The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday reassured drugmakers that there will be no sudden changes to the country's regulatory framework when it leaves the EU in March 2019.
In December, the UK and European Council agreed to advance Brexit negotiations to a second phase , and adopted guidelines for the continued talks, noting the UK's preference for a limited transition period under EU rules and regulations. The UK and EU also issued a joint report one week prior to affirming that products placed on the market before the UK's withdrawal should be able to remain on the market in both jurisdictions without modification or re-labeling.
Last week, the Financial Times also reported that the UK hopes to continue to follow EU regulations for medicines in order to minimize disruption to the biopharmaceutical sector.
"As the UK enters the second phase of negotiations, its position on medicines regulation remains clear. The UK is fully committed to continuing the close working relationship with its European partners, in the interests of public health and safety," MHRA said.
But, in response to industry concerns over a no-deal scenario with EMA, MHRA reassured industry there would not be an abrupt shift in regulatory requirements and that it would take a pragmatic approach to promulgating new regulations.
"The European Union (Withdrawal) Bill will convert the exiting EU legislative framework into UK law at the moment of exit, so there would be no sudden changes to the UK regulatory framework," MHRA said.
Both the Association of the British Pharmaceutical Industry (ABPI) and UK Bioindustry Association (BIA) reacted positively to MHRA's statement and welcomed the agency's reassurance that it would take a pragmatic approach to instituting new regulatory requirements if a deal with the EU is not reached.
"Planning for this scenario does, however, require further detail, and further highlights why a realistic implementation period needs to be urgently agreed," ABPI said, warning of "very real consequences" for patients and the public health if favorable terms are not reached.
In the meantime, MHRA reminds companies that the UK is still an EU member state and that the agency continues to bid for EMA work. MHRA also said it is working "to ensure business continuity where procedures are likely to run beyond" March 2019, when the UK will officially leave the EU.
MHRA