The UK MHRA’s Latest Update on the International Recognition Procedure
Introduction
The Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom has taken a significant step towards enhancing its regulatory processes. The reason behind this step is to facilitate medicine access by expediting their approval. The MHRA has recently released comprehensive guidance on the new International Recognition Procedure (IRP), which is set to take effect from January 1, 2024. The IRP will fast-track applications from specific countries and cover various authorization types. It incorporates Mutual Recognition and Decentralized Reliance for EU states, but the MHRA retains discretion in approvals.
Requirement for International Recognition Procedure
The introduction of the IRP is a direct response to the changing landscape of pharmaceutical regulation in the wake of the UK’s exit from the European Union (EU). Indeed, the UK MHRA recognized the necessity of streamlining and accelerating the authorization process for pharmaceuticals that have already been approved by trusted international regulatory bodies. This recognition paved the way for the IRP, which builds upon the temporary EC Decision Reliance Procedure (ECDRP), scheduled to conclude on December 31, 2023.
The IRP is poised to open doors for pharmaceutical companies in specific countries, allowing them to expedite their marketing authorization applications in the UK. The eligible countries include Australia, Canada, Japan, Switzerland, Singapore, the United States and the European Union.
Applicants that have received product approval from the regulatory bodies of the countries listed above are eligible for the IRP.
One of the remarkable aspects of the IRP is its incorporation of the Mutual Recognition and Decentralized Reliance Procedure (MRDCRP) for EU member states. This integration streamlines the process of bringing international medicines to UK patients, further enhancing the efficiency of the approval process.
MHRA's Discretion
It is important to note that the MHRA retains the discretion to approve or reject applications. This discretion ensures that regulatory standards and patient safety remain paramount in all authorization decisions. A separate UK MHRA authorization is still a prerequisite for marketing pharmaceutical products in the UK.
Recognition Timetables
The IRP introduces two recognition timetables, namely Recognition A and Recognition B. These timetables are designed to accommodate applications of varying complexities and ages of overseas regulatory approvals:
Recognition A: 60-day processing window for recent and straightforward applications. It is suitable for products with overseas regulatory approvals granted within the previous 2 years and without significant complex factors.
Recognition B: 110-day processing window, making it ideal for more complex cases. It applies to products with overseas regulatory approvals granted within the previous 10 years and may involve various complex factors.
The IRP is not limited to initial marketing authorization applications. It can also be utilized for post-authorization procedures, such as line extensions, variations, and renewal applications. While it is recommended to maintain consistency by using the same overseas regulator throughout a product’s lifecycle, there may be justifiable reasons to involve multiple regulators based on patient benefit grounds.
The timetables set by the MHRA for national post-authorisation procedures will apply to applications processed through the IRP. It’s essential to note that the MHRA reserves the right to reject a variation application if the evidence provided is deemed insufficient.
Further Details and Guidance
The comprehensive guidance provided by the MHRA covers a wide range of aspects related to the IRP, including detailed information on forms and document requirements, the application process, national requirements, and associated fees. This guidance serves as a vital resource for pharmaceutical companies seeking to navigate the new International Recognition Procedure effectively.
In summary, the MHRA’s International Recognition Procedure (IRP) represents a significant leap forward in the regulatory landscape, offering a streamlined and efficient pathway for pharmaceutical companies with overseas approvals to obtain marketing authorizations in the UK. This initiative aims to facilitate the entry of essential medicines into the UK market while upholding stringent regulatory standards and ensuring patient safety. Starting from January 1, 2024, the IRP promises to reshape the pharmaceutical regulatory environment in the UK, benefitting both the industry and patients.
References and Further Reading
- UK MHRA. International Recognition Procedure. Medicines and Healthcare products Regulatory Agency. 2023