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2025 Horizons Life Sciences and Health Care

In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more

Updated roadmap for UK medical device reforms published by the MHRA

On 11 December 2024, the MHRA published a revised roadmap for the long-awaited reforms to the UK Medical Device Regulations 2002 (MDR Roadmap). The updated MDR Roadmap provides additional clarity for industry on the intended...more

Framework amending the UK clinical trial regulations laid before Parliament

On 12 December 2024 the statutory instrument to amend the Medicines for Human Use (Clinical Trials) Regulations 2004 (UK CTR) was laid before Parliament. The Medicines and Healthcare products Regulatory Agency (MHRA),...more

Regulation for medicines manufactured at the point of care introduced before UK Parliament

The UK's Medicines and Healthcare products Regulatory Agency ("MHRA") has announced first-of-its-kind legislation to better facilitate the manufacture and delivery to patients of medicines that are manufactured at or near the...more

Getting to the point (of care): regulation for medicines manufactured at the point of care introduced before UK Parliament

The UK's Medicines and Healthcare products Regulatory Agency ("MHRA") has announced first-of-its-kind legislation to better facilitate the manufacture and delivery to patients of medicines that are manufactured at or near the...more

Safety first: MHRA response to UK medical device regulation consultation

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its response to its consultation on the future regulation of medical devices in the United Kingdom which ran between September and November...more

UK ABPI transfer of value disclosures: transitioning from consent to legitimate interests

UK pharmaceutical companies have historically relied upon consent as the lawful basis for the disclosure of healthcare professionals’ personal data relating to transfers of value. However, the low consent rates and the...more

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