MHRA’s New International Recognition Procedure

Landkarte *** Europa | Image Credit: © beugdesign - Stock.adobe.com

On 1 Jan 2024, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) launched its new International Recognition Procedure (IRP) (1). This new procedure replaces the European Commission’s Decision Reliance Procedure (ECDRP) and will allow MHRA to conduct a targeted assessment of IRP applications but also retain the authority to reject applications if the evidence provided is considered insufficiently robust. The Decentralised and Mutual Recognition Reliance Procedure (MRDCRP), which allows MHRA to approve products in the European Union, will be incorporated under the umbrella of the IRP (2). Therefore, any ECDRP and MRDCRP applications for marketing approval received by MHRA after 1 Jan. 2024 will be assessed under the new IRP (2).

New IRP to fast-track medicines

The industry will be able to rely on the IRP for fast-track marketing authorization (MA) in the UK if the products have already been approved by trusted medicines regulators in Australia, Canada, Japan, Switzerland, Singapore, and the United States, or, in the EU, where products have obtained a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) based on the ECDRP (3).

The IRP will assess marketing authorization applications (MAAs) based on the Human Medicines Regulations 2012 (HMRs) for the following:

• biosimilar applications (Regulation 53, 53A, and 53B)
• chemical and biological new active substances and known active substances (Regulation 50)
• generic applications (Regulation 51, 51A, and 51B)
• hybrid applications (Regulation 52, 52A, and 52B)
• new fixed-combination product applications (Regulation 55) (1).

The IRP can also be used for post-authorization procedures including line extensions, variations, and renewals but not for the review of Traditional Herbal Registrations, Homoeopathic Registrations (Simplified Registration Scheme), and Homeopathic National Rules Authorisations (National Rules Scheme).

MHRA retains the ultimate authority to accept or reject applications submitted under the IRP. Until parts of the Windsor Framework related to medicines come into force in January 2025, products falling within the scope of the EU centralized procedure can only be authorized in Great Britain, which excludes Northern Ireland (1).

Two routes for MAAs

The IRP includes two routes for MAAs, Recognition A and B, which reduce the review authorization period from the current turnaround of 150 days to 60 or 110 days, respectively (Table I). To benefit from the Recognition A route, the same manufacturing process must apply to the product as that considered by the reference regulator (RR) (3).

Table I. Summary of Recognition A and B procedures. Where ATMP stands for Advanced therapy medicinal product; CHM for Commission on Human Medicines; MA for Marketing Authorisation; and RR for reference regulator.

In 2023, MHRA launched an Eligibility Checker tool to help drugmakers consider the new pathway (4). All applicants are required to submit their MAA six weeks before the planned submission date (5).

According to the Association of British Pharmaceutical Industry (ABPI) “the IRP is an additional flexibility for medicine developers, which may offer some added value for products approved in other jurisdictions” (5). Although the majority of products are likely to fall into Recognition B, which cuts current review time by 40 days, both pathways should lead the way for faster product approvals and patient access to innovative medicines.

ABPI required further clarification

In the meantime, the ABPI is asking for clearer guidance on MHRA’s regulatory flexibilities and the impact of the IRP, on market and patient access, the Innovative Licensing and Access Pathway (ILAP), and the Early Access to Medicines Scheme (EAMS), citing clinical trials in the UK and seeking scientific advice (6,7). Future clarification of this regulation will enable the industry to optimize its drug development programmes and ensure they select the right procedure at the right time for the right product. Companies will need to consider which products fall under which route to maximize the new fast‑track system.

The new IRP should enhance the attractiveness of launching products in the UK

According to Natalie Coan of Pinsent Masons, a specialist in life sciences regulation, “the IRP should enhance the attractiveness of the UK as a market for new medicines…” (3). The new IRP should help to streamline the pathway for pharmaceutical companies and encourage them to launch products earlier in the UK following approval overseas.

References

1. MHRA. International Recognition Procedure. GOV.UK, 5 Jan. 2024.
2. Nauth, L.; Worden, T. UK’s Medicines Regulator Announces Guidance on the New International Recognition Procedure for the Approval of New Medicines from 1 January 2024. Godwin Blog, 15 Sep. 2023.
3. Coan, N. UK International Recognition Procedure Promotes Faster Access to New Medicines. Pinsent Masons, Out-Law Analysis, 20 Oct. 2023.
4. MHRA. International Recognition Procedure Eligibility Checker. GOV.UK, Accessed 16 Jan. 2024.
5. O’Connor, D. MHRA’s New International Recognition Procedure (IRP): How Does it Shape Up? ABPI.org.uk, Blog Post. 12 Sep. 2023.
6. MHRA. Innovative Licensing and Access Pathway. GOV.UK, published 30 Mar. 2021, last updated 27 Jan. 2023.
7. MHRA. Apply for the Early Access to Medicines Scheme (EAMS). GOV.UK, published 18 Dec. 2014, last updated 18 April 2023.

About the author

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

Article details

Pharmaceutical Technology Europe
Vol. 36, No. 2
February 2024
Pages: 7–8

Citation

When referring to this article, please cite it as Barton, C. MHRA’s New International Recognition Procedure. Pharmaceutical Technology Europe, 2024, 36 (2), 7–8.