CRED ERP 25

01/07/2025

National Scientific Advice MEB (5/5)

MEB’s scientific advice procedures:

➢ Scientific advice can never be a substitute for an application for marketing authorisation and the advice provided has no bearing on the final assessment of the MEB and/or the CHMP. The MEB will not carry out a (preliminary) assessment of results or data outside the context of the dossier as a whole or attach any conclusion to it. The MEB will not make a decision on the benefit-risk balance! ➢ MEB is also participating in pilot for Simultaneous National Scientific Advice (SNSA) For more information/applicationform/fees: See MEB website: https://english.cbg-meb.nl/topics/mah-scientific-and-regulatory-advice

The Organisation for Professionals in Regulatory Affairs

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Maximise effectiveness of advice

Formulating questions

• Is the answer already available in guidance? Do you want to deviate?

• Briefing documents: be concise

– Not too little – to allow informed decisions

– Not too much – to allow proper review

No pre-evaluation

•

✓ If we perform this set of (non)clinical studies, would that be sufficient to start a phase III clinical study?

X We have performed the following (non)clinical studies, are the results a sufficient justification for starting a phase III study with a dose of X mg/kg?

The Organisation for Professionals in Regulatory Affairs

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