emea

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04/12/23 www.PharmInfopedia.com

StructureThe 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 StatementDeveloping efficient and transparent proceduresControlling 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 researchMobilising and coordinating scientific resources

from throughout the EU to provide high-quality evaluation of medicinal products

To advise on research and development programmesTo perform inspectionsTo provide useful and clear information to users

and healthcare professionals.


Organigramme


Management Board A ChairmanTwo members of European parliament European commissionTwo representatives of Patients' organizations Doctors' organizations Veterinarians' organizationsOne representative of each member

countryOne representative of observer countries04/12/23 www.PharmInfopedia.com

25 Member countries1. Austria2. Belgium3. Cyprus4. Czech Republic5. Denmark6. Estonia7. Finland8. France9. Germany10. Greece11. Hungary12. Ireland13. Italy14. Latvia15. Lithuania16. Luxembourg17. Malta18. Netherlands19. Poland20. Portugal21. Slovakia22. Slovenia23. Spain24. Sweden25. United Kingdom


Observer countries (EEA-EFTA States)

BulgariaIcelandLiechtensteinNorwayRomania


EMEA CommitteesCommittee for Medicinal Products for Human Use (CHMP)

The CHMP is composed ofA 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.


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.


EMEA CommitteesCommittee for Medicinal Products for

Veterinary Use (CVMP)The CVMP compositionRoles and responsibilities


EMEA CommitteesCommittee for Orphan Medicinal Products

(COMP)The COMP is composed ofA 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 recommendationOne European Commission representativeGeneral observers04/12/23 www.PharmInfopedia.com

EMEA CommitteesCommittee for Orphan Medicinal Products (COMP)

Role and responsibilitiesThe 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)CompositionOne 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 2006


EMEA CommitteesCommittee on Herbal Medicinal Products (HMPC)

Role and responsibilitiesAssisting 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 products04/12/23 www.PharmInfopedia.com

Product informationHuman MedicinesVeterinary MedicinesSafety AnnouncementsProduct WithdrawalsSummary of OpinionsOpinions for Orphan DesignationOpinions for medicines used outside the EU


EMEA Interaction with Patients' and Consumers' OrganisationsAgency 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: [email protected]


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 [email protected]/12/23 www.PharmInfopedia.com

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.


InspectionsEMEA Certificates of Medicinal ProductsThe EMEA certification scheme is based on

World Health Organisation recommendationsEMEA 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)04/12/23 www.PharmInfopedia.com

InspectionsGood 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 04/12/23 www.PharmInfopedia.com

InspectionsGood Clinical Practice - veterinary medicinal

productsFor clinical trials of veterinary products, Europe has

adopted the VICH GCPIt 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. 04/12/23 www.PharmInfopedia.com

InspectionsGood Manufacturing PracticeGood 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.


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.04/12/23 www.PharmInfopedia.com

RecruitmentRecruitment PolicyJob Opportunities


RecruitmentThis section gives detailed information for the

selection of various members of working committees.

EligibilityExperienceLinguistic requirementsApplication formSelection proceduresData protectionAppeal procedureReserve list and requirementsRecruitment policies04/12/23 www.PharmInfopedia.com

Meetings & events... EMEA CalendarConferences & Events


EU EnlargementThe 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 LegislationThese 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


EMEA Implementation of the New EU Pharmaceutical LegislationNew name for the EMEAAs 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.


EMEA Implementation of the New EU Pharmaceutical LegislationNew composition of the Management BoardPreviously 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. 04/12/23 www.PharmInfopedia.com

EMEA Implementation of the New EU Pharmaceutical LegislationNew composition of CHMP and CVMPNow 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.


EMEA Implementation of the New EU Pharmaceutical LegislationNew scientific committee: HMPCThe 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.


EMEA Implementation of the New EU Pharmaceutical LegislationNew 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.04/12/23 www.PharmInfopedia.com

EMEA Implementation of the New EU Pharmaceutical LegislationNew 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. 04/12/23 www.PharmInfopedia.com

EMEA Road Map to 2010European 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 CircusCanary WharfLondonE14 4HBUnited Kingdom

Telephone switchboard:(44-20) 74 18 84 00

Web site: www.emea.eu.int 04/12/23 www.PharmInfopedia.com

Contacting the EMEA by e-mail...General enquiries: [email protected] enquiries: [email protected]

E-mail addresses for EMEA staff members are constructed as follows:

[email protected]


REFERENCEhttp://www.emea.eu.int/


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