Data protection essentials

MHRA issues statement of policy intent regarding early access to innovative medical devices

Life Sciences analysis: On 31 July 2025, the Medicines and Healthcare Products Regulatory Agency (MHRA) issued a statement of policy intent relating to a service to provide early access to the Great Britain market for innovative medical devices (Early Access Service). Although this statement is non-binding, it indicates further efforts by the MHRA to reduce unwarranted barriers to market entry, through faster, risk-proportionate, and predictable routes to regulatory approval—in line with Action 25 of the Life Sciences Sector Plan (published on 16 July 2025). Sarah Cowlishaw & Dan Spivey of Covington & Burling LLP consider the issues at hand.

MHRA guidance for pilot streamlining assessment of Route B substantial modifications to clinical trial approvals

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on plans to streamline the assessment of some substantial modifications to clinical trial approvals. Although these modifications are referred to as 'substantial', they do not introduce significant new safety concerns and are subject to a risk-proportionate review instead of a full assessment. The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 established two types of substantial modifications to studies that require authorisation. Section 11B sets out the criteria for what constitutes Route B substantial modifications. Companies that apply for Route B modifications will automatically receive approval within 14 days unless the licensing authority intervenes. The agency's commitment to the timeline may result in a staged rollout if the pilot program is oversubscribed. The regulations that create Route B will come into force in April 2026, but MHRA is encouraging companies to take part in a pilot project that is scheduled to start in October 2025 and finish at the end of March 2026.

UPC won't refer costs questions to top EU court

Law360, London: The Unified Patent Court (UPC) said 20 August 2025 that it cannot refer questions of its framework or procedures to the EU's top court, ruling that such issues fall outside the EU's jurisdiction.

Swissmedic publishes 2024 benchmarking study on drug authorisation times

The Swiss Agency for Therapeutic Products (Swissmedic) has published its 12th annual benchmarking study, comparing its drug authorisation times with the European Medicines Agency (EMA) and US Food and Drug Administration (FDA). The study assessed throughput times for completed applications with positive decisions in 2024, covering 46 NASs, 70 additional indications, 118 known active substances, and 23 extensions. Data for Swissmedic procedures were sourced directly from the authority, while international comparisons were based on 127 applications submitted to Swissmedic, representing 47.9% of the total. Swissmedic’s throughput times for NASs remained stable compared to 2023, with a slight increase observed in applications processed under Article 13 of the Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA). Throughput times for additional indications decreased by 10%.