Module232025

07/05/2025

Material changes proposed in revised legislation

• Major revision of EMA committee structure

• CHMP, PRAC • Retained as the two main EMA committees

• CAT, COMP, PDCO, HMPC • Expertise to be retained…

• …but reorganised as working parties and pool of experts supporting CHMP and PRAC (and CMDh which is not an EMA committee)

Potentially a very significant change

The Organisation for Professionals in Regulatory Affairs

47

Material changes proposed in revised legislation

• Article 74 • Provides for an “initial PIP” (iPIP) where: • Active substance is novel • Intention is to treat a novel paediatric indication • Full details and timings only required for measures known at time of PIP submission • Precise timing of future iPIP updates and final PIP delivery required • Qualification for iPIP must be requested and justified

Seems to be based on the “stepwise PIP” pilot principles An outbreak of common sense…?

The Organisation for Professionals in Regulatory Affairs

48