The UK’s medicine safety watchdog has asked for views on how it could behave as a stand-alone regulatory body in the event of a no-deal Brexit with no implementation period.
The Medicine and Healthcare products Regulatory Agency (MHRA) has published proposals on how it could operate as a stand-alone medicines and devices regulator – taking over any decisions and carrying out functions that are currently performed at EU level – after Brexit.
Under the proposals, the MHRA would have exclusive responsibility for decisions around marketing authorisations, paediatric investigation plans and orphan drug status, in addition to its existing pharmacovigilance role.
Ian Hudson, chief executive officer of the MHRA, said: “We want to retain a close working partnership with the EU to make sure patients continue to have timely access to safe medicines and medical devices. However, it is important for the UK to prepare for all scenarios and this consultation is a key part of that.”
The agency is determined that patients should not be disadvantaged post-Brexit, that innovators should still be able to take their products to the UK market as “quickly and simply” as possible, and that the UK would continue its leading role in promoting public health, Hudson said.
The consultation includes proposed changes to the MHRA’s marketing authorisation system – for both existing and new products – such as amendments to product packaging, clinical trial procedures and data access.
The consultation, which is taking submissions until 1 November 2018, also focuses on revisions that would be necessary to four statutory instruments: the Medicines for Human Use (Clinical Trials) Regulations 2004, the Medical Devices Regulations 2002, the Human Medicines Regulations 2012 (HMRs), and the Medicines (Products for Human Use) (Fees) Regulations 2016. It has been proposed that the instruments should be amended to remove references to the EU and replace them with references to the UK.