Module232025

07/05/2025

Material changes proposed in revised legislation

• Article 75: Waiver grounds

Impact

Current

You could be required to develop in a paediatric indication even if the targeted adult condition does not occur in children

Most likely to impact in oncology

Proposed

The Organisation for Professionals in Regulatory Affairs

49

Material changes proposed in revised legislation

• Article 76: Timing of PIP submission

Different language intended to mean the same thing Impact Helpful clarification but not game-changing

Current

Proposed

The Organisation for Professionals in Regulatory Affairs

50