As previously discussed in our article on Brexit-related challenges for the life sciences sector dated 12 February 2021, batch testing was omitted from the Trade and Cooperation Agreement (TCA) signed by the UK and EU on 30 December 2020. Whilst the EU is yet to grant recognition of batch testing,…
In response to the Conservative Party’s manifesto promise, both industry and government have agreed to make production of new drugs to patients as attractive and innovation-embracing as possible. This, coupled with MHRA emerging from under the European Medicines Agency to function as a wholly independent body, presents an ongoing challenge.…
On 28 January 2021 the Association of the British Pharmaceutical Industry (ABPI) and BioIndustry Association (BIA) held a special Brexit Lead Network to review the outcome of the Brexit deal for the life sciences sector. Government experts joined the panel to discuss details of the deal, what comes next, and…
On September 1, 2020, the UK’s medicines and medical devices regulator released the MHRA post-transition information, an extensive suite of guidance on the UK regulatory regime post the Transition Period expiring on December 31, 2020. The new guidance spreads out across dozens of documents covering the following topics: Clinical trialsDevicesLicensingImporting…