Update on the UK Medicines Regulator Post Brexit

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has joined the Australia-Canada-Singapore-Switzerland (ACSS) Consortium, with effect from 1 January 2021.

The group will be renamed as the Access Consortium to reflect the addition of the UK, which increases the combined population of the participating countries to approximately 145 million. Pharmaceutical companies that submit applications to some or all of the five Access countries may have their products evaluated for marketing in those countries simultaneously, with reduced evaluation times. Updated guidance to industry on how to apply for a product to be considered for marketing authorisation across the five member countries, including the UK, will be provided by the Consortium in due course.

The MHRA is one of the world's leading regulators of therapeutic products and it is to be hoped that membership of the well-established collaboration group will help to maintain this status, whilst also helping to ensure timely access to medicines in the UK and the other member countries. UK marketing authorisations secured by this route may be used by UK patent owners as the basis to apply for supplementary protection certificates covering the UK.