EMEA

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03/22/15 www.PharmInfopedia.com

StructureThe EMEA began its activities in 1995.
Decentralised body of the European Union - headquarters in
London.
25 EU Member States in a network of 42 national competent
authorities
Aim: Protection and promotion of public and animal health, through
the evaluation and supervision of medicines for human and veterinary
use
Coordinates the evaluation and supervision of medicinal products
throughout the European Union.
Centralised procedure - one single marketing authorisation
application
If the relevant Committee concludes that quality, safety and efficacy
of the medicinal product is sufficiently proven, it adopts a positive
opinion.
This is sent to the Commission to be transformed into a single market
authorisation valid for the whole of the European Union.

EMEA Mission Statement
Developing efficient and transparent procedures
Controlling the safety of medicines for humans and
animals, in particular through a pharmacovigilance
network and the establishment of safe limits for residues
in food-producing animals,
Facilitating innovation and stimulating research
Mobilising 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
To provide useful and clear information to users and
healthcare professionals.

Organigramme

Management Board
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

25 Member countries1. Austria
2. Belgium
3. Cyprus
4. Czech Republic
5. Denmark
6. Estonia
7. Finland
8. France
9. Germany
10. Greece
11. Hungary
12. Ireland
13. Italy
14. Latvia
15. Lithuania
16. Luxembourg
17. Malta
18. Netherlands
19. Poland
20. Portugal
21. Slovakia
22. Slovenia
23. Spain
24. Sweden
25. United Kingdom

Observer countries
(EEA-EFTA States)
Bulgaria
Iceland
Liechtenstein
Norway
Romania

EMEA CommitteesCommittee for Medicinal Products for Human Use
(CHMP)
The CHMP is composed of
A chairman, elected by serving CHMP members
One member (and an alternate) nominated by each of the
25 EU Member States
One member (and an alternate) nominated by each of the
EEA-EFTA states Iceland and Norway
Up to five co-opted members, chosen among experts
nominated by Member States or the EMEA and recruited,
when necessary, to gain additional expertise in a particular
scientific area.03/22/15 www.PharmInfopedia.com

EMEA CommitteesCommittee for Medicinal Products for Human Use (CHMP)
Role and responsibilities
 Assessment of medicinal products for which a Community-wide marketing
authorisation is sought
 Responsible for several post-authorisation and maintenance activities
 Arbitrates in cases where there is a disagreement between Member States
concerning the marketing authorisation of a particular medicinal product
 Assessments conducted by the CHMP are based on purely scientific criteria
 These processes ensure that medicinal products have a positive risk-benefit
balance
 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
authorisation 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 authorised 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.03/22/15 www.PharmInfopedia.com

EMEA Committees
Committee for Medicinal Products for Veterinary
Use (CVMP)
The CVMP composition
Roles and responsibilities

EMEA CommitteesCommittee for Orphan Medicinal Products (COMP)
The COMP is composed of
A chairman, elected by serving COMP members;
One member nominated by each of the 25 EU Member
States;
One member nominated by each of the EEA-EFTA states
(Iceland, Liechtenstein and Norway)
Three members nominated by the European Commission
To represent patients' organisations
On the EMEA's recommendation
One European Commission representative
General observers

EMEA CommitteesCommittee for Orphan Medicinal Products (COMP)
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 life-threatening 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.

EMEA CommitteesCommittee on Herbal Medicinal Products (HMPC)
Composition
One member and one alternate member from each of
the EU Member States and EEA-EFTA states.
The HMPC is composed of scientific experts in the
field of herbal medicinal products.
Currently, the Committee has co-opted members
with expertise in clinical pharmacology,
experimental/non-clinical pharmacology, toxicology
and paediatric medicines. A member with expertise
in traditional herbal medicines may be co-opted in

EMEA CommitteesCommittee on Herbal Medicinal Products
(HMPC)
Assisting 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.
Provides EU Member States and European
institutions its scientific opinion on questions
relating to herbal medicinal products

Product information
Human Medicines
Veterinary Medicines
Safety Announcements
Product Withdrawals
Summary of Opinions
Opinions for Orphan Designation
Opinions for medicines used outside the EU

EMEA Interaction with Patients' and
Consumers' OrganisationsAgency together with the EMEA/CHMP Working
Group with Patients' Organisations prepared a set
of criteria to be fulfilled by patients’ and
consumers’ organisations prior to involvement in
the EMEA activities.
Based on these criteria, a questionnaire has been
prepared to collect all necessary information in
order to evaluate if your organisation fulfils the
defined criteria, and therefore can be involved in
EMEA activities.
One can contact EMEA through this e-mail ID:
patients-consumers@emea.eu.int03/22/15 www.PharmInfopedia.com

SME Office: Addressing the needs of small
and medium-sized enterprises (SMEs)
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.
The Agency has launched an 'SME Office', which is
dedicated to addressing the particular needs of smaller
companies.
Any queries, feedback or comments are welcome.
Contact point smeoffice@emea.eu.int

Inspections - Activities of the Sector Coordination of the verification of compliance with the principles of Good
Manufacturing Practice (GMP), Good Clinical Practice (GCP) and Good
Laboratory Practice (GLP)
 Co-ordinating any inspection requested by the CHMP or CVMP
 Pharmacovigilance (PhV)
 Vaccine Antigen Master File (VAMF) and Plasma Master File (PMF)
certification.
 The Sector organises and chairs regular meetings of European Economic Area
(EEA) GCP and GMP inspectors
 Implications of PAT
 Sampling and Testing Programme.
 Communication and action by Member States in response to suspected
Quality Defects
 Responsibility for issuing Certificates of Medicinal Products in accordance
with WHO requirements
Whilst 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.

Inspections
EMEA Certificates of Medicinal Products
The EMEA certification scheme is based on
World Health Organisation recommendations
EMEA Certificates are issued by EMEA, on behalf
of the European Commission, to confirm the
Marketing Authorisation status of products
EMEA issues certificates within 10 working days
following receipt of a valid application form.

InspectionsCounterfeit 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
 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 antivirals.
 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)

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, consistent with the principles
that have their origin in the Declaration of Helsinki, and that the
clinical trial data are credible.
Clinical trials included in any marketing authorisation 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

Inspections
Good Clinical Practice - veterinary medicinal products
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 organisations 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).

InspectionsGood Laboratory Practice
The principles of Good Laboratory Practice (GLP) define a
set of rules and criteria for a quality system concerned
with the organisational 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 co-ordination of GLP
inspections of the non-clinical safety, toxicological and
pharmacological studies proposed in human and
veterinary applications for marketing authorisations under
the centralised system.
EMEA Inspections Sector has advised the CHMP and
CVMP that pivotal studies for centralised products should
be inspected to assess their compliance with the Principles
of GLP.

Inspections
Good Manufacturing Practice
Good Manufacturing Practice (GMP) is defined as
“That part of Quality Assurance which ensures
that products are consistently produced and
controlled to the quality standards appropriate to
their intended use.”
The principles and guidelines for GMP are stated
in two Directives; Directive for medicinal
products and investigational medicinal products
for human use and Directive concerning
veterinary medicinal products

InspectionsProcess Analytical Technology
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".
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
In order to support the PAT activities in EU, an EMEA PAT team was
created in November 2003.
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.03/22/15 www.PharmInfopedia.com

InspectionsProduct Defects and Recalls
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 batch(es) of a medicinal
product during its marketing period.
The authorisation holder is required to notify the relevant
Competent Authority of any defect or abnormal restriction
that could result in a recall.
Competent Authorites 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

InspectionsSampling and Testing of Centrally Authorised Products
The EMEA implements every year a sampling and testing
programme, aimed at supervising the quality of the
Centrally Authorised Products (CAPs) available on the
European market.
EMEA is supported by other institutional partners and by
the marketing authorisation holders; each of these plays
an important role in the success of the programmes.
Annual reports on the outcome of the sampling and
testing programme have been published starting with
products submitted for testing in 2003.

InspectionsInspection Fees
 An applicant for a marketing authorisation under the centralised procedure
(or for a variation to an existing marketing authorisation) is liable to pay a fee
for each inspection.
 A separate, full inspection fee of €17,400 is charged for each distinct
inspection of an individual site and €8,700 in the case of consecutive distinct
inspections.
 Invoices are issued within 20 days of the confirmation of the inspection dates
by the relevant inspectors and are sent by registered post to the applicant.
 To pay the total fee charged within 45 days from the date on which the
inspection is carried out.
 For inspections outside the Community the applicant is also required to pay
the travel and accommodation expenses of the Inspector(s) and any Experts
involved in carrying out the inspection(s). These expenses are to be paid
directly by the applicant to the inspectors’ Authorities.

Recruitment
Recruitment Policy
Job Opportunities

Recruitment
This section gives detailed information for the selection of
various members of working committees.
Eligibility
Experience
Linguistic requirements
Application form
Selection procedures
Data protection
Appeal procedure
Reserve list and requirements
Recruitment policies

Meetings & events...
EMEA Calendar
Conferences & Events

EU Enlargement
The EMEA has opened up a new area for this
topic with a view to providing information and
guidance to applicants and marketing
authorization holders during the run up to
accession of Bulgaria and Romania as of 1st
January 2007 and future candidate countries.
The intention is to provide a variety of
information on topics specific to the EMEA’s
activities and help applicants/marketing
authorization holders prepare for those phasing in
processes and transitional processes.

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

New name for the EMEA
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'.
The acronym 'EMEA', however, remains
unchanged.

New composition of the Management Board
Previously there were two representatives per Member State on the
Board, there is now only one.
Board will include two representatives of patients' organisations, one
representative of doctors' organisations and one representative of
veterinarians' organisations. The selection process for these
representatives is ongoing; it is expected that the full composition of
the Board will be settled shortly.
Management Board continues to have two representatives of the
European Parliament and two representatives of the European
Commission, plus one observer from each of the EEA-EFTA states
Iceland, Liechtenstein and Norway.
Each member of the Management Board has an alternate.

New composition of CHMP and CVMP
Now have one representative per EU Member
State instead of two, plus one representative for
Iceland and one representative for Norway.
Each committee member has an alternate.
Possibility of appointing up to five co-opted
members each, to gain additional expertise in
particular scientific areas.

New scientific committee: HMPC
The HMPC was inaugurated in September 2004.
The role of the HMPC is to provide the Member
States and the European Institutions with the best-
possible scientific opinions on questions relating to
herbal medicinal products.

New scientific advice working parties (SAWPs)
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.
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.03/22/15 www.PharmInfopedia.com

New scientific advisory groups (SAGs)
On request from the committee concerned, an
independent recommendation on scientific and technical
matters relating to products under evaluation.
Views expressed by the SAGs are taken into account, the
ultimate responsibility for final opinions rests with the
respective scientific committee.
SAGs to provide expertise on oncology, diagnostics, anti-
infectives and endocrinology/diabetes. The establishment
of SAGs for HIV/viral diseases, CNS/psychiatry, and
cardiology is planned for 2005/2006.

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.

Contacting the EMEA...
EMEA
7 Westferry Circus
Canary Wharf
LondonE14 4HB
United Kingdom
Telephone switchboard:
(44-20) 74 18 84 00
Web site: www.emea.eu.int

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

REFERENCE
http://www.emea.eu.int/

EMEA

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