Weekly highlights

Weekly highlights

Each week we provide a round-up of key legal developments in the life sciences sector curated by our life sciences legal team. This includes

To view the latest version of this document and thousands of others like it, sign-in with LexisNexis or register for a free trial.

TAKE A FREE TRIAL

Latest Life Sciences News

NHS HRA launches consultation on changes to model Clinical Trial Agreement

The NHS Health Research Authority (HRA), acting on behalf of the UK's Four Nations Contract Leads, has launched a consultation on proposed changes to the model Clinical Trial Agreement (mCTA) and related commercial template agreements. Key proposed modifications include (1) removal of the definition of 'Affiliate'; (2) adjustment of e-archiving fees to £1,000; (3) inclusion of new clauses addressing home health care providers and compliance with the US anti-kickback statute and (4) revisions to termination clauses. The draft agreement also incorporates updates to align with the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, SI 2025/538, which come into force on 28 April 2026. The consultation closes on 30 November 2025. The Four Nations Contract Leads plan to update and align the model non-commercial agreement with SI 2025/538 before the regulations take effect.

Commission launches pilot coordinated assessment for medical device clinical investigations

The European Commission has launched a pilot programme for the coordinated assessment of clinical investigations and performance studies under the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746. This initiative allows sponsors to submit a single application for studies conducted across multiple Member States, aiming to streamline regulatory processes, enhance transparency, and reduce administrative burdens. Eligible sponsors must be conducting multinational studies involving at least two participating countries and using specified categories of investigational devices. Applications must be submitted by 30 April 2026.

MHRA closure of RegulatoryConnect programme to track regulatory assessments

The Medicines and Healthcare products Regulatory Agency (MHRA) has decided to close its RegulatoryConnect program after assessing how much it will cost to complete the system. MHRA proposed RegulatoryConnect last year as a way to make it easier for industry to see and track their regulatory assessments when it shared guidance on the project. MHRA envisaged users signing into the portal to track the progress of applications and see live license details with plans to add the ability to file applications and variations through the service later. 'The functionality to track applications and view live authorisation details through the existing portal will remain available,' but 'the program no longer offers value for money for UK taxpayers' according to MHRA. MHRA is planning a replacement that aligns with the strategy it intends to publish next year.

MHRA publishes study establishing quality standards for global microbiome research

The Medicines and Healthcare products Regulatory Authority (MHRA) has published a study involving 23 laboratories from 11 countries, revealing significant variability in global microbiome research methods. The study tested identical samples using World Health Organization International Reference Reagents, which contain DNA from known bacterial compositions. Results showed that species identification accuracy ranged from 63% to 100% across different methods, false positive rates varied between 0% and 41% and sample diversity estimates differed markedly—from 12 to 185 bacterial species in the same sample. Based on these findings, the research establishes Minimum Quality Criteria for four key reporting measures that laboratories can use to validate their microbiome analysis methods.