What EU Paediatric Regulation 1901/2006 - Paediatric Investigation Plan and Waiver Requirements requires
Regulation (EC) No 1901/2006 requires all applications for new marketing authorisations (MAs) and extensions of indication to include a Paediatric Investigation Plan (PIP) agreed with EMA's Paediatric Committee (PDCO), or an agreed waiver/deferral. PIPs must be submitted early in development and agreed before completion of Phase 2 adult trials. Compliance is rewarded with a 6-month patent/SPC extension (10 years market exclusivity for orphan medicines). Non-compliance prevents MA approval.
Pillar: Pharmaceuticals & Life Sciences · Authority: European Medicines Agency (EMA) · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32006R1901
SHA-256 integrity: c7638e2d54cba8a382772844940f7944c2372dcb652baf7c5a39bed4c8dd1967
Primary Citations — 5 traced to source
- Article 15 (PIP submission), Article 36 (SPC extension), Article 11 (PDCO opinion) — Regulation (EC) No 1901/2006 on medicinal products for paediatric use
- PIP application and PDCO opinion procedure — EMA Paediatric Medicines - PIP submission guidance
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