The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued new guidance on Thursday to propose and further clarify certain regulatory positions in case of a “no-deal” scenario as Brexit looms around the corner.
The 14-page guidance document covers the current and possible future regulatory space for medicines and medical devices brought into the UK market, as well as clinical trials conducted in the UK. It was developed based on responses to MHRA’s October call
for industry viewpoints on how existing legislation and regulatory processes would likely require modifications in the event the UK and the EU do not reach a deal on continuing resolutions, following the 29 March deadline for the Brexit transition.
Throughout 2018, MHRA stressed the unlikelihood of the ongoing negotiations between the UK and the EU failing to result in a deal. Yet its updated guidance proposed arrangements to modify regulations under a no-deal exit, indicating less confidence that Parliament will approve the deal
negotiated with the EU. “It has always been the case that as we get nearer to that date, preparations for a no-deal scenario would have to be accelerated,” MHRA noted. “We must ensure plans are in place should they need to be relied upon.”
MHRA has sought to ease industry concerns by providing clarity around any preparations
for post-Brexit scenarios, though its guidance continues to be rather bleak. A set of MHRA guidance documents was posted
in August to aid drug and device companies in preparing for Brexit's implementation, which is set to end by December 2020. With MHRA's release
in October 2018 of a Brexit no-deal guidance for clinical trial sponsors, the scenario was still considered an “unlikely” outcome and the agency intended to secure a deal by autumn.
MHRA’s updated guidance for industry focuses exclusively on a “no-deal” scenario. The agency calls it a “more comprehensive version” of the technical information notice published
in August 2018.
The guidance sets forth proposed strategies that are largely focused on pharmaceuticals. There are seven “key arrangements” identified as part of a no-deal Brexit for the pharmaceutical sector, followed by three for clinical trials and just two for medical devices.
The regulatory landscape is perhaps slightly more straightforward to work out for the desired future pharmaceutical space as marketing decisions made by the European Medicines Agency do not rely on Member States, as is the case for devices. The EU’s medical device and in vitro
diagnostic regulations (MDR/IVDR) complicate plans even further in terms of the UK’s Brexit preparations. MHRA noted the UK “will have a regulatory system in place on 30 March 2019” to “mirror all the key elements” in MDR/IVDR. The agency also intends to follow the same 2020/2022 transitions for MDR/IVDR, respectively, as in the EU.
In January 2018, MHRA had stated
“there would be no sudden changes to the UK regulatory framework” on the drug side. Certain arrangements proposed via the updated guidance, including the adoption of a risk-based approach to additional laboratory testing for drug products, among others, would go into force as early as March and April. Time-sensitive device arrangements include making postmarket surveillance decisions independently from those of the EU, an expanded registration process and a new UK representative role.
A newly proposed arrangement that is likely to be well-received by industry relates to allowing for currently CE marked devices to stay on the UK market if there is no deal post-Brexit for “a time-limited period.” Relevant medical device labeling requirements would continue to apply. “Further detail on the future process for brining a medical device onto the UK market will be subject to consultation in due course,” MHRA said. “For any future changes to requirements, adequate time will be provided for business to implement these.”
It is also being proposed for the EU to cease recognizing new medical devices seeking CE marking by UK-based notified bodies (NBs) in a no-deal exit, underscoring the lack of clarity for new medical products seeking EU rather than UK market entry. Yet MHRA intends to grant UK-based NBs “an ongoing legal status” to ensure continued supply of medical devices to the UK.
The arrangement for an expanded registration process seeks to extend requirements to include all medical devices, active implantable devices, IVDs and custom-made devices over class-specific grace periods.
MHRA also clarified that further guidance on certain proposed drug routes will come “in due course.” These relate to grandfathering marketing authorizations (MAs), new MA procedures for products containing new active substances and biosimilars, free scientific advice to UK-based small and medium-sized enterprises, submissions of pediatric investigation plans and studies, a new “Responsible Person for Import” role, as well as requirements for abridged applications to obtain MAs in the UK and independent re-testing of pharmaceuticals.
Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal