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ViewAttendees 5

Pharmaceuticals

Domain: Regulatory Frameworks & Strategy

Knowledge Area: Market Strategy

EMA's PRIME Scheme in Review: Findings, Lessons Learnt and Future Directions

Friday, May 12, 2023
10:45 – 11:45 CEST
Location: Pearl 2

Supported By
Description: In 2016, the European Medicines Agency (EMA) launched PRIME (PRIority MEdicines), a scheme to enhance support for the development of medicines that target an unmet medical need. With PRIME, the EMA engages with medicine developers early to optimise development plans and speed up evaluation so these medicines can reach patients earlier. The objectives of PRIME are to Reinforce scientific and regulatory advice, to optimise development for robust data generation, and to promote accelerated assessment of the marketing authorisation application (MAA).

In this session, we will discuss the impact of PRIME on development and market authorisations of new medicines, assess the lessons learnt through first-hand experience of the scheme, as well as experience the EMA’s analysis of first 5 years of experience with the scheme. We will discuss the improvement and evolution of the scheme in 2023 and beyond, and how PRIME can continue to support global drug development and innovation for medicines targetting an unmet medical need


Learning Objectives:

  • Describe the objectives of PRIME and its impact of market authorisations of new medicines
  • Learn the updated PRIME features launched in March 2023 to improve the scheme
  • Understand the strengths of PRIME support from drug developers’ perspectives, and the areas for improvement and evolution