New UK MHRA International Recognition Procedure set to streamline medicines applications post-Brexit
UK MHRA’s International Recognition Procedure (IRP) launch marks a key post-Brexit Health Technology Assessment (HTA) milestone, in an effort to speed up patient access to new medicines in the UK
New UK MHRA International Recognition Procedure set to streamline medicines applications post-Brexit
Article written by Pamela Fetzer, Windrose Consulting Group
On January 2nd 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) launched their new “International Recognition Procedure” (IRP) in an effort to streamline the approval of new medicines and expedite access to new drugs for patients. This IRP framework is set to replace the European Commission’s Decision Reliance Procedure (ECDRP) and allows the MHRA to consider the expertise of specific Reference Regulators (RR) in other countries when evaluating applications for medicines already authorized elsewhere. Referenceable regulatory authorities include the Australian Therapeutic Goods Administration, Health Canada, Swiss Medic, Health Science Authority Singapore, the Japan Pharmaceuticals and Medical Devices Agency, the FDA, and the EMA. With each IRP application, the manufacturer is required to submit a set of documents specific to each RR (1).
Despite the input of these RRs, the MHRA maintains ultimate authority over applications submitted under the IRP, and offers two routes, A and B (1).
For Route A: the submitted product must have received approval from the relevant RR within the previous two years. However, it excludes products that meet any of the route B criteria (including most novel technologies such as first-in-class substances, single-arm studies, orphan drugs, or plasma products), which in any case will need to follow route B. After the submission is validated by the MHRA, the authorization will be reviewed within 60 days, unless major objections lead to revert to Route B.
For Route B: requires the submitted product to have received approval by the relevant RR within the past 10 years. It follows a 110-day period from validation, with a potential stop on day 70 if any issues with the application are identified. In the event of any further objections on day 110, a reversion to the national 210-day timetable (i.e., the standard timeline for authorizations of new medicines not already approved by RR) will occur, and the Commission on Human Medicines (CHM) will take over the decision. This route will be compulsory for most novel technologies, first-in-class substances, single-arm studies, orphan drug designations, real-world data, foreign-sourced competitors, and manufacturing changes.
While the EU continues to further centralize HTA regulations with the development of a European Joint Clinical Assessment (JCA), the implementation of this IRP framework marks another move to reduce dependence on EU HTA outcomes post-Brexit. According to the UK’s Health Minister Andrew Stephenson, this launch positions the country at the forefront of medical innovation, offering benefits not only to patients, but also to global regulatory partners and pharmaceutical companies developing innovative treatments (2). Notably, the timelines under the two different IRP routes are shorter than the MHRA’s original 150-day timeline to assess applications for new medicines already approved by EMA.
As outlined above, most innovative products will fall under the 110-day route B of this IRP. This process allows for reviews to be paused, suggesting that it may not be as competitive or favorable as the 150-day ECDRP route that it is replacing (2). However, based on available regulatory timelines and agnostic of manufacturer launch sequencing, this new reform means that the MHRA may have the option to approve products earlier than the EMA (which typically requires around a year from submission) when leveraging other regulatory agency approvals (e.g., FDA, which typically is the first regulatory approval) (3,4).
Overall, this IRP reform aims to provide manufacturers with greater flexibility regarding their launch timing in the UK, breaking the link to EMA approval. Nevertheless, the potential for delays following Route B poses a risk of uncertainty in the UK price submission. This aspect is crucial for international price referencing, considering that manufacturers can freely set list prices in the UK.
New UK MHRA International Recognition Procedure set to streamline medicines applications post-Brexit
Article written by Pamela Fetzer, Windrose Consulting Group