European Medicines Agency regulatory support services

Provided by European Medicines Agency

EMA provides regulatory and scientific support to foster development of new and innovative medicines, from the early phases in the laboratory all the way to the patient.

EMA achieves it through the following resources:

Innovation Task Force (https://www.ema.europa.eu/en/human-regulatory/research-development/innovation-medicines#ema’s-innovation-task-force-(itf)-section)
EU Innovation Network (https://www.ema.europa.eu/en/human-regulatory/research-development/innovation-medicines#eu-innovation-network-section) /
SME Office (https://www.ema.europa.eu/en/human-regulatory/overview/supporting-smes)
PRIME scheme (https://www.ema.europa.eu/en/human-regulatory/research-development/prime-priority-medicines)
Qualification advice on novel methodologies (https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-advice-protocol-assistance/novel-methodologies-biomarkers/opinions-letters-support-qualification-novel-methodologies-medicine-development)
Scientific advice / protocol assistance (https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-advice-protocol-assistance)
Post-authorisation (https://www.ema.europa.eu/en/veterinary-regulatory/post-authorisation)
Pilot for Simultaneous National Scientific Advice (SNSA): : in one single step national scientific and/or regulatory advice can be requested with two NCAs simultaneously. The focus of the SNSA is on innovative developments to identify the needs of the applicants to enhance innovation and avoid gaps in early regulatory support. The pilot aims at exploring the opportunities and interest in providing such coordinated national scientific advice particularly to developers of new medicines and therapies (https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-applicants-pilot-simultaneous-national-scientific-advice-snsa_en.pdf)

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