The Cell and Gene Therapy Catapult has outlined the latest guidance on the development and marketing of ATMPs in the UK.
The UK is now a third country with respect to the EU and as such there have been substantial regulatory changes that must be considered in the development, manufacture, and supply of ATMPs (licensed or for clinical trial).
The guidance covers legislative changes as a result of the United Kingdom leaving the European Union. It includes topics such as clinical trials, ATMP classifications, UK Marketing Authorisations, UK Paediatric Investigation Plans, orphan drug designation, MHRA submission platform and advice meetings.
The current approach for CGTC on the management of the changes in regulatory areas resulting from Brexit is to continue to monitor, review, and ensure compliance with the relevant requirements for the development and manufacture of ATMPs, the conduct of clinical trials and marketing authorisation applications within the UK, the EU, and international regions.
With regards to Brexit, divergences between EU and UK law are being actively monitored and the impact to regulatory strategy and long-term plans will be communicated to our collaborators.