What Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 requires
This regulation mandates that pharmaceutical developers submit a Paediatric Investigation Plan (PIP) to the European Medicines Agency's Paediatric Committee (PDCO) before initiating clinical trials for new medicines…
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Pillar: Pharmaceuticals & Life Sciences · Authority: European Medicines Agency (EMA) · Version: 1.0.1 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32006R1901
SHA-256 integrity: f9862ef669c1e8e7cbc00a6d555ce6cd6d78de1feef2d89342c1af25cb8f98a6
Primary Citations — 5 traced to source
- Regulation (EC) No 1901/2006, Article 7 - Submission of Paediatric Investigation Plan (PIP)
- Regulation (EC) No 1901/2006, Article 8 - Opinion of the Paediatric Committee (PDCO)
+ 3 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
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- Discovery (free): /api/v1/nodes/eu-paediatric-regulation-1901-2006-pharma.json — 6-field metadata
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