Spring Intro 2023

03/03/2023

• Understand the role and structure of EMA

• Understand the circumstances in which the centralised procedure is used

• Gain a full understanding of the Marketing Authorisation process from start (pre-submission phase) to finish (post approval phase), with some handy tips and practical advice!

The Organisation for Professionals in Regulatory Affairs

3

Overview of EMA

European Medicines Agency (EMA)

EMA responsibility is the protection & promotion of public and animal health through the evaluation & supervision of medicines for human & veterinary use

Agency Staff (incl Task Forces)

Committee for medicinal products for veterinary use (CVMP)

Committee for medicinal products for human use (CHMP)

Each committee contains members nominated by the national competent authorities

Committee for advanced therapies (CAT)

Pharmacovi gilence risk assessment committee (PRAC)

Committee for orphan medicinal products (COMP)

Committee on herbal medicinal products (HMPC)

Paediatric committee (PDCO)

Preparation of scientific and regulatory guidelines for industry

Provision of advice to companies developing medicines (SAWP)

Working with international agencies to harmonise approaches

Monitoring of safety of authorised medicines

Scientific assessment of new medicines

The EMA is a scientific body with expertise required to assess the benefits and risks of medicines. However, it has no authority to permit marketing of medicines. The EMA makes recommendations to EU Commission Decision who then make final legally binding decision

30 National Agencies who each appoint a member and an alternate

EMA links: Homepage and Human medicines regulatory information

The Organisation for Professionals in Regulatory Affairs

4