March 29 marked the one-year countdown to the UK’s exit – Brexit – from the European Union (EU).
According to member organisation RAPS (Regulatory Affairs Professionals Society), trade and regulatory agreements between the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) remain uncertain.
“It is still unclear what the relationship between the MHRA and the EMA will be after March 2019, but it is critical this is addressed soon,” executive director Paul Brooks told us.
Contract development and manufacturing organisation (CDMO) Recipharm agreed that at a regulatory level, much remains unclear at the 12-month countdown mark.
“Worryingly, there has been little guidance or clarity from the EMA to date, as it focuses on the task of relocating its operations to Amsterdam,” said senior vice president of quality management, Thomas Beck.
Recipharm has been liaising with both the EMA and relevant politicians to “communicate that the finer details of Brexit and the implications on the pharma industry need to be discussed as a matter of priority,” Beck told us.
Regarding mutually recognised site inspections between the US and EU, Beck said the best outcome would be that the EU and UK maintain their agreement, “meaning there will be limited to no immediate regulatory changes.”
The Mutual Recognition Agreement was signed between the EMA and the US Food and Drug Administration (FDA) in March last year, and recognises good manufacturing practice (GMP) inspections carried out in 11 EU Member States.
“The worst case scenario may be that patients are without medicines in the short term, which of course is extremely concerning,” said Beck.
“This may be particularly the case for products with short shelf lives that are not suited to the longer release times and additional sampling needed to satisfy the requirements of both markets,” he added.
The Final Countdown
In the lead up to Brexit, Brooks advised manufacturers to strengthen and support regulatory workforces to ensure a smooth transition.
“Companies with strong regulatory resources, intelligence and expertise will be much better prepared to optimise outcomes in the new regulatory landscape.”
“These well-prepared companies will, no doubt, position themselves to be more competitive in the European market,” he told us.
Beck also recommended drugmakers be prepared for all eventualities: “While many companies in the pharma industry are campaigning for a ‘soft’ exit from the EU, there is risk that the complexity and bureaucracy of the regulatory landscape will increase dramatically if a ‘hard’ Brexit is implemented.