CRED Understanding Clinical Development 2024

08/10/2024

The EU Paediatric Regulation

Regulation (EC) No 1901/2006

“The Paediatric Regulation”

https://www.ema.europa.eu/en/human-regulatory/research-development/paediatric-medicines/paediatric-investigation-plans

The Organisation for Professionals in Regulatory Affairs

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Requirements and incentives

Incentives

Requirements

!

• Free scientific advice relating to paediatric development

An MAA cannot be validated unless:

• A PIP (or waiver) has been agreed with EMA

• 6-month extension to supplementary protection certificate (for adults and children) where MA is present in all EU countries

• Compliance with the agreed PIP has been confirmed

OR

• Market exclusivity for orphan drugs extended from 10 to 12 years

The Organisation for Professionals in Regulatory Affairs

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