CRED ERP 25

01/07/2025

⚫ Regulatory bodies: EMA and European Commission

The Organisation for Professionals in Regulatory Affairs 9

9

European Commission (1/2)

• Proposes EU legislation in the pharmaceutical field (EU Parliament and Council of the EU adopt legislation via so-called “Co - decision procedure”/Trilogue phase)

• Coordinates EU policy in the field

• Develops guidelines and coordinates Notice to Applicants (NtA) WG group (drafting/updating chapters of Volume 2A of NtA)

• Organizes pharmaceutical committee and expert groups

10

The Organisation for Professionals in Regulatory Affairs

10