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: 86e09b0c39a19f339b7a0d6c72b0a59dfc21b7b067edb4585c4620214bb93bc1
Primary Citations — 5 traced to source
- {"title":"Regulation (EC) No 1901/2006 on medicinal products for paediatric use","url":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32006R1901","section":"Article 15 (PIP submission), Article 36 (SPC extension), Article 11 (PDCO opinion)"}
- {"title":"EMA Paediatric Medicines - PIP submission guidance","url":"https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/paediatric-medicines-overview","section":"PIP application and PDCO opinion procedure"}
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