Module232025

07/05/2025

PIPs versus scientific advice

Scientific advice

MA

Non-clin

Post approval

1

Compliance

Amendments

Paed. Investig. Plan

The Organisation for Professionals in Regulatory Affairs

31

Scientific advice

• PIPs and scientific advices are handled by separate committees (PDCO and CHMP, respectively). • CHMP Scientific advice is FREE of charge for questions relating to the paediatric programme at any time during development. • A CHMP scientific advice with paediatrics-related questions will be viewed as important in the PIP assessment • Simultaneous procedures discouraged • EMA on when a procedure is applicable for a scientific advice and when it should rather be directly referred to a PIP procedure: • European Medicines Agency Guidance for Applicants seeking scientific advice and protocol assistance (europa.eu)

The Organisation for Professionals in Regulatory Affairs

32