MHRA completed consultation on real-world evidence in December 2020

  • Guidance issued for Sponsors planning to conduct clinical research to support regulatory decisions
  • Use of RWE has the potential for increasing the speed and reducing the cost of development programmes, which would see effective medications being approved more quickly
  • The MHRA encourages Sponsors to explore the opportunities presented by the utilisation of RWE
  • RWE just as valuable for regulatory decision making as evidence from conventional RCTs, provided the data quality is robust and the trial well designed

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About SVMPharma

SVMPharma is an innovative strategic consultancy, specialising in Real-World Evidence (RWE) for the pharmaceutical industry. SVMPharma generates RWE within UK and Europe through bespoke online Real-World Treatment Evaluators, leading to successful health technology appraisal (HTA) submissions. Clinical trial programmes do not reflect real-world clinical practice and outcomes, RWE supplements and enhances clinical datasets. SVMPharma’s specialist teams focus on delivering the outcomes that matter to your brand.

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