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An independent future for the MHRA 9 Sep 2020

With the global pandemic continuing to cause immense disruption, the looming issue of Brexit has taken a backseat in both the mainstream and industry press.  However, for the UK pharmaceutical industry, one key change Brexit will usher in is that, from 1 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be making independent regulatory decisions.

Of course, the MHRA as we know it today is no stranger to change.  It was established in 2003 when the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA) merged.  It evolved further in April 2013, when it joined together with the National Institute for Biological Standards and Control (NIBSC).  Now, it must reinvent itself once again to become a fully standalone medicine and medical devices regulator for the UK.

In preparation, the body issued a comprehensive set of twelve guidances, available here, explaining how the new status would affect the licensing of medicines following the 1 January 2021.  Beyond the area of licensing, there are a comprehensive set of procedures to cover imports and exports, IT Systems, and Pharmacovigilance.  This guidance release is a positive step forward in our preparations.

In response, the ABPI made a statement welcoming the provision of the guidance but calling for additional information and advice for its members.  Notably, the ABPI was keen to stress the need for further technical information on the handling of Decentralized [DCP] and Mutual Recognition Procedures [MRP], and, notably on the handling of variations to Marketing Authorisations (MAs).

The ABPI also pointed out that while the guidance provides an invaluable framework “pharmaceutical companies are going to face a significant change in the way they need to operate and will have to work through the practicalities of implementing the guidance.”  They urged the MHRA to make themselves available to help individual pharmaceutical companies navigate the changes.

Richard Torbett, the Chief Executive of the ABPI said, “Companies face significant changes in how the complex environment for medicines regulations will operate in 2021.  If we are to ensure uninterrupted supply for the NHS from January, the MHRA must continue to work closely with them on details related to individual medicines as well as on issues related to the Northern Ireland Protocol and on other areas of regulation.”

Mr Torbett makes a vital point.  Any significant change such as this will bring with it a host of associated challenges and questions that will require support.

As those of us who have worked through significant organisation changes know, the devil is usually in the detail.  That detail will need to be handled with care and diligence by those of us doing the regulatory and medical affairs groundwork every day.

The months ahead may be uncertain.  Despite the uncertainty, we should remain optimistic that the UK is continuing to do industry-leading science, and the MHRA in its new guise will strive to ensure that patients get rapid access to novel, safe and effective medicines.  With much-needed new therapies and vaccines on the horizon to address the coronavirus pandemic, we should all lend the MHRA the full weight of our support and best wishes for the future.

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