Trackers

Trackers

Trackers monitor key cases, legislation, consultations, guidance documents, reports, opinions and other events for certain areas of law. See:

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Life sciences cases tracker—UK is intended to be used to track the progress of UK cases relevant to the life sciences sector
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Life sciences cases tracker—EU is intended to be used to track the progress of EU cases relevant to the life sciences sector
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Life sciences tracker—UK is intended to be used to track the progress of UK legislative proposals and current consultations relevant to the life sciences sector
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Life sciences tracker—EU is intended to be used to track the progress of EU legislative proposals and current consultations relevant to the life sciences sector
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Patents tracker—UK is intended to be used to track the progress of key patent judgments, legislative proposals and consultations in the UK
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Patents tracker—EU is intended to be used to track the progress of key patent judgments, legislative proposals

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Latest Life Sciences News

EMA launches three new priority medicines tools to support medicine development

The European Medicines Agency (EMA) has launched three new features under its priority medicines (PRIME) scheme, following a two-year pilot, to enhance support for medicines targeting unmet medical needs. The features—a regulatory roadmap and product development tracker, expedited scientific advice, and a submission readiness meeting—aim to streamline scientific dialogue, provide faster responses, and help developers prepare for marketing authorisation applications. The EMA has indicated that these tools will become permanent PRIME features as it prepares for the revised EU pharmaceutical legislation.

Life Sciences weekly highlights—19 March 2026

This week's edition of Life Sciences weekly highlights includes an MLex analysis of the European Data Protection Board (EDPB) and European Data Protection Supervisor (EDPS) issuing a joint opinion on the proposed EU Biotech Act, supporting harmonisation of clinical trials rules under the proposal, but calling for specific safeguards for sensitive health data. Also included, is news that the Council of the EU has agreed its position on the Digital Omnibus on AI proposal, and that the European Parliament’s Internal Market and Consumer Protection and Civil Liberties committees have adopted their joint position, supporting proposals to simplify AI rules, including amendments to revise timelines for high-risk systems, MedTech Europe has published a joint industry statement on packaging and sustainability requirements affecting medical devices, as well as news that the House of Lords has opened an inquiry into innovation in the NHS, focusing on personalised medicine and AI, EFPIA has published research on EU competitiveness for pharmaceutical investment and updates on Innovative Health Initiative (IHI) projects tackling health challenges ranging from antimicrobial resistance and AI to big data and regulatory innovation. Further news included is that the EMA has published an implementation strategy for the revised International Council for Harmonisation (ICH) E2D(R1) pharmacovigilance guideline, and has also opened a consultation on paediatric oncology development, the EMA and the Heads of Medicines Agency (HMA) have approved a 2026–28 workplan on using AI and big data in medicines regulation, the MHRA has highlighted the potential of medicines reclassification, involving switches from prescription-only (POM) to pharmacy, general sales list and over-the-counter (OTC) status, and a key Patents Court decision in Nador Cott Protection SAS v Asda Stores Ltd confirming that a mandarin variety was not essentially derived for Plant Breeders’ Rights purposes, among other stories.

MHRA and NICE to launch aligned pathway for faster medicines approval

The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have announced an aligned pathway to synchronise licensing and value assessment decisions, aimed at enabling patients in England to access new medicines three to six months sooner. Launching on 1 April 2026, the pathway runs NICE and MHRA processes in parallel, alongside a new Integrated Scientific Advice service offering a single-entry point and aligned evidence requirements. The initiative aims to reduce delays, provide companies with clearer timelines and support clinical development planning, with first guidance expected in June 2026. This development forms part of the government’s commitments in the 10 Year Health Plan for England and Life Sciences Sector Plan.

European Parliament committees back Digital Omnibus on AI Act amendments

The European Parliament's Internal Market and Consumer Protection and Civil Liberties committees have adopted amendments to the Artificial Intelligence Act (AIA) by a vote of 101 to nine, with eight abstentions. These changes postpone compliance deadlines for high-risk AI systems. The amendments establish the following application dates: for high-risk systems, such as those involving biometrics and critical infrastructure, the deadline is now 2 December 2027; for systems covered by EU sectoral legislation, the deadline is set to 2 August 2028. Additionally, the proposals introduce a ban on AI 'nudifier' systems that create sexually explicit images without consent while extending the watermarking compliance deadline until 2 November 2026.