As part of the shift towards a risk-proportionate regulatory framework, the MHRA’s Clinical Trials Unit ran a Route B substantial modifications pilot from 1 October 2025 to 31 March 2026 to test a new process to streamline the review of …

From 12 February 2026, amendments to the EU Commission Implementing Regulation (CIR) 520/2012 come into effect. While the UK operates an independent regulatory system, these changes have practical implications for some UK-authorised products, particularly in relation to pharmacovigilance (PV) requirements. …

The MHRA’s inspectorate and the Defective Medicines Report Centre (DMRC) are actively liaising with NHS and Specialist Pharmacy Services (SPS), following an increase in reports of Bacillus contamination in aseptic facilities. While no firm link has been identified between these …

On 28 April 2026, new regulations for Clinical Trials will come into effect – the most significant updates in two decades. To support a smooth transition, the Medicines and Healthcare products Regulatory Agency (MHRA) and the Health Research Authority (HRA) …

The use of automation in healthcare is helping transform how patient care is delivered and robotic dispensing systems and barcode verification are now widespread amongst pharmacy operations across both primary and secondary environments, aiming to reduce human error and improve …

In six months’ time, on 28 April 2026, the most significant update to UK clinical trials regulations in two decades will come into force. This will be a pivotal moment for the evolving clinical trial landscape and marks a new …

September 2025: This blog provides information about the Route B substantial modifications and why you should sign up to take part in the pilot if you are eligible. We developed new clinical trial legislation in collaboration with the Health Research …

Decentralised Manufacturing (DM) is the overarching term used in the UK to cover the two elements of the new manufacturing and supply framework: point of care (POC) and modular manufacturing (MM). A cross-agency team of Quality and Clinical Trial assessors, …

This Blog relates to actions which licence holders should do following the issuing of USFDA Warning Letters.  The MHRA’s Inspection Action Groups (IAG) are responsible for recommending and implementing regulatory action against companies for breaches across all GxPs, and its …

The aviation and marine sectors are a journey away from the traditional scope of a Wholesale Dealer’s Licence (WDA(H)), and one of unique and specific challenges. The lorries and trucks that supply medicines to hospitals and pharmacies also head to …