ARTICLE SUMMARY:
MHRA gets money to streamline regulatory pathways; announces plans to speed clinical trials. Excerpted from Pathways' Picks March 22: Post-COVID Guides are Coming, VR Code is Here.
In a rare explicit mention of medical devices in a UK budget, the country’s HM Treasury department designated £10 million to the Medicines and Healthcare products Regulation Agency (MHRA) to establish accelerated regulatory routes for devices and drugs, including one to speed the path to market for UK-developed technologies and a separate “mutual recognition” path to expedite access to products already approved by trusted international partners. In the Spring Budget documents posted March 15, MHRA is directed to first establish recognition routes for US FDA- and Japan PMDA-approved products. The UK 2023 budget also targeted broader support for more flexible regulation of digital technologies, including AI tools. The budget highlights plans for an upcoming white paper to address new approaches for regulating AI and the near-term launch of an “AI sandbox” to “test how regulation could be applied to the future of AI, while supporting innovators in getting their cutting-edge products to market without being blocked by the usual rules.”
MHRA on March 21 affirmed its plans to overhaul clinical trial regulations to make it faster and easier to perform trials in the UK, following a consultation on the reforms last year. The overall goal is to make the clinical trials application process more “proportionate, streamlined and flexible,” MHRA says. Specific elements of the planned reforms including integrating regulatory and ethics reviews for trials and setting specific decision timelines. The changes will require legislative approval and will be accompanied by guidance on “how to include patients meaningfully into the design and conduct of trials, and how to achieve diversity in trials in a way that is proportionate and achieves the best results,” MHRA said.
MHRA published a new guidance March 22 on how to properly craft an intended purpose statement for a software as a medical device (SaMD) product to support safety and regulatory review. The guidance outlines the agency’s common concerns with intended purpose statements and best practices.
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