Business & Regulation Business Practice, Standards & Regulation

End of an Era

The UK’s medicines regulator releases new guidance for Brexit

Maryam Mahdi | 09/16/2020 | Quick Read

As the Brexit transition period comes to a close, the MHRA has issued guidance for pharma companies (1). The documents cover clinical trials, licensing, IT systems, and pharmacovigilance, and are intended to help support businesses from January 1, 2021 – the point at which the MHRA will become the UK’s sole medicines regulator. The guidance also outlines specific protocols for Northern Ireland, which shares a border with Europe.

“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,” said Richard Torbett, Chief Executive of the Association of the British Pharmaceutical Industry, in a statement responding to the news (2). “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.”

Email*

Choose a password*

I have read and understand the Privacy Notice *

Stay up to date with our other newsletters and sponsors information, tailored specifically to the fields you are interested in

I want to stay up to date with the "Small Molecule" field I want to stay up to date with the Cell and Gene field I want to stay up to date with the Bioprocessing field

When you click “Subscribe” we will email you a link, which you must click to verify the email address above and activate your subscription. If you do not receive this email, please contact us at [email protected].
If you wish to unsubscribe, you can update your preferences at any point.

Business & Regulation Business Practice, Standards & Regulation

MHRA, “MHRA post-transition period information” (2020). Available at https://bit.ly/2QOfAzK.
ABPI, “ABPI response to MHRA guidance for the end of the transition period” (2020). bit.ly/3lKt51m.

Maryam Mahdi

Deputy Editor

After finishing my degree, I envisioned a career in science communications. However, life took an unexpected turn and I ended up teaching abroad. Though the experience was amazing and I learned a great deal from it, I jumped at the opportunity to work for Texere. I'm excited to see where this new journey takes me!