Optimising Timelines: How the MHRA are Enhancing Regulatory Procedures for Future Success

There are notable advancements in the MHRA’s efforts to address their backlog and enhance overall efficiency in application processes across the board. The introduction of proactive measures and new initiatives offers a glimpse into a future that is simpler and more streamlined in dealings with the MHRA. There are some key areas where developments can be seen progressing rapidly.

Established active substance applications.

  • In an attempt to further shorten assessment timelines through promotion of ‘right first time’ submissions, the MHRA has in the first instance created optional checklists for established active substance MAAs. These checklists are based on common pitfalls in regulatory submissions relating to proposed product information, and bioequivalence studies and proposed biowaivers, and are designed to empower applicants to submit accurate submissions from the outset.

Clinical trials

  • Performance data has been released for the assessment of clinical trials and established medicines, showing a significant improvement in the backlog of applications. The MHRA states “The backlog of 966 clinical trial applications from when we began our crisis response in mid-July has been eliminated. Applicants will have seen increased rates of assessment in all key areas, as we focused our resources within the agency to deliver accelerated improvements to timescales.”.
  • The MHRA has recently announced a new notification scheme for low-risk clinical trials, as part of their ongoing overhaul of clinical trial regulation. Under this new scheme the MHRA will “implement a timeline for completion of an application review within a maximum 30 days in general, with a maximum 10 calendar days for a decision to be granted once the regulator has received any final information”.

Regulatory pragmatism and streamlined processes

The MHRA continues to deliver new guidance on the upcoming IRP, due to come into force on 1st January 2024, recently providing a supplementary information document to sit alongside the main guidance, as well as delivering webinars to engage with industry on a smooth transition to the new process.

Medical Devices

  • A pilot has been launched for the Innovative Devices Access Pathway (IDAP) with the aim to “improve patient access to innovative and transformative medical devices by providing an integrated and enhanced regulatory and access pathway to developers”. This sits alongside the “AI-Airlock” for collaborative development of AI software and medical devices.
Lauren Foster
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