The MHRA has launched a Real-Word Evidence programme to ensure that innovators understand how to use RWE to prove that medical products are safe and effective in line with regulatory expectations.

The pilot phase of this programme will give selected companies access to a confidential meeting with the MHRA to discuss RWE issues relevant to product development. Companies will also gain access to a “safe harbour” workshop run jointly by the MHRA and NICE on RWE. This pilot phase will run in 2025 and will not require the payment of fees to MHRA.

RWE provides information about real-world uses of medicines and medical devices. Its use is becoming more prevalent alongside, or in place of, randomized clinical trials for certain medical products. 

The MHRA has launched its Real-World Evidence Scientific Dialogue Programme as part of its Data Strategy, which sets out the regulator’s vision for how data and digital technology will deliver improvements and drive innovation in healthcare. 

The RWE programme is linked to MHRA’s objectives under Theme 1 of its Data Strategy – to support data-driven innovation, early access and interdisciplinary data science to underpin its regulatory framework. Clarity about the use of RWE was a central part of this theme, as MHRA has recognised that RWE will be key to developing many future products.

MHRA has four aims for the programme:

  • To clarify the expectations for RWE generation by setting out core principles and producing use cases 
  • To allow for open discussions between applicants and the MHRA
  • To increase clarity of regulatory and HTA expectations for data sources, data sets, analytical methodologies, and endpoints used to generate RWE
  • To produce reflection papers developed between MHRA, NICE and applicants 

Applications to the programme from a broad range of product types are welcome, including chemical drugs, biologicals and advanced therapies, with priority being given to applicants with a focus on:

  • Addressing pressing public health challenges, aligning with broader Government policy
  • Areas of significant unmet clinical need
  • Preventative medicine, interpreted broadly
  • Genomic data, biomarkers, or precision medicine approaches
  • Innovative methodologies or study designs that advance the field (e.g., improving representativeness in clinical studies, measuring effectiveness through RWD, etc.)

Applications will close on 4 April 2025.

If you have any questions about the regulation of medical products or market access, please contact our Healthcare team. This article was written by Rory Trust and Charlotte Colvin.