Thomas Nugent / Wikimedia Commons
The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed its continuing role in regulating medicines safety while the Brexit negotiations continue.
The UK drugs regulator took the step in response to the public statement made earlier this month (4 July) by health secretary Jeremy Hunt and business secretary Greg Clark, confirming the UK government’s desire “to retain a close working partnership in aspects of medicines regulation after the UK leaves the EU in the interest of public health and safety”.
The two secretaries of state wrote to the Financial Times outlining three principles that would underpin the challenge of developing a new regulatory system post-Brexit[1]
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The MHRA was also responding to notices issued by the European drugs safety regulator — the European Medicines Agency (EMA) — and the Human Coordination Group for Mutual Recognition and Decentralised Procedures, the body which helps to resolve any differences in marketing authorisation data involving two or more European Union (EU) member states.
The notices highlight issues that marketing authorisation holders should be considering as the UK begins talks to leave the EU, and they include an EMA question and answer document for pharmaceutical companies published by the EMA in May.
In its statement published on 17 July, the MHRA said: “Until the exit negotiations are concluded, the UK remains a full member of the EU and all the rights and obligations of EU membership remain in force[2]
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“Whatever the outcome of the negotiation, we will continue to collaborate with all involved to deliver the current speed of authorisations, access to new and innovative medicines and devices, and continue to ensure the quality, safety and efficacy of all medicines and devices, in order to safeguard an uninterrupted level of public health protection.”
It went on: “The MHRA is working closely with the government to analyse the best options and opportunities available for the safe and effective regulation of medicines and medical devices in the UK.”
References
[1] Jeremy Hunt & Greg Clark. The UK wants to continue to work with the EU on medicines. Financial Times. Available at: https://www.ft.com/content/a94326ac-5dbd-11e7-9bc8-8055f264aa8b?mhq5j=e3 (accessed July 2017)
[2] GOV.UK. MHRA and making a success of Brexit. Last updated 17 July 2017. https://www.gov.uk/government/news/medicines-and-healthcare-products-regulatory-agency-statement-on-the-outcome-of-the-eu-referendum (accessed July 2017)
