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Life Science is a global business, and patients across the world benefit from the ability of their national regulatory bodies to recognise the procedures for authorisation of new medicines implemented in other countries. In this article, we briefly discuss the regime for putting medicines on the market in the UK before considering the new International Recognition Procedure that came into effect on 1 January 2024 and key points for life sciences businesses to consider.
Licensing of medicinal products in the UK
A business that wants to place a new medicine on the UK market must obtain a licence (referred to as a marketing authorisation) from the Medicines and Healthcare Products Regulatory Agency (the MHRA), which is the UK government agency tasked with ensuring that medicines and healthcare products available in the UK are safe and effective.
The MHRA’s responsibilities extend to a range of other matters related to ensuring the integrity of the supply chain for licensed medicines, including conducting inspections to ensure that medicines are developed, manufactured, distributed and monitored to internationally recognised standards.
In issuing its marketing authorisation for a new medicine, the MHRA will publish a summary of product characteristics, which will outline, among other things, the indication(s), recommended dose(s), contraindications, and special warnings and precautions for use on which the marketing authorisation is based (i.e. the terms of the licence), to allow those responsible for prescribing medicines to understand when and how the medicine may be used.
For completeness, a limited set of exemptions to the requirement for marketing authorisation apply, but these are carefully restricted by law (and a business considering relying on any of the exemptions should do so with caution). Some defined categories of medicinal products can be distributed on an ‘unlicensed’ basis, including specified types of unlicensed herbal remedies and homoeopathic remedies.
In addition, medicinal products that do not fall within a category that is generally exempt from the licensing requirement may nevertheless be prescribed by a practitioner as ‘specials’ in a limited set of specified circumstances and supplied in response to such a prescription. Similarly, the ‘specials’ regime allows a licensed product to be prescribed for uses outside the terms of its licence, again in specified circumstances.
Obtaining marketing authorisation in the UK
A range of routes to achieving marketing authorisation in the UK have existed historically, and these have been subject to change since the UK’s departure from the EU.
While the UK remained a member of the EU, these routes included a centralised procedure, which allowed medicine to obtain a Community Marketing Authorisation (CMA) valid throughout the EU.
At the same time, the mutual recognition procedure allowed a medicinal product which had already received a marketing authorisation in one EU member state to be marketed in any other EU country (so long as it did not fall within the mandatory scope of the centralised procedure).
The decentralised procedure had a similar effect but applied in circumstances where the initial application for authorisation in the first EU country was still in progress at the point when the application for recognition in another member state commenced.
By way of reducing disruption in the period since the UK’s departure from the EU, the EC Decision Reliance Procedure (ECDRP) was implemented to allow the MHRA to continue to rely on EC approvals of medicines under the EU centralised procedure, and the Mutual Recognition/Decentralised Reliance Procedure (MRDCRP) was adopted to mirror the effect of the mutual recognition and decentralised procedures.
The International Recognition Procedure has now superseded the ECDRP and MRDCRP discussed below, which came into effect on 1 January 2024.
Other routes to obtaining marketing approval in the UK (not based on recognition of another country’s approval process) remain available, including:
- a 150-day assessment route (under which the MHRA undertakes to evaluate and reach an opinion on a proposed medicinal product within 150 days of a valid application being submitted),
- the Innovative Licensing and Access Pathway (designed to provide opportunities for eligible commercial and non-commercial developers of medicines to obtain enhanced regulatory and other stakeholder input during development), and
- a “rolling review” route of evaluation for novel products and biotechnological products.
The new International Recognition Procedure
Detailed guidance on the new International Recognition Procedure has been published by MHRA at International Recognition Procedure - GOV.UK (www.gov.uk) (the guidance), and this note summarises some key aspects of the procedure.
Like the ECDRP and MRDCRP routes, which it replaces, the new International Recognition Procedure allows the MHRA to approve medicinal products by recognising approvals from specified ‘Reference Regulators’. The seven initial Reference Regulators are those of Australia, Canada, the European Commission, Japan, Switzerland, Singapore and the USA.
The International Recognition Procedure provides a fast-track approval process for medicinal products that have been approved by one of the specified Reference Regulators. In order to qualify, the medicinal product for which UK approval is sought:
- must be classified as a medicinal product under the UK Human Medicines Regulations;
- must be the same as that which obtained the Reference Regulator approval, meaning it must have the same qualitative and quantitative composition (active substance(s) and excipients) and the same pharmaceutical form and be from applicants belonging to the same company or group of companies or which are ‘licensees’;
- the applicant must be established in the UK or the EU/EEA.
The MHRA retains the right to reject applications if the evidence provided is considered insufficiently robust, but where the relevant conditions are met, and the MHRA considers the evidence sufficiently robust, it will conduct a targeted assessment of the application in accordance with one of two ‘Recognition’ processes.
Which process applies depends on the characteristics of the medicinal product in question (as established using an eligibility form completed by the applicant six weeks before the planned submission). Further information on this and other formal requirements regarding application are available in the guidance.
The key difference between the two Recognition processes for initial marketing authority applications is that ‘Recognition A’ works to a 60-day timetable (measured from the point at which the MHRA has validated the submission), whereas ‘Recognition B’ works to a 110-day timetable.
While both, therefore, offer a faster process than the 150-day assessment route for medicinal products that have not had approval by a Reference Regulator, the faster ‘Recognition A’ process is only available for applications where:
- The reference Regulator approval was granted within the previous two years;
- The manufacturing process is the same as that approved by the Reference Regulator, with evidence of compliance with Good Manufacturing Practice at the time of the UK submission and
- The medicinal product/ application does not have any of the long lists of characteristics identified as requiring the ‘Recognition B’ process – these include (by way of a few noteworthy examples from the full list set out in the Guidance) applications where the Reference Regulator granted a ‘conditional’ or ‘exceptional circumstances’ approval, where the product contains a first-in-class new active substance or incorporates novel or cutting-edge technologies, or where the pivotal clinical data include real-world data.
Accordingly, life science businesses should be aware of the hurdles that must be cleared to access the 60-day timetable for Recognition A.
The Association of British Pharmaceutical Industries (ABPI), in commenting on the introduction of the International Recognition Procedure through its website MHRA’s new International Recognition Procedure (IRP): how does it shape up? (abpi.org.uk), has acknowledged the flexibility provided by the scheme while noting that businesses seeking to bring innovative medicinal products to market are unlikely to be able to benefit from the faster Recognition A process.
It has also queried whether the new procedure will achieve MHRA’s objective of faster product approvals and faster access for UK patients, noting that it depends on the MHRA waiting for the product to be approved elsewhere.
Accordingly, it has called for a ‘clearer narrative on the MHRA’s regulatory flexibilities and the impact of the IRP, not only as a route to market and patient access but also on other activities such as engaging with the ILAP and the Early Access to Medicines Scheme (EAMS), siting clinical trials in the UK and seeking scientific advice’.
We will continue to monitor how the procedure and MHRA’s approach to its application develops as the scheme matures.