDRANET, the European Telecommunication Network in Pharmaceuticals , is an IT platform to facilitate the exchange of information between regulatory partners and industry during submission and evaluation of applications...
- EudraPharmEudraPharmEudraPharm is the database of medicinal products authorised in the European Union, and includes the information contained in the Summary of Product Characteristics, the patient or user package leaflet and the information shown on the labelling...
- EudraVigilanceEudraVigilanceEudraVigilance is the European data processing network and management system for reporting and evaluation of suspected adverse reactions during the development of new drugs and for following the marketing authorisation of medicinal products in the European Economic Area .The European...
- European and Developing Countries Clinical Trials PartnershipEuropean and Developing Countries Clinical Trials PartnershipThe European and Developing Countries Clinical Trials Partnership or EDCTP is a partnership between the European Union , Norway, Switzerland and developing countries and other donors, as well as the pharmaceutical industry, to enable clinical trials and the development of new medicines and vaccines...
- European Clinical Research Infrastructures Network
- European Federation of Pharmaceutical Industries and AssociationsEuropean Federation of Pharmaceutical Industries and AssociationsEuropean Federation of Pharmaceutical Industries and Associations is a Brussels-based trade union founded in 1978 representing the research-based pharmaceutical industry operating in Europe....
- European Forum for Good Clinical PracticeEuropean Forum for Good Clinical PracticeThe European Forum for Good Clinical Practices is a European think tank which works on the ethical, regulatory, and scientific framework of clinical research in Europe...
(EFGCP) - ICH
- Inverse benefit lawInverse benefit lawThe 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...
- Medicines and Healthcare products Regulatory AgencyMedicines and Healthcare products Regulatory AgencyThe Medicines and Healthcare products Regulatory Agency is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe....
(MHRA, UK) - Qualified PersonQualified PersonQualified Person is a technical term used in European Union pharmaceutical regulation...
- Regulation of therapeutic goodsRegulation of therapeutic goodsThe regulation of therapeutic goods, that is 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...
- Supplementary protection certificateSupplementary protection certificateIn European Union member countries, a supplementary protection certificate is a sui generis, extension of a patent under a specific, different, set of right. This type of right is available for medicinal products, such as drugs, and plant protection products, such as insecticides, and herbicides...
(SPC)
External links
- Committee for Medicinal Products for Human Use (CHMP)
- Committee for Medicinal Products for Veterinary Use (CVMP)
- Heads of Medicines Agencies
- Agencies of the European Union
- The Rules Governing Medicinal Products in the European Union (EudraLex)
- European Economic Area (EEA)
- Health-EU Portal official public health portal of the European Union