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List of content
 EMEA STRUCTURE
 EMEA MISSION STATEMENT
 EMEA COMMITTEE
MANAGEMENT BOARD
COMMITTEE FOR MEDICINAL
PRODUCTS FOR HUMAN USE
(CHMP)
COMMITTEE FOR MEDICAL
PRODUCTS FOR VETERINARY USE
(CVMP)
COMMITTEE FOR ORPHAN
MEDICINAL PRODUCTS (COMP)
COMMITTEE FOR HERBAL
MEDICINAL PRODUCT (HMPC)
 INSPECTIONS – ACTIVITIES OF SECTOR
 EMEA IMPLEMENTATION OF THE NEW
EU PHARMACEUTICAL LEGISLATION
 EMEA ROAD MAP TO 2010
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INTRODUCTION
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The EMEA began its activities in 1995, when the
European system for authorizing medicinal
products was introduced,
European Medicines Agency (EMEA) is a
decentralized body of the European Union with
headquarters in London.
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.
The Agency brings together the scientific resources
of the 25 EU Member States in a network of 42
national competent authorities.
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Conti…
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The EMEA has a role in both, but is primarily
involved in the centralized procedure.
Where the centralized procedure is used,
companies submit one single marketing
authorization application to the EMEA.
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).
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Conti…
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In 2001, the Committee on Orphan Medicinal
Products (COMP) was established, charged with
reviewing designation applications from persons
or companies who intend to develop medicines
for rare diseases (so-called ‘orphan drugs’).
The Committee on Herbal Medicinal Products
(HMPC) was established in 2004 and provides
scientific opinions on traditional herbal
medicines.
The main responsibility of the Pediatric
Committee (PDCO) is to assess the content of
pediatric investigation plans and adopt opinions
on them in accordance with Regulation
A network of some 3,500 European experts
underpins the scientific work of the EMEA and
its committees.
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EMEA
organigramme
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EMEA Mission Statement
 Developing efficient and transparent procedures to
allow rapid access by users to safe and effective
innovative medicines and to generic and nonprescription medicines through a single European
marketing authorization
 Controlling the safety of medicines for humans and
animals,
 in particular through a pharmacovigilance
network
 the establishment of safe limits for residues in
food-producing animals,
 Facilitating innovation and stimulating research
 Mobilizing and coordinating scientific resources
from throughout the EU
 to provide high-quality evaluation of medicinal
products,
 to advise on research and development
programmes,
 to perform inspections and to provide useful and
clear
information to users and healthcare
professionals.
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EMEA committee
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Management Board
:: CHMP
:: CVMP
:: COMP
:: HMPC
:: PDCO
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Management Board
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A Chairman
Two members of
European parliament
European commission
Two representatives of
Patients' organizations
Doctors' organizations
Veterinarians' organizations
One representative of each member country
One representative of observer countries
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25 Member countries
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2.
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10.
11.
12.
13.
14.
15.
16.
17.
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22.
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24.
25.
Austria
Belgium
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Ireland
Italy
Latvia
Lithuania
Luxembourg
Malta
Netherlands
Poland
Portugal
Slovakia
Slovenia
Spain
Sweden
United Kingdom
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Observer countries
(EEA-EFTA States)
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Bulgaria
Iceland
Liechtenstein
Norway
Romania
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Committee for Medicinal Products
for Human Use (CHMP)
Role and responsibilities
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Responsible for several post-authorization and
maintenance activities
Arbitrates in cases where there is a
disagreement between Member States
concerning the marketing authorization of a
particular medicinal product
Assessments conducted by the CHMP are based
on purely scientific criteria and determine
whether or not the products concerned meet the
necessary quality, safety and efficacy
requirements.
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These processes ensure that medicinal products
have a positive risk-benefit balance in favour of
patients/users of these products once they reach the
marketplace.
The CHMP plays an important role in this EU-wide
‘pharmacovigilance’ activity by closely monitoring
reports of adverse drug reaction reports, making
recommendations regarding changes to a product’s
marketing authorization or the product’s
suspension/withdrawal from the market.
Can issue an ‘urgent safety restriction’ (USR)
The CHMP publishes a European Public
Assessment Report (EPAR) for every centrally
authorized product that is granted a marketing
authorization
The EMEA’s integrated quality-management system
ensures effective planning, operation and control of
the CHMP’s processes and records.
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Other important activities of the CHMP
and its working parties include:
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The provision of assistance to companies
researching and developing new
medicines;
The preparation of scientific and
regulatory guidelines for the
pharmaceuticals industry;
Cooperation with international partners
on the harmonisation of regulatory
requirements for medicines.
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Committee for Medicinal Products for
Veterinary Use (CVMP)
Role and responsibilities
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Establishment of MRLs: the 'maximum residue
limits' of veterinary medicinal products
permissible in food produced by or from animals
for human consumption, including dairy
products, meat, honey etc.
These limits must be established for all
pharmacologically active substances contained in
a medicinal product before the product can be
granted a marketing authorization.
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Committee for Orphan Medicinal
Products (COMP)
Role and responsibilities
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The Committee for Orphan Medicinal Products
(COMP) is responsible for reviewing
applications from persons or companies seeking
'orphan medicinal product designation' for
products they intend to develop for the
diagnosis, prevention or treatment of lifethreatening or very serious conditions that
affect not more than 5 in 10,000 persons in the
European Union.
The COMP is also responsible for advising the
European Commission on the establishment
and development of a policy on orphan
medicinal products in the EU,
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Committee on Herbal Medicinal
Products (HMPC)
Role and responsibilities
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The HMPC's activities aim at assisting the
harmonization 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.
The HMPC provides EU Member States and
European institutions its scientific opinion on
questions relating to herbal medicinal products.
Other core tasks include the establishment of a
draft 'Community list of herbal substances,
preparations and combinations thereof for use in
traditional herbal medicinal products', as well as
the establishment of Community herbal
monographs.
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Pediatric Committee (PDCO)
Role and responsibilities
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Pediatric Committee (PDCO) is to assess the
content of pediatric investigation plans and adopt
opinions on them in accordance with Regulation
assessing data generated in accordance with agreed
pediatric investigation plans and adopting opinions
on the quality, safety or efficacy of any medicine
for use in the pediatric population (at the request
of the Committee for Medicinal Products for
Human Use or a competent authority)
survey on all existing uses of medicinal products in
the pediatric population
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Product information
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Human Medicines
Veterinary Medicines
Safety Announcements
Product Withdrawals
Summary of Opinions
Opinions for Orphan Designation
Opinions for medicines used outside the EU
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SME Office: Addressing the needs of small
and medium-sized enterprises (SMEs)
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Specific provisions aimed at promoting
innovation and the development of new medicinal
products for human and veterinary use by SMEs
were adopted by the European Commission on 15
December 2005.
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The Agency has launched an 'SME Office', which
is dedicated to addressing the particular needs of
smaller companies.
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Contact point: smeoffice@emea.eu.int
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Inspections - Activities of the Sector
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Coordination of the verification of compliance with
the principles of Good Manufacturing Practice
(GMP), Good Clinical Practice (GCP) and Good
Laboratory Practice (GLP)
Co-coordinating any inspection requested by the
CHMP or CVMP
Pharmacovigilance (PhV)
Vaccine Antigen Master File (VAMF) and Plasma
Master File (PMF) certification.
The Sector organizes and chairs regular meetings
of European Economic Area (EEA) GCP and GMP
inspectors
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Implications of PAT
Sampling and Testing Programmed.
Communication and action by Member States
in response to suspected Quality Defects
Responsibility for issuing Certificates of
Medicinal Products in accordance with WHO
requirements
While most scientific activities of the Agency are
divided between medicinal products for human
and for veterinary use, the tasks of the
Inspections Sector are typically common to
both types of products.
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Inspections
EMEA Certificates of Medicinal
Products
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The EMEA certification scheme is based on World
Health Organization (WHO) recommendations
EMEA Certificates are issued by EMEA, on behalf
of the European Commission, to confirm the
Marketing Authorization status of products
EMEA issues certificates within 10 working days
following receipt of a valid application form.
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Inspections
Counterfeit Medicines
 Counterfeit medicines are substandard
pharmaceuticals - medicines manufactured below
established standards of safety, quality and efficacy.
 Counterfeiting can apply to both branded and generic
products
 Counterfeit medicines may include products with
Correct ingredients but fake packaging
with the wrong ingredients
without active ingredients
with insufficient active ingredients.
 The most frequently counterfeited medicines in
wealthy countries
developing countries
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As the phenomenon spreads, more and more
medicines are counterfeited, including expensive
ones, such as anti-cancer drugs, and those highly in
demand, such as antiviral.
EMEA seeks to support anti-counterfeiting
activities in close cooperation with the Commission
and national medicines agencies by facilitating
information sharing and coordinating actions
(including recalls and testing)
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Inspections
Good Clinical Practice - Human
Medicinal Products
 Good Clinical Practice (GCP) is an international
ethical and scientific quality standard for
designing, recording and reporting trials that
involve the participation of human subjects.
 Compliance with this standard provides public
assurance that
the rights, safety and well being of trial
subjects are protected,
the clinical trial data are credible.
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Clinical trials included in any marketing
authorization application in the EU are required to
be conducted in accordance with GCP
The sector is involved in the preparation of new
and revised guidance on GCP topics, co-ordination
of advice on the interpretation of EU GCP
requirements and related technical issues, and on
the development of community-wide procedures
relating to GCP inspections.
Europe has adopted the ICH-GCP in July 1996
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Inspections
Good Clinical Practice - veterinary
medicinal products
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For clinical trials of veterinary products,
Europe has adopted the VICH GCP
It provides guidance on the design and conduct
of all clinical studies of veterinary products in
the target species.
It is directed at all individuals and
organizations involved in the design, conduct,
monitoring, recording, auditing, analysis and
reporting of clinical studies in target species
and is intended to ensure that such studies are
conducted and documented in accordance with
the principles of Good Clinical Practice (GCP).
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Inspections
Good Laboratory Practice
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The principles of Good Laboratory
Practice (GLP) define a set of rules and
criteria for a quality system concerned
with the organizational process and the
conditions under which non-clinical
health and environmental safety studies
are planned, performed, monitored,
recorded, reported and archived.
The Procedure describes the coordination of GLP inspections of the
non-clinical safety, toxicological and
pharmacological studies proposed in
human and veterinary applications for
marketing authorizations under the
centralized system.
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Inspections
Process Analytical Technology
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The term "Process Analytical Technologies
(PAT)" has been used to describe "a system for
designing and controlling manufacturing
through timely measurements (i.e. during
processing) of critical quality and performance
attributes for raw and in-process materials and
also processes with the goal of ensuring final
product quality".
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Focused on a comprehensive analysis of the
active substance, the choice of the composition,
the manufacturing method, as well as the
identification of the critical process parameters
and the development of suitable analytical
methods
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In order to support the PAT activities in EU, an
EMEA PAT team was created in November 2003.
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Aim to review the implications of PAT and to
ensure that the European regulatory framework
and the authorities are prepared for and
adequately equipped to conduct thorough and
effective evaluations of PAT-based submissions.
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Inspections
Product Defects and Recalls
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In order to protect public health and
animal health, it may become necessary
to implement urgent measures such as
the recall of one or more defective
batches of a medicinal product during its
marketing period.
Competent Authorities should ensure
that information concerning the recall of
medicinal products is notified rapidly to
other Member States, if the nature of the
defect presents a serious risk to public
health.
This information is communicated using
the Rapid Alert Procedure
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Inspections
Sampling and Testing of Centrally
Authorized Products
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The EMEA implements every year a
sampling and testing programme,
aimed at supervising the quality of the
Centrally Authorized Products (CAPs)
available on the European market.
Annual reports on the outcome of the
sampling and testing programme have
been published starting with products
submitted for testing in 2003.
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EMEA Implementation of the New EU
Pharmaceutical Legislation
These new provisions provide tools to speed up
patients’ and healthcare professionals’ access
to medicinal products in the Community.
They also introduce measures for better safety
monitoring of medicinal products for human
and veterinary use
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EMEA Implementation of the New EU
Pharmaceutical Legislation
New name for the EMEA
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As a consequence of the revised EU
pharmaceutical legislation, the name of the EMEA
changed from the 'European Agency for the
Evaluation of Medicinal Products' to the
'European Medicines Agency‘.
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The acronym 'EMEA', however, remains
unchanged.
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EMEA Implementation of the New EU
Pharmaceutical Legislation
New scientific advice working parties
(SAWPs)
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Providing scientific advice to undertakings on
the conduct of the various tests and trials
necessary to demonstrate the quality, safety and
efficacy of medicinal products.
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The CHMP and CVMP have each set up a
Scientific Advice Working Party to fulfil this
responsibility by providing scientific advice and
protocol assistance to sponsors, companies,
research institutes, etc.
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EMEA Implementation of the New EU
Pharmaceutical Legislation
New scientific advisory groups
(SAGs)
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On request from the committee
concerned, an independent
recommendation on scientific and
technical matters relating to products
under evaluation.
SAGs to provide expertise on oncology,
diagnostics, anti-infective and
endocrinology/diabetes HIV/viral
diseases, CNS/psychiatry, and
cardiology.
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EMEA Road Map to 2010
 European Medicines Agency (EMEA) has
developed a long-term strategy that will
contribute
 To better protection and promotion of
public and animal health,
 Improve the regulatory environment for
medicinal products, and
 Help to stimulate innovation, research and
development in the EU.
 The Road Map takes a realistic view of the
challenges facing the Agency and the EU
regulatory system as a whole, while offering
viable proposals as to how those challenges can
be met.
 On the solid achievements of the past 10 years,
the EMEA and its partners in the EU medicines
system adequately prepared the ground for
further success in the years to come.
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Contacting the EMEA by e-mail.
General enquiries: info@emea.eu.int
Press enquiries: press@emea.eu.int
E-mail addresses for EMEA staff
members are constructed as follows:
first-name.family-name@emea.eu.int
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REFERENCE
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http://www.emea.eu.int/
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