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发帖数: 25265 | 1 European Medicines Agency
The European Medicines Agency (EMA) is a European 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.[1]
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.[
citation needed]
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.
Contents
[hide]
1 Operations
2 Centralized marketing authorizations and CHMP/CVMP
3 Other Committees
4 Other activities
5 See also
6 References
7 External links
[edit] Operations
The European Medicines Agency operates as a decentralized 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 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.
[edit] 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 (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.
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.[2]
[edit] Other Committees
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 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).
[edit] Other activities
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.
[edit] See also
Ethics Committee
EudraCT
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
Medicines and Healthcare products Regulatory Agency (MHRA, UK)
Qualified Person
Regulation of therapeutic goods
Supplementary protection certificate (SPC)
[edit] References
^ 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
currently has no official acronym but may reconsider if EMA becomes commonly
accepted (see communication on new visual identity and logo).
^ Sherwood, Ted (16 April 2008). "Generic Drugs: Overview of ANDA Review
Process". CDER Forum for International Drug Regulatory Authorities. Food
and Drug Administration, Office of Pharmaceutical Science. Retrieved 30
January 2010.
McCormick, John (2004). The European Union: Politics and Policies.
Boulder, Colo: Westview Press. ISBN 0-8133-4202-3.
[edit] External links
Official website
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 |
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