Module 1 2021

28/06/2021

EU EMA - Scientific Advice

• Centralized: CHMP advises on recommendation of Scientific Advice Working Party (SAWP) • Development strategies rather than pre-evaluation of data • Answers to questions posed by company • Formal process, timings and expectations • consider dates/deadlines for submission • Allows input from relevant organisations and experts • also consider opportunities to seek advice from HTAs • Advice is not legally binding but …..expected to be followed! • Achieves EU consensus for advice, valuable for a Centralised MAA • Resolves national differences? ….National views still significantly influence advice

The Organisation for Professionals in Regulatory Affairs

21

• Typically less formal, covers more ad hoc needs • Essential for resolution of local issues • Local guidelines and legislation • National processes, access, fees, formalities vary EU National Agency - Scientific Advice

• Valuable for assessing national views and understanding diversity of EU views – experienced as useful prior to seeking formal EU SA • Agreements/outcomes can be explored further • Excellent opportunities to build relationships • Derisk clinical trials and environmental risk assessment which are still national procedures

The Organisation for Professionals in Regulatory Affairs

22

11