01 Mar, 2024 MHRA grants first medicine approval via the new International Recognition Procedure By Jamie Hatzel For the very first time, the MHRA has a granted a UK marketing authorisation (UKMA) for a medicine through its new International...
25 Sep, 2023 MHRA simplifies legal representative requirements for clinical investigations in Northern Ireland By Jamie Hatzel Since Brexit, the UK has been subject to two separate regulatory frameworks on medical devices. Great Britain is subject to the Medical...
23 Aug, 2023 A deep dive on new UK post-market surveillance rules By Jamie Hatzel The UK government recently released a draft copy of a statutory instrument which will introduce new post-market surveillance (PMS) rules...
28 Jul, 2023 New UK post-market surveillance rules for medical devices released By Jamie Hatzel The UK government recently released the text of a new draft statutory instrument (SI) which will update the post-market surveillance...
11 Jul, 2023 Curtain raised on New Genomic Techniques Regulation By Bristows European Commission proposes to ease the regulatory burden for gene-edited plants. But when will it become law, and in what form? The...
12 May, 2023 Government announces post-Brexit changes to employment law By Emily Atkinson On Wednesday, 10 May, the Government announced a U-turn on the sunset provisions in the Retained EU Law (Revocation and Reform) Bill,...
15 Nov, 2022 UKCA marking for industrial products postponed (again) By Jamie Hatzel In yet another setback to the UK's implementation of an independent regulatory framework following Brexit, the government has once again...
10 Oct, 2022 UK Blood, Tissues and Cells: EU harmonisation in the works By Hugo Kent-Egan In June, the European Commission adopted the proposal for a regulation on standards of quality and safety for substances of human origin...
23 Sep, 2022 The tax highlights in the “Mini” Budget 2022 By Bristows Chancellor Kwasi Kwarteng "mini" budget has been revealed...but "the announcements made were anything but mini", our tax expert Miranda...
21 Jul, 2022 European Council approves EU’s accession to the Hague Judgments Convention By Ben Coleman The Council of the European Union has approved the EU’s accession to the Hague Convention on the Recognition and Enforcement of Foreign...
12 Jul, 2022 Proposals to reform secondary fundraising rules By Samuel Munday The FT has reported on a draft set of recommendations, prepared by Mark Austin, chair of the UK Secondary Capital Raising Review, to...
27 Jun, 2022 MHRA publishes response to UK MDR consultation By Jamie Hatzel The MHRA has now published the Department for Health and Social Care (DHSC) response to the public consultation on future changes to the...