CRED Successful and Skilful Communications 2025

Limitations to national scientific advice

• Restricted 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) • Prior agency advice is not legally binding for future marketing authorisation applications • Advice does not address ethical questions, e.g. whether a trial is acceptable in view of patients’ rights and safety • Different national regulators can give different advice, but joint advice with another regulator is possible • Mentioned in the EPAR

The Organisation for Professionals in Regulatory Affairs

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Respect cultural differences but not stereotypes

The Organisation for Professionals in Regulatory Affairs

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