What EMA PRIME Scheme - Priority Medicines (PRIority MEdicines): Early Dialogue for Unmet Medical Need Products, Dedicated Point of Contact, Free Scientific Advice, Proactive Support during Development, CHMP Appointment of Rapporteur and Rolling Review Option requires
The EMA PRIME scheme provides enhanced regulatory support to developers of medicines targeting unmet medical needs in the EU, based on preliminary clinical or non-clinical evidence of significant therapeutic potential. It applies to sponsors in the exploratory clinical trial phase seeking early scientific advice, rapporteur appointment, and potential eligibility for accelerated assessment under Regulation (EC) No 726/2004.
Pillar: Pharmaceuticals & Life Sciences · Authority: European Medicines Agency (EMA) · Version: 1.0.1 · Last updated:
Primary source: https://www.ema.europa.eu/en/human-regulatory-overview/research-development/prime-priority-medicines
SHA-256 integrity: d2f2e8fe150779b40cbf2bfe6f1911fdcd21a9a9e8f732e8fa3fd23f240486ad
Primary Citations — 5 traced to source
- PRIME: priority medicines, https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/prime-priority-medicines, Eligibility criteria, 2024
- European Medicines Agency Guidance for applicants seeking access to PRIME scheme, https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ema-guidance-applicants-seeking-access-prime-scheme_en.pdf, Reference Number: EMA/7872/2021, 2024
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