pgsd, I agree that there are some politicians in the UK, that have been very interested in seeing rapid approvals for this and other innovative treatments. They talk a good game, but what have they done since the rapid Covid treatment approvals years ago? Government agencies are also bureaucratic and lack the ability or motivation to move quickly or implement changes. It finally took the public and industry to pressure these politicians to act this year and provide the proper funding to the MHRA to implement the changes that were necessary to get new medicines in the clinic and eventually to the public.
For years, the MHRA was in line with the EMA, which has a 210-day accelerated approval process, but some politicians in the UK wanted to show that the MHRA can “lead the world” in rapid approvals after Brexit, so they created the 150-day process (without the 60-day clock-off period). Unfortunately, they didn’t give the MHRA the proper resources or institute the necessary process changes to accomplish this, so it has been unable to meet that 150-day target, and approval timelines have actually been stretched beyond 300 days in many instances, due to staffing and other issues.
So at this point, now that the MHRA has finally hired new assessors and streamlined processes, and regulatory backlogs are being cleared, how fast can the MHRA actually review the application? Can they now assess a high priority application in 150 days total as they once touted? (which would be May)
The MHRA’s Deputy Director, Innovative Medicines, Dr. Shirly Hopper said that many would be happy if they could just meet the 210-day timeline again, which is why I think July seems reasonable, but I certainly leave open the possibility that the MHRA can pull a rabbit out of the hat for Northwest Bio, and approve it more rapidly.
MHRA Post-Brexit: Where Are We? 22 Jun 2023
NAVLIN Brief
As the MHRA strives to remain financially sustainable as a sovereign regulator, the underlying mission remains to improve patient health. But as a UK public sector body, the group is under pressure to optimize productivity and provide value for money, making the ongoing transformation more challenging to navigate
Throughout the pandemic, the MHRA chose to prioritize COVID-related products and divert resources, causing knock-on effects in assessments for other therapeutic areas. Ironing out Brexit changes compounded this and despite the post-Brexit European Commission Decision Reliance Procedure (ECDRP), which allowed the Agency to “rely” on a European decision to grant a new marketing authorization for a product, the MHRA has been weathering a period of uncertainty over the last two years.
Delays Speaking with Dianne Lee, Chair of Hertfordshire LEP Life Sciences Industry Panel and CEO, DLRC, Dr. Hopper explained that most of the licensing backlog sits within population health, “which comes down to prioritization.” To work through the backlog, the group is “recruiting and training new assessors, pharmaceutical assessors, and medical assessors.” She added, “We are also working really hard to improve expertise and expand capability. Also, expanding capacity with things like time recording exercises. We’ve been looking hard at assessment processes and streamlining the pharmaceutical module three part, bringing in other scientific assessors to do some of the less technical aspects of the assessment.”
AI Transformation The MHRA has been discussing the use of AI with international partners at a “very early stage,” according to Dr. Hopper. Primarily, the Agency has been looking at how AI could be involved in the assessment process of an individual product. Dossiers contain thousands of pages, so the relevant assessors “focus on key documents and dip into the supporting data when questions arise.” A “simple way” to use AI, Dr. Hopper believes, would be to use it to help answer those questions.
Prioritization Speaking at the PING conference, Dr. Hopper explained: “We’ve always prioritized to a certain extent, but the backlog means we have to really prioritize some applications instead of first come, first served. During the pandemic, COVID-19 products were given very high priority and those procedures were expedited, for example, with a rolling review.” The MHRA also prioritizes new active substances over generics, as it can potentially give a clinician a new tool to treat a patient. “We look at particular areas of unmet need and see whether the product could meet that area of unmet need. We also prioritize established medicine applications where there is a supply issue.”
The MHRA is “engaging much more with international partners.” Dr. Hopper notes, “We’re doing unilateral recognition, working toward mutual recognition. We want to increase the number of products that come through on work sharing. Project Orbis is another example. We want to be doing a lot more in that space and bringing about a lot more harmonization of the regulatory framework and guidelines across the world.”
The Future of the MHRA Overall, she sees the need for the organization to approach the transition with pragmatism. Having a “streamlined pathway” for applications already reviewed by a stringent regulator could help the MHRA regain predictability.
Dr Hopper believes the future is looking positive, partly because “now that face-to-face is back and colleagues are helping to work on guidelines coming through, morale is improving.”
Pre-Brexit, the MHRA endeavored to complete the assessment for a national marketing authorization (MA) application within 210 days, excluding procedural clock-stop. Post-Brexit, the group proposed a 150-day assessment timeline for all high-quality MA applications. Due to backlog and other procedural issues, the timeline is stretched; some applications are even taking up to 400 days to complete.
According to Dr. Hopper, “Even if it were back to 210 days, people would be happy. However, we want to return to 150 days, or even quicker for rapid assessments.”
