CRED Understanding Clinical Development 2024

08/10/2024

Scope of EU Paediatric Regulation

Mandatory

• Drugs for which the company does not already hold an MA

Article 7

Optional

Off-patent drugs

Article 30

• Authorised drugs still under patent protection if you want

Article 8

• New indication (including paediatric) • New pharmaceutical form • New route of administration

Results in a PUMA

There are automatic exemptions for generics, biosimilars, herbals and homeopathics

Exemptions are tied to the legal basis for MAA

The Organisation for Professionals in Regulatory Affairs

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What is a PIP?

• R&D programme investigating possible value to the paediatric population…

• …which specifies what is to be studied, how and when

• Expected to be submitted before Phase II development in adults

• Reviewed and approved by EMA’s Paediatric Committee (PDCO)

• Waivers are available if paediatric development is not appropriate

Deferrals can be requested

•

• Waivers and deferrals must be very carefully justified

The Organisation for Professionals in Regulatory Affairs

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