Regulatory Shortages and Delays - Navigating the MHRA's Post-Brexit Transition

This article explores key takeaways from a recent session at the 2023 PING Conference, where Dr Shirley Hopper (Deputy Director, Innovative Medicines, HQA at the MHRA) and Dianne Lee (Chair, Hertfordshire LEP Life Sciences Industry Panel; and CEO, DLRC) discussed these challenges and highlighted the MHRA's efforts in addressing them, as well as the actions industry players could take to facilitate this endeavour. The session also touched upon the role of artificial intelligence (AI) and the international recognition framework in improving efficiency and global harmonisation.

Tackling the Delays

Dr Hopper emphasised the MHRA's dedication to improving patient health and access to effective medicines despite post-Brexit challenges. The discussion revealed important insights into the regulatory delays.

To address delays in licensing products, the MHRA is actively boosting recruitment and training of assessors while enhancing the capabilities and expertise of existing staff. These measures aim to clear the backlog, particularly in the area of population health, where most of the backlog currently sits.

In addition, the MHRA has begun to prioritise clearing the backlog, rather than reviewing applications on a first-come, first-served basis. The agency is also working on providing greater predictability by publishing performance data on different application types.

The MHRA is continuing to prioritise applications based on public health needs and supply issues. During the pandemic, expedited procedures were implemented, prioritising new active substances, first generics, and first biosimilars to support the NHS. Timelines for established medicines are expected to return to normality by 2024, with clinical trials potentially resolving even earlier.

AI Opportunities

Recognising the need for increased efficiency, the MHRA appointed a Head of AI. AI is being explored for its potential in expediting the assessment process, which can be time-consuming due to lengthy dossiers. While AI will assist assessors in processing information more efficiently, it will not replace human decision-making. Exciting conversations are also taking place about utilising AI as a medical device, which could revolutionise the industry.

International co-operation

The MHRA is also actively developing an international recognition framework to acknowledge regulatory decisions beyond EU member states. This framework aims to include countries such as the US, Canada, Switzerland, Singapore, Japan and Australia and the initial rollout is scheduled for early 2024. By recognising foreign decisions, the MHRA can avoid duplication of efforts and target assessments more effectively. The agency is engaging with international partners to promote mutual recognition and harmonisation of regulatory frameworks and guidelines worldwide.

Our View

The challenges faced by the MHRA in navigating post-Brexit regulatory shortages and delays are having a significant impact on industry players, but the agency is taking steps to address them. Efforts to boost recruitment, enhance expertise, and prioritise applications based on public health needs demonstrate a commitment to ensuring patient safety and access to medicines. The integration of AI in the assessment process holds promise for increased efficiency, while the international recognition framework showcases a proactive approach towards global harmonisation.

But these steps alone are not enough. Close collaboration between the MHRA and industry stakeholders is going to be a crucial part of tackling these challenges, and Dr Hopper was really positive about close communication with industry at the PING Conference. Timely and transparent communication, sharing best practices, and leveraging international partnerships can help navigate these challenges more effectively. The industry must actively engage with the MHRA, providing valuable insights and support in streamlining processes to ensure the timely availability of safe and effective medical products in the UK market. Businesses must also be careful to ensure their applications are accurately completed to avoid being challenged or rejected.

While regulatory shortages and delays pose challenges for the MHRA, the agency remains committed to overcoming them and taking a pragmatic approach where required. Through strategic measures, AI integration, and the international recognition framework, the MHRA aims to streamline processes, enhance efficiency, and achieve global harmonisation. Active industry engagement during this transition period, combined with collaboration with the MHRA, is key to driving positive change in the regulatory landscape. Industry can play its part in helping the MHRA through this period.

For a further write-up, please see this excellent piece on the MHRA session at the PING Conference from Anna Smith of Eversana / Navlin Daily.

How are you finding engaging with the MHRA?  We would love to hear from you and your thoughts on this article. You can contact Alice Mennell in our Pharmaceuticals and Life Sciences team on 020 7665 0914, or complete the form below.