Module232025

12/05/2025

Pediatric Review Committee (PeRC)

• Consultation to FDA’s Review Divisions ‘prior to approval’ • Pediatric Plans • Deferral and Waiver Requests • Assessments • Written Requests • Exclusivity Determinations • Divisions still have decision authority

The Organisation for Professionals in Regulatory Affairs

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Regulatory Framework - UK

• Regulation 50(A) to (E) of Human Medicines Regulations 2012, as amended by the

Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (HMRs)

Paediatric Investigation Plans

• Regulation 78A(13) and (14) of Human Medicines Regulations 2012, as inserted by the

Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (HMRs)

Completed Paediatric Studies

AIM Ensure that where appropriate, medicines are adequately studied in children and developed to meet their needs, including for age-appropriate formulations

The Organisation for Professionals in Regulatory Affairs

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