CRED Successful and Skilful Communications 2025

For medicines, scientific advice in Europe is … • Prospective in nature • Not legally binding with regard to any future application of the product concerned • Limited to scientific issues - regulatory aspects (e.g. legal basis for submission, GCP/GLP/GMP related questions, format of application) should be the matter of a separate request (pre-submission meeting) • Mentioned in the EPAR • Possibly joint advice between • CHMP and FDA (in parallel) • HTA agencies and CHMP / or national regulators • Possible, if recommendations from the US and EU differ significantly

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The Organisation for Professionals in Regulatory Affairs

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• Companies ● e.g. Scientific Advice, follow-up advice, labelling, promotional material, procedural questions • National authorities or EU Committees ● e.g., oral explanations, safety referrals in PRAC-CHMP ● Note: procedural questions normally free, as would be when regulators summon hearings with companies. Normally when a company requires scientific advice a fee is involved Both sides can request interactions – formal and informal

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The Organisation for Professionals in Regulatory Affairs

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