EMA

Question 1

Key roles of EMA

Scientific Advice

Answer 1

Provision of scientific advice on the development of medicines

Question 2

Key Roles of EMA

Orphan Designation

Answer 2

Evaluation of applications for orphan designation in EU

Question 3

Key Roles of EMA

Orphan Designation

Answer 3

Evaluation of applications for orphan designation in EU

Question 4

Key Roles of EMA

Paediatric Investigation Plans

Answer 4

Evaluation of paediatric investigation plans (or waivers)

Question 5

Key Roles of EMA

Evaluation of Marketing

Answer 5

Evaluation of marketing authorisation applications for human and veterinary medicines

Question 6

What does the EMA not control?

Answer 6

1 Pricing of medicines Ø Access to medicines 
2 Advertising of medicines 
3 Patents on medicines 
4 Medical devices 
5 Homoeopathic medicines 
6 Food supplements 
7 Cosmetics 
8 Tobacco

Question 7

National Competent Authorities

Answer 7

European Medicines Agency (EMA) works closely withnational competent authoritiesin a regulatory network. The Agency also implements policies and procedures to ensure it works independently, openly and transparently and upholds the highest standards in its scientific recommendations.

Question 8

EMA Committees

Answer 8

1 Committee for Medicinal Products for Human Use (CHMP)
2 Pharmacovigilance Risk Assessment Committee (PRAC)
3 Committee for Medicinal Products for Veterinary Use (CVMP)
4 Committee for Orphan Medicinal Products (COMP)
5 Committee on Herbal Medicinal Products (HMPC)
6 Committee for Advanced Therapies (CAT)
7 Paediatric Committee (PDCO)

Question 9

Experts Working with the Scientific Committees

Answer 9

See diagram