MHRA Offers Guidance for Trials in Event of ‘No-Deal’ Brexit
While the odds of a “no deal” on Brexit remain slim, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has offered some guidance for sponsors of clinical trials.“With talks ongoing, we remain committed to reaching agreement in the Autumn,” MHRA said Friday.
The regulator encouraged sponsors of clinical trials in the UK to consider their supply chains for investigational products (IMPs) ahead of the 29 March 2019 deadline.
“Clinical Trials that use IMPs which come from or via the EU/EEA will need to ensure appropriate arrangements to assure supplies in the event of any possible border delays that may arise in the short term in the unlikely event of a no-deal Exit,” the guidance says.
The regulator also advises companies to start making contingency arrangements to provide assurances for the trials and participants.
Other guidance related to Brexit and life science companies is available here.
By 1 November, MHRA is seeking answers to various questions in a consultation, including on a new targeted assessment process for new applications for products containing new active substances or biosimilars which have been submitted to the European Medicines Agency and received a Committee for Medicinal Products for Human Use (CHMP) positive opinion.