European Medicine Agency

1. EUROPEAN MEDICINE
AGENCY
Prachi Sharma
M.Pharm. (DRA)
II Sem

2. Table of Content
• Introduction
• History
• Regulated and Non Regulated Areas
• Organization of EMA
• Committees of EMA
• EDQM
• General Guidelines (EudraLex)
• ASMF
• IMPD

3. Introduction
• The European Medicines Agency (or EMA) is the regulatory body in Europe
that ensures that medicines are safe and that they work as expected.
• Located in London, the Agency is responsible for both human and veterinary
medicines and has an important role in protecting public health in the EU.
• Working together with the national authorities of the 28 EU Member States as
well as Iceland, Norway and Lichtenstein, the Agency is a key part of the
European regulatory system for medicines.
• EMA serves about 500 million people living in EU.

4. • EMA was founded in 1995 and has a 25 years of track record of
ensuring safety and efficacy of human and vet medicines across
Europe, and in promoting research and innovation in medicine
development.
• In first 2 decades, the EMA authorized 975 human and 188 veterinary
medicines.
• In 2015, on its 20th anniversary, the agency produced an anniversary
book that captures the agency’s important progress in regulatory
science.
History

5. What does EMA regulate?
• Facilitates development and timely patient access to medicines
• Monitors the safety of medicine across its lifecycle
• Provides information to healthcare professional and patients

6. What the EMA does not regulate?
• Pricing of medicines
• Advertising of medicines
• Patents on medicines
• Medical Devices
• Cosmetics
• Food Supplements
• Homeopathic medicines

7. Organization of EMA
Under the supervision of Executive Director of EMA, Ms. Emer Cooke,
the following divisions are in function:
• Human Medicines Division
• Veterinary Medicines Division
• Information Management Division
• Administration ad Corporate Management Division
• Stakeholders and Communication Division

8. Committees of EMA
EMA comprises 7 scientific committees:
1. Committee for Medicinal Products for Human Use (CHMP):
publishes European Public Assessment Report for every medicine
with a granted marketing authorization.
2. Pharmacovigilance Risk Assessment Committee: designs and
evaluates the post marketing safety studies and PV audits.
1. Committee for Medicinal Products for Veterinary Use: establishes
the maximum residual limits of vet medicines permissible in food
produced by or from animals for human consumption.

9. 4. Committee for Orphan Medicinal Products: Advises the European
Commission on development of policy on orphan drugs.
5. Committee on Herbal Medicinal Products: assists in harmonizing
the herbal products concerned procedures and provisions.
6. Committee for Advanced Therapies: assesses the quality safety, and
efficacy of advanced therapy medicinal products.
7. Pediatric Committee: assesses the contents of pediatric investigation
plan as per Pediatric Regulations EC/ 1901/2006.

10. EDQM
• European Directorate for Quality Medicines is an organization that
protects the public health by enabling the development, supporting
the implementation and monitoring the application of quality
standards for medicines and their safe use.
• Founded in 1949, the directorate aids in development of European
Common and directorate principles.
Objectives of EDQM:
Provide authoritative quality standards for medicines
Responds rapidly to new public health risks
Facilitates access to high quality medicines

11. Organization of EDQM
Under the supervision director Ms. Petra Dorr, the EDQM functions in
following domains:
• Quality and Environment Unit
• Department of European Pharma
• Department pf Publication and Multimedia
• Department of Network Biologics Standards & Healthcare
• Department of Laboratory
• Division of Certificate of Substances
• Public Relations & Documentation Division
• Administration & Finance Division

12. General Guidelines (Eudralex)
• The European Union Drug Legislation Medicinal Products for Human
Use is the collection of rules and legislations that govern the
medicinal products in EU.
• Eudralex comprises of 10 volumes, as described below:
Volume 1: Pharmaceutical Legislations
Volume 2: Notice to Applicants
Volume 2A (procedure for MA)
Volume 2B (presentation and content of dossier)
Volume 2C (deals with guidelines)

13. Volume 3: Guidelines
Volume 4: GMP
Volume 5: Pharmaceutical Legislations
Volume 6: Notice to Applicants
Volume 7: Guidelines
Volume 8: Maximum Residual Limits
Volume 9: Pharmacovigilance
Volume 10: Clinical Trials

14. ASMF
Active Substance Master File is a set of documents that protects the
valuable confidential intellectual property of the manufacturer.
It provides the health authorities with the complete information of the
active substance used in a drug product to evaluate the suitability for
the product.
An ASMF is submitted to support the MAA for:
• New active substances
• Already existing active substances, excluded from European
Pharmacoepoeia

15. ASMF contains all the scientific information related to active substance.
It is divided into 2 parts:
1. Applicant Part (information considered to be non confidential by
the MAH)
2. Restricted Part (contains confidential information)
Any change to the ASMF should be reported by every MA holder to the
relevant National Competent Authority/EMA by means of an
appropriate variation procedure. A Submission Letter should be
provided (Annex 3).

16. IMPD
• The Investigational Medicinal Product Dossier forms the basis for
approval of clinical trials by competent authorities in the EU.
• An IMPD contains all the information about the quality, production
and control of the medicinal product that is being researched.
• The IMPD is divided into 4 sections:
Quality, Manufacturing and Control of IMP
Non clinical studies conducted with IMP
Clinical Use of IMP
Overall risk benefit assessment of an IMP in proposed trials

17. • An IMPD is submitted as a part of Clinical Trial Application Dossier,
equivalent to INDA in the US.
• It also forms the basis for support of MAA.
• The CTs Directive 2001/20/EC harmonizes the laws, regulations, and
administrative provisions of Member States related to
implementation of GCP in conducting CTs on medicinal products for
human use.
• The data in an IMPD is logically structured and follows the headings of
CTD along with the amount of information depending on product
type, indication, and development phase.

18. THANK
YOU