Module232025

12/05/2025

UK-PIP

• The MHRA is taking decisions on PIP and waiver opinions, modifications and compliance statements to support paediatric market authorisation decisions • Applicants should include information relevant to the UK, particularly with respect to any areas of unmet therapeutic need that their product intends to cover. • Parallel submission of PIPs to EMA and MHRA is strongly supported to allow robust parallel assessment and finally alignment of the agreed paediatric plans across jurisdictions. Submission of other relevant information, eg PSP if available. • The PIP application process for applicants is simplified by offering an expedited assessment where possible, and by mirroring the submission format, content and terminology of the EU-PIP system.

The Organisation for Professionals in Regulatory Affairs

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Regulatory Framework UK – Support by MHRA

• PIP related Advice and Meetings

Scientific Advice Meetings

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Clinical Trial Meetings

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ILAP-TPD meetings

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Contact the paediatric unit

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The Organisation for Professionals in Regulatory Affairs

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