Regulatory Blog

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) updated the section 3.1: 'Implementation of new guidelines' through its official guidance titled Medicines: Apply for a Variation to your Marketing Authorisation   — a key reference for MA holders operating in the UK regulatory ecosystem. A variation is any change to the terms of an existing marketing authorisation, from simple administrative updates to changes that may affect quality, safety or efficacy. T

Conducting clinical investigations for medical devices in the UK requires strict adherence to MHRA’s updated regulatory framework, designed to support patient safety, device innovation, and compliance with evolving UK (and EU for Northern Ireland) requirements. The guidance  “ Notify MHRA about a clinical investigation for a medical device ” provides a clear roadmap for manufacturers, sponsors, and investigators who plan to conduct clinical investigations of medical devices i

The UK regulatory environment now offers two important pathways for bringing innovative medicinal therapies to patients: The Early Access to Medicines Scheme (EAMS) , which permits earlier availability of new medicines under conditions of unmet medical need; and The MHRA’s guidance “ Clinical trials for medicines: apply for authorisation in the UK ” , which provides the regulatory framework for initiating clinical trials of investigational medicinal products. These 2 guidance

With the regulatory landscape evolving in the UK post-Brexit, manufacturers, importers, distributors and authorised representatives must be fully aligned with the registration requirements laid out by the MHRA. The guidance titled “ Register medical devices to place on the market ”  sets out the detailed steps, legal framework, responsibilities and timelines you must meet for compliant market entry. Under the guidance, every medical device  (including in-vitro diagnostics (IV

With the 2025 amendments to the Medicines for Human Use (Clinical Trials) Regulations taking effect on 28 April 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has provided comprehensive guidance “ Clinical trials for medicines: modifying a clinical trial approval”  for sponsors and investigators which outlines how to manage changes to an approved clinical trial of a medicinal product. Types of Modification Modifications to a clinical trial approval f

The UK’s post-Brexit regulatory landscape for medical devices continues to evolve, placing renewed emphasis on safety, performance, and transparency. The Medicines and Healthcare products Regulatory Agency (MHRA) has issued clear guidance on both registering medical devices for market access and conducting clinical investigations, ensuring compliance with the UK Medical Devices Regulations 2002 (UK MDR 2002) and the Windsor Framework. This combined overview summarizes the lat

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has modernised its processes for evaluating, approving, and maintaining marketing authorisations (MAs) under a post-Brexit regulatory framework aligned with the Windsor Framework (effective January 2025). The MHRA’s guidance documents provide a clear roadmap for each of these phases: Variations to marketing authorisations (MAs)   – covers changes after a licence is granted. National Assessment Procedure for me

When the ownership of a medicine changes—through a merger, acquisition, corporate restructure, or divestiture—the marketing authorisation...

The UK’s Medicines and Healthcare products Regulatory Agency ( MHRA ) has issued a coordinated update to its suite of clinical trial...

The Medicines and Healthcare products Regulatory Agency (MHRA) provides a detailed framework for conducting clinical investigations of...

The Medicines and Healthcare products Regulatory Agency (MHRA) plays a pivotal role in regulating medicines, medical devices, and related...

On 22 August 2025 , the Medicines and Healthcare products Regulatory Agency (MHRA) published an updated version of its guidance “...

In the pharmaceutical lifecycle, there are times when a marketing authorisation holder (MAH) needs to cancel a medicine’s marketing...

Medical devices, whether diagnostic, therapeutic, or assistive, undergo rigorous scrutiny before entering the UK market. One of the most...

On 24 July 2025 , the UK Government published the latest update to its official guidance: " Regulation of medical devices in Northern...

In July 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released updated and expanded guidance on the use of...

In an era of rapid pharmaceutical innovation, global collaboration is key to expediting patient access to new therapies. To help patients...

The regulatory landscape for medical devices and digital health technologies in the UK is evolving rapidly, reflecting the growing...

Clinical trials are the cornerstone of modern medicine, ensuring that new treatments are safe, effective, and suitable for public use....

The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) has launched Phase 2 of its AI Airlock programme , supported by a...