CRED Understanding Clinical Development 2024

08/10/2024

Legal basis difficulties (III)

Well-established – Article 10a – Bibliographic applications • Data requirements as for a full original dossier - problem with relevance of the references • Bridging the product to the evidence from literature Often used where abridged applications can be more suitable.

The Organisation for Professionals in Regulatory Affairs

7

Differences in EU

Centralised procedure

Decentralised procedure

• Scientific advice

• Scientific Advice

• Pre-submission meeting

• Assessment of Draft responses during clock-stop • Break out session in the second phase

• Clarification TC after every LoQ

• Oral explanation – before opinion, if there are queries

The Organisation for Professionals in Regulatory Affairs

8