CRED 8 Presentations

01/07/2024

 Regulatory bodies: EMA and European Commission

9

The Organisation for Professionals in Regulatory Affairs

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”)

• 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