CRED Understanding Clinical Development 2024

08/10/2024

Scientific advice

CHMP

National

Single opinion, may not reflect national differences May advise a cautious, low risk approach Likely to carry more weight at time of MAA

Can obtain a number of opinions

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May reflect differences between national views

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More potential for informal exploration

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The Organisation for Professionals in Regulatory Affairs

9

Simultaneous National SA

• Guidance for applicants on a pilot for Simultaneous National Scientific Advice (SNSA)

• Pilot started 1.2. 2020 – 11 NCAs involved

• Opportunity to reach alignment/clarification of NCAs on specific critical issues before an application

Can take more time?

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The Organisation for Professionals in Regulatory Affairs

10