EMA regulatory decisions after BREXIT

EMA regulatory decisions after BREXIT


The UK will follow EMA regulatory decisions for 2 years after BREXIT and is looking to speed up regulatory access in the longer term

Despite the Brexit process taking a backseat to the pandemic this year, the looming 31st December deadline for the UK’s exit from the European Union remains a significant date in the calendar. One of the key questions for the pharmaceutical industry has been how the responsibility of licencing decisions will be transferred from the European Medicines Agency (EMA) to the MHRA (The Medicines and Healthcare products Regulatory Agency). Yesterday, the MHRA announced their plans for this transition.

For a period of 2 years following 1st January 2021, the UK will continue to adopt decisions taken by the European Commission on the approval of new marketing authorisations. Following Committee for Medicinal Products for Human Use (CHMP) positive opinion for the EMA application, companies will be required to submit an identical application to the MHRA. The MHRA will then wait for and follow the European Commission (EC) decision on whether market authorisation has been granted.

Where drugs have followed the decentralised/mutual recognition procedures (the licencing of drugs in specific member states, rather than the centralised procedure for all member states), the UK can also consider the decisions of other EU member states.

The short-term implications for manufacturers is that there are minimal new hurdles for gaining regulatory access in the UK and companies planning to submit to EMA should still consider the UK part of their launch strategy.

The MHRA also intend to design three separate assessment pathways, presumably for drugs seeking UK authorisation only:

New medicines

In an effort to reduce the time to patient access for new medicines, the MHRA will develop a “roadmap” from product development to patient access for medicines given a ‘new medicine designation’. Developed in partnership with other UK organisations (e.g. NICE), this roadmap will provide a toolkit of support options to assist evidence generation during the development state. Further information on this roadmap will be published by December.

Accelerated Assessment Procedure

From 1 January 2021, MHRA will introduce an accelerated procedure that reaches a marketing authorisation decision within 150 days of application. This will consist of two assessment phases, separated by a stop-clock period of 90 days in which the manufacturer can answer questions raised by MHRA. Following the accelerated assessment procedure, a Public Assessment Report for the product will be published.

It is currently unclear which medicines will qualify for this procedure. The current MHRA position is that “good quality new marketing authorisation applications for both new and existing active substances and submitted directly to UK” will be eligible, as well as those seeking an orphan market authorisation approval.

Rolling review route

Additionally, there will be a new “rolling review” MA application route which will involve phased evaluation (possibly module by module) to provide on-going regulatory input and feedback. The final phase will “involve submission of a complete application including updated versions of the modules evaluated previously”. This route is intended to enhance the development of novel medicines and increase the efficiency of the application process by reducing the chance of negative assessment. It appears that this route will be available for any new active substance, as well as biological products and biosimilars

Market access implications

It does appear that the MHRA are actively seeking to integrate the regulatory process with the NICE assessment process, which should further underline the importance of early P&MA involvement in the product development process.

At this early stage, however, it is difficult to predict the impact of the transition on regulatory approval times, and the subsequent impact on the timing of product market access and launch. Presumably, after the two years are passed, every manufacturer seeking a marketing authorisation in the UK will have to follow one of the proposed pathways in addition to the EMA process. One can speculate that smaller companies may prioritise EMA approval over UK approval, resulting in longer waiting times for access to innovative medicines in the UK.

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