MHRA Publishes New Guidance on International Regulatory Recognition Route

On 4 Sep. 2023, the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) issued detailed guidance on the new International Recognition Procedure (IRP) for medicines manufacturers, including how to apply for a medicine licence (1). On 26 May 2023, MHRA announced new recognition routes would replace the current European Commission Decision Reliance Procedure (ECDRP) on 1 Jan. 2024 (2). The new process aims to bring cutting‑edge medicines faster to UK patients by leveraging the expertise and decision-making of trusted regulators in Australia, Canada, the European Union (EU), Japan, Switzerland, Singapore, and the United States (US) and enables MHRA to maintain its position as a sovereign regulator.

EU ‘reliance’ route to cease by the end of 2023

MHRA had previously introduced a temporary route to market for European-approved products in the UK, known as EU ‘reliance’ routes, to ensure that patients could continue to have timely access to new treatments. Currently, Regulation 58(4C) of the Human Medicines Regulations 2012 grants the power to MHRA to rely on the decision of the EC to approve a medicine in the UK for the MHRA to authorize that medicine in the UK without any further consideration, through a procedure known as the ECDRP. The EU ‘reliance’ route will cease on 31 Dec. 2023 and be replaced by the IRP following the completion of the MHRA public consultation, which is due to close on 30 Sep. 2023 (3).

The ECDRP is one of four routes

The ECDRP provided market stability following the UK’s exit from the EU, but now the MHRA is in a position to implement a more considered approach to the assessments and accept applications from a wider range of partners. It is important to note that the ECDRP is one of four routes for products that use the EU reliance procedure. The MHRA continues to operate the remaining routes beyond the termination of the ECDRP. These include:

• The ACCESS Consortium. This consortium is a collaboration of regulatory authorities including Australia, Canada, Singapore, and Switzerland. The UK joined the group in October 2020. The ACCESS consortium is based on a true work-sharing principle, to maximize international co-operation between partners, reduce duplication, and increase each agency’s capacity to ensure patients have timely access to high-quality, safe, and effective therapeutic products.

• Project Orbis. This project provides a framework for concurrent reviews of oncology products among international partners. Project Orbis aims to deliver faster patient access to innovative cancer treatments that cater to an unmet medical need and demonstrate notable results (3).
• The Mutual Recognition Decentralised Reliance Procedure (MRDCDRP). This procedure allows MHRA to take into account marketing authorizations (MAs) approved in EU member states (or Iceland, Liechtenstein, Norway) through decentralized and mutual recognition procedures to grant a MA in the UK (3).

New IRP pathway

The new IRP framework will be launched on 1 Jan. 2024 meaning all applications with a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), received after 31 Dec. 2023, will be eligible (4). According to David Watson, executive director of Patient Access at the Association of the British Pharmaceutical Industry, “The MHRA’s pragmatic decision regarding GB marketing authorization applications is an important one for our industry. Pharmaceutical companies now have the clarity needed to inform their regulatory decisions for the year” (4).

The new IRP established two recognition timetables for initial MA applications:

• Under “Recognition A”—a 60-day timetable will apply to approvals from other regulators granted within the previous two years provided the manufacturing process is the same as that already approved by the other regulator.
• Under “Recognition B”—a 110-day timetable will apply to approvals granted within the previous 10 years and will be triggered if any one of a range of criteria is met (5).

MHRA has streamlined clinical trial approval

Earlier in the year, MHRA announced it would be combining regulatory and ethics reviews for trials to speed up approval times and make the UK more attractive for drug research (6). Results from pilot studies indicated that approval times for studies could be halved and the time cut from application to recruiting of the first patient by up to 40 days. MHRA also plans to introduce a 30-day deadline for reviewing clinical trial applications plus a maximum of 10 calendar days for a regulatory decision to be granted once the agency has received any final information (6).

Future implications

MHRA’s decision to upgrade and streamline the regulatory review framework should help to speed up diagnosis and increase patient access to treatments whilst helping to propel the UK forward as a global leader in the life-science sector. In addition, the UK government’s proposal to set aside £10 million in funding to help accelerate the delivery of cutting-edge treatments, including cancer vaccines, should make it more attractive for scientists and researchers to work in the UK (6). On 11 Sep. 2023, it was announced that UK researchers and small to medium enterprises will be rejoining the Horizon Europe and Copernicus programme highlighting the important role that the UK hopes to play in the advancement of science now and in the future (7).

References

1. MHRA. Guidance Published on the New International Regulatory Recognition Routes for Medicines Approvals. GOV.uk, News Story, 4 Sep. 2023.
2. MHRA. MHRA Announces New Recognition Routes To Facilitate Safe Access To New Medicines With Seven International Partners. GOV.uk, News Story, 26 May 2023.
3. MHRA. Consultation on End to the European Commission Decision Reliance Procedure. GOV.uk, Open Consultation, 30 Aug. 2023.
4. ABPI. ABPI Response to MHRA European Commission Decision Reliance Procedure (ECDRP) Announcement. Press Release, 24 Jan. 2023.
5. Fischer, N. MHRA Issues Guidance on New International Recognition Procedure (IRP) for Streamlining Medicine Approvals in the UK. Marks&Clerk, Article, 5 Sep. 2023.
6. MHRA. MHRA to Streamline Clinical Trial Approvals in the Biggest Overhaul of Trial Regulation in 20 Years. GOV.uk, Press Release, 21 Mar. 2023.
7. UK Government. UK Joins Horizon Europe Under a New Bespoke Deal. GOV.uk, Press Release, 7 Sep. 2023.

About the author

Cheryl Barton is director at PharmaVision, Pharmavision.co.uk.

Article details

Pharmaceutical Technology Europe
Vol. 35, No. 10
October 2023
Pages: 8–9

Citation

When referring to this article, please cite it as Barton, C. MHRA Publishes New Guidance on International Regulatory Recognition Route. Pharmaceutical Technology Europe, 2023, 35 (10), 8–9.