UK publishes further no-deal Brexit guidance for medicines
The UK government has published further guidance on the regulation of medicines, medical devices and clinical trials in the event of a no-deal Brexit.
LSIPR previously reported on UK preparations for regulating the domestic sector in the event of no-deal.
The latest guidelines, published on Thursday, January 3, outline plans for the Medicines and Healthcare Products Regulatory Agency (MHRA) to take over many of the currently existing functions of EU regulation.
UK participation in the European medicines regulatory network is to cease in the event of no-deal, the guidelines reaffirmed. The MHRA would take over the regulatory functions currently undertaken by the EU, including the assessment of periodic safety update reports and post-authorisation safety studies.
According to the government, all “centrally authorised products” (CAPs) currently approved by the EU would be granted a UK marketing authorisation (MA) on March 29, 2019, when the UK is due to leave the EU. MA holders would have one year from the day of Brexit to provide the MHRA with “baseline data” for CAPs converted into MAs.
The government also confirmed plans for new assessment procedures offered by the MHRA. These include a full accelerated assessment of no more than 150 days available to drugs with new active substances, and a “rolling review” for new active substances and biosimilars carried out throughout the product’s development.
The government also committed to identifying options for reducing the UK’s current licensing timetable from 210 days to 180 days.
Medicines designated as ‘orphan drugs’, which are used to treat rare diseases, would continue to benefit from a ten-year period of marketing exclusivity, as they do under current EU regulations, the guidelines confirmed.
This status will be awarded based on the same criteria as in the EU, as well as UK-specific factors such as the prevalence of the relevant disease in the UK and the availability of suitable alternatives.
The government also confirmed that the MHRA will give the pharmaceutical industry until the end of 2021 to amend product packaging and leaflets to comply with UK regulations.
With respect to the regulation of medical devices, the guidelines indicated that products in compliance with EU regulation will be allowed on the UK market for a non-specified “time-limited period”. Products approved by UK-based notified bodies will also be approved for the UK market after March 29.
The UK will also look to largely align the regulation of clinical trials with EU regulation in the event of no-deal. The EU Clinical Trials Regulation (CTR) 536/2014 is expected to come into force this year, according to the European Commission.
Although EU regulations not in effect at the time of Brexit would not be immediately integrated into UK legislation, the government reiterated its “clear commitment to align where possible with the CTR without delay”.
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