3 March 2022 Blog ABPI Consultation on new industry principles for the use of health data The ABPI is proposing a new set of principles to improve public trust and transparency around the use of health data. Share this article Bookmark this page 2 min read
7 February 2022 Blog Good Machine Learning Practice for medical devices We look at the Good Machine Learning Practice guidance for medical devices drawn up jointly by regulators in the US, Canada and the UK. Share this article Bookmark this page 3 min read
20 December 2021 Blog Is pharmaceutical research and development work obvious? Pharmaceutical research and development activity involves substantial investment and ingenuity. Should this be taken for granted when assessing the inventiveness of pharma patents? Share this article Bookmark this page 4 min read
17 December 2021 Blog Cell and gene therapies: how to encourage and promote the move to market Share this article Bookmark this page 4 min read
12 November 2021 Blog The ABPI sets out its stall for the future of medicines regulation We take a look at the ABPI's Vision Paper on UK medicines regulatory policy and global influence in a post-pandemic world. Share this article Bookmark this page 2 min read
29 September 2021 Blog An opportunity to shape the UK medical devices regime The EU is now well on its way to completing the roll out of its new regulatory system for medical devices. The Medical Devices Regulation is now in force, and the In Vitro Diagnostics Regulation will follow next May... Share this article Bookmark this page 3 min read
24 August 2021 Blog EU clinical trials portal to go live in early 2022 It has been a while, but the EU Clinical Trials Information System (CTIS) is set to go live on 31 January 2022. This means that the system set up in 2014 under the Clinical Trials Regulation will finally come into effect. Share this article Bookmark this page 2 min read
29 July 2021 Blog UK regulator cracks down on anti-competitive practices UK watchdog, the Competition and Markets Authority (CMA), is coming down hard on anti-competitive pricing practices. Following hot on the heels of fines totalling over £260m for competition breaches relating to the supply of hydrocortisone tablets... Share this article Bookmark this page 2 min read
8 July 2021 Blog A new subsidy control system Simon Elsegood explains how this will change public sector investment aimed at developing the economy, following the UK's departure from the EU... Share this article Bookmark this page 1 min read
6 July 2021 Blog UK plans to boost pharmacovigilance and data collection on medicines The UK Government has published draft legislation targeting a major restructuring of the National Health Service. This will see the abolition of CCGs (Clinical Commissioning Groups) and the creation of statutory Integrated Care Systems (ICSs). Share this article Bookmark this page 2 min read
27 June 2021 Blog Data protection adequacy decisions - just in time The EU has adopted final versions of the two adequacy decisions that were issued in draft earlier this year. These permit personal data flows to the UK under the GDPR and the Law Enforcement Directive. Share this article Bookmark this page 1 min read
6 June 2021 Blog The 2021 ABPI Code takes effect soon The UK pharma sector is readying itself for the introduction of the new ABPI Code, bringing in extensive changes to the industry's self-regulatory system. Share this article Bookmark this page 1 min read