Spring Intro 2023

30/03/2023

Tips and Challenges 4

Final Written Advice • EMA/CHMP Advice arrives about 3 weeks after meeting • Can be lengthy/extensive document • Review very carefully, clarifications may be required • Issue summary and full advice to wider Team as soon as possible (within 2 hours) • Only some national agencies provide (e.g. MHRA)

The Organisation for Professionals in Regulatory Affairs

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Regulatory Advice

What? • A formal process to obtain regulatory authority input on a drug development program Why? • Help companies answer important scientific questions related to drug development (most likely in the absence of formal guidance or where the company intends to deviate from guidance) • Complying with EMA scientific advice is associated with positive MAA outcomes When? • Any time but in particular a focus on key development milestones • Top tip: Ensure EU advice is discussed early enough to ensure availability around similar time as US advice How + Where? • Defined national and pan-EU regulatory procedures • Top tip: Quality of advice will depend on the expertise at the agency, so select national agencies carefully Who? • Extensive internal cross functional teams and EU regulators

The Organisation for Professionals in Regulatory Affairs

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