British pharma industry responds to new Brexit guidance from MHRA

The ABPI has responded to new guidance, intended to prepare pharma companies for the end of the Brexit transition period, from the MHRA.

Brexit and medicine

The Association of the British Pharmaceutical Industry (ABPI) has responded to new guidance, published by the UK Medicines and Healthcare products Regulatory Agency (MHRA), that prepares pharmaceutical companies for the end of the Brexit transition period. 

According to the MHRA, the guidance provides information on how to operate from 1 January 2021, including the licensing of medicines and devices, clinical trials, exporting active substances for medicines, importing medicines and investigational medicinal products, pharmacovigilance procedures and new IT systems.

While the guidance is largely similar to the Brexit ‘no deal’ guidance published in 2019 (which was withdrawn as a deal was secured), there are some additions relating to the added complexity of the Northern Ireland protocol and a more time-restricted acceptance of EU batch testing and release. 

In response to the new guidance, Richard Torbett, Chief Executive of the ABPI, said: Our members will be reassured that the government has provided some critical information to help them continue preparations for the end of the transition. 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 National Health Service (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. However, we have always said that the best way to avoid disruption in the long term is for both sides to consider the impact on patients in the UK and the EU and agree a deal.”

However, according to the ABPI, further guidance is still required; pharmaceutical companies are still waiting for the MHRA to provide additional technical information on other issues such as the handling of Decentralised [DCP] and Mutual Recognition Procedures [MRP], how variations to Marketing Authorisations (MAs) will be handled and new assessment routes from 1 January 2021. Companies are also still waiting for detailed guidance on the regulation of medicines in Northern Ireland.

Furthermore, more detail is needed as even with the guidance, 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. The MHRA will need to be available to work through the detail on an individual company basis, given the complexity of medicines regulation.

More consideration is also needed for the future, the ABPI says. Alongside planning for the end of the Brexit transition period, the pharma industry is working with the MHRA to ensure that the UK remains at the forefront of medicines regulation.

The ABPI explains that by expanding the work it does with other regulators around the world to quickly adopt new breakthroughs, exploring new routes for approving medicines and aligning standards with the best in the world, the UK would be an attractive destination for pharmaceutical companies to submit their research.