On 25 July 2023, the EU Commission published its response to the European Citizens’ Initiative’s petition on “Save Cruelty-free Cosmetics – Commit to a Europe without Animal Testing”. The petition received 1.2 million signatures from EU citizens and the EU Commission must respond to petitions gathering 1 million signatures or more. The EU Commission has confirmed the following in response to the requests of the petition: Protect and strengthen the cosmetics animal testing ban The…
Last month, the UK House of Commons debated the current state of regulatory and legal hurdles negatively affecting the development of psilocybin-based (the psychedelic compound most commonly found in ‘magic mushrooms’) therapies for mental and physical health disorders in the UK. The debate resulted from an e-petition, which garnered 11,824 votes in February this year. The debate saw a consensus among Members of Parliament across party lines, collectively supporting the proposal for rescheduling psilocybin from…
We’ve set out our top ten tips on ensuring GDPR compliance if your organisation is procuring AI solutions from third parties, whether this is to train an AI imaging system, integrate AI solutions into a patient-facing app or to allow your staff to make use of generative AI. These tips are based on the issues which we see are attracting regulatory scrutiny in practice, the potential stumbling blocks we’re coming across in supplier terms, as…
As already well noted on this blog, on 26 April 2023 the European Commission published a set of proposals for the reform of EU pharmaceutical legislation. A key plank of the reforms comprises measures designed to preserve and protect the supply of medicines across the EU, in particular, critical medicines. Although many member states already have mechanisms in their armoury to protect their own supply chains, this reformatory drive to protect supply chains throughout the…
As previously covered in this blog, on 26 April 2023 the European Commission published a set of proposals for the reform of EU pharmaceutical legislation. One of the most significant aspects of the reforms is that measures to protect the environment are core. For the first time, protection of the environment will be brought to the fore of the pharmaceuticals industry, and are embedded and enshrined throughout the package. Our ESG expert within our Brussels…
At the end of last week, two European Parliament Committees published the latest version of the EU AI Act. The new draft reflects months of political wrangling, but it also demonstrates that EU legislators have listened to the (many) criticisms levied at the EU AI Act until now. So what’s new? We’ve set our top ten changes: Higher penalties: If you thought the previous proposal was eye-watering, it’s about to get steeper. The most serious breaches will…
On 26 April 2023 the European Commission published its Proposals to Reform the EU pharmaceutical legislation.[1] We continue our analysis of the Proposals with this focus upon the changes concerning orphan medicines. 1.The current Orphan Regulation (EC) No 141/2000 will be repealed, and the new orphan provisions will be integrated into the general Regulation laying down the EU procedures for the authorisation and supervision of medicines. 2. The orphan designation criteria remain largely unchanged, meaning…
On 27 April 2023, the MHRA announced that the UK government intends to introduce legislation this spring that will extend the acceptance period of CE marked devices onto the Great Britain market. The MHRA’s announcement has provided much needed. This statement made by the MHRA is an update to their announcement made on 28 March 2023, on which we previously blogged. This is a very welcome step from the MHRA after what has been a…
Today the European Commission has finally published its Proposal to revise the EU Pharmaceutical legislation, the most momentous reform for over 20 years. This is an eagerly anticipated overhaul of the EU’s pharmaceutical system that has generated a lot of debate and concern since earlier leaked documents showed the far-reaching effect of the measures that were being considered and the impact these could have on the industry. The review is part of the EU’s Pharmaceutical…
On 15 March 2023 (Regulation (EU) 2023/607), the EU extended both the transition period for the EU Medical Device Regulations (EU MDR) and the validity of CE mark certificates. The new arrangements give manufacturers more time than previously anticipated to get their medical devices certified and they recognise the capacity challenges faced by notified bodies. Higher-risk devices now have until 31 December 2027 to ensure that they comply with EU MDR requirements and medium to…