04 Apr 2022 MHRA announce new scheme for monitoring good manufacturing and distributions practices in IAG cases By Taryn Jones, Teresa Hitchcock The Medicines & Healthcare products Regulatory Agency (MHRA) has announced a new supervisory scheme as part of its process for monitoring...
16 Mar 2022 UK ABPI calls for standardised international approach to university-industry collaborations By Richard Taylor, Anna Wrench The Association of the British Pharmaceutical Industry (ABPI, the UK’s leading association for pharmaceutical companies), has published a...
18 Feb 2022 Clinical Trial Regulations in the EU – how will the UK follow? By Kate Burgess The European Medicines Agency has confirmed that the new Clinical Trials Regulation is now in effect as of 31 January 2022. Please see...
13 Dec 2021 Do medical devices have systematic bias? By Kate Burgess, Anna Ward An investigation has been launched by the UK’s Department of Health and Social Care (“DHSC”) with the overall aim of improving healthcare...
17 Nov 2021 Assessing the value of medicine for diverse patients: Implications of a QALY approach for health disparities By Kirsten Axelsen Momentum and debate about the application of cost-effectiveness analysis to determine the value and prices of prescription drugs in the...
21 Sep 2021 Open consultation on the future regulation of medical devices in the United Kingdom By Richard Taylor, Elinor Cavil BackgroundThe Medicines & Healthcare products Regulatory Agency (MHRA) is holding an open consultation to gather views on possible...
22 Mar 2021 The future regulation of medical devices in the UK under the Medicines and Medical Devices Act 2021 By Kate Burgess, Anna Ward The Medicines and Medical Devices Act 2021 (the “MMD Act”) was granted royal assent on 11th February 2021. The MMD Act confers broad...
09 Mar 2021 Brexit and the MRDCRP - update on 5-digit company number By Veronika Appl On 23 February 2021, an update was published to the British Medicines and Healthcare products Regulatory Agency's (MHRA) Guidance on the...
02 Mar 2021 Telehealth - a white hot M&A market? By Moritz von Hesberg The global outlook for M&A in the digital health and particularly the telehealth sector has never been brighter than today. Telehealth’s...
28 Feb 2021 UK investment in life sciences By Victoria Rhodes At a time when the importance of the life sciences industry to our daily lives has never been clearer, the UK Government has been...
22 Feb 2021 Proposed Reform to the UK's NHS Procurement Regime By Hannah Gardiner On 11 February 2021, the Department of Health and Social Care published a white paper - Integration and innovation: working together to...
01 Nov 2017 Doctrine of equivalents: what's new in Continental Europe? By Roberto Valenti For the first time, in Eli Lilly v Actavis the UK Supreme Court has introduced a doctrine of equivalence in an effort to move closer to...