MHRA Launches Real-World Evidence (RWE) Pilot Program in 2025

The UK Medicines and Healthcare products Regulatory Agency (MHRA) is launching a Real-World Evidence (RWE) Scientific Dialogue Programme in 2025 to promote data-driven innovation and early access to innovative products.

Key Details:

• Applications Open: February–April 2025
• Priority Selection: Projects aligning with government policy, clinical needs, and public health challenges
• Eligibility: Pre- and post-authorization evidence, safety and effectiveness claims, and innovative study designs
• Meeting Schedule:
  May 2025: Applicant selection notifications
  May & July 2025: Virtual meetings
  June 2025: Workshop

The program will support regulatory and HTA evaluations, guiding companies on RWE use throughout a product’s lifecycle.

Region: European Union

Source: https://www.gov.uk/government/publications/mhra-real-world-evidence-scientific-dialogue-programme/mhra-real-world-evidence-scientific-dialogue-programme