Britain's medicines regulator has set out post-Brexit plans that aim to calm industry fears over what a regulatory break with the EU could mean for drugmakers.
While the UK will work to secure a transition period based on current EU rules, the Medicines and Healthcare products Regulatory Agency (MHRA) today said in the event of no deal and a split with the European Medicines Agency (EMA), it would be "pragmatic" in setting new UK regulatory requirements.
The EMA, which is relocating from London to Amsterdam because of Brexit, approves drugs across the EU.
In December, pharmaceutical industry leaders warned of a "nightmare scenario" for the sector if a regulatory alignment with the EU was not agreed.
If it is forced to cut ties with the EMA, the MHRA also said there would be "no sudden changes to the UK regulatory framework" and that it would "give adequate notice and ensure that companies had sufficient time to implement any changed requirements".
"We would ensure the minimum disruption and burden on companies as the UK exits the EU, while building on the existing relationship between MHRA and firms," it said.
The regulator said it would continue to engage with business, patient groups and other stakeholders to help "plan ahead with certainty", and it will publish more technical detail if appropriate.
Christiane Abouzeid, the head of regulatory affairs at the UK BioIndusry Association (BIA), said the update from the MHRA was welcome and "provides public clarity" on the UK’s current regulatory relationship with the European medicines network of member states and the EMA, as well as its planned approach to a potential no deal scenario.
"The BIA has long advocated for retaining ongoing UK regulatory cooperation with the European Union on medicines to ensure minimal disruption to patient access in both the UK and EU. This is also the UK government’s preferred outcome," Abouzeid said.
Regulation in the UK and EU is closely tied, and the two depend on each other for drugs. The UK imports 37m medicine packs from the EU each month, and it exports 45m packs to the EU per month, according to the Association of the British Pharmaceutical Industry.