Regulatory Blog

Advanced therapy medicinal products (ATMPs) are regulated medicinal products that include gene therapy medicinal products, somatic cell therapy medicinal products, and tissue-engineered products. The Advanced Therapy Medicinal Products: Regulation and Licensing in the UK guidance explains the regulatory and licensing arrangements for ATMPs in the UK, including product classification, regulatory advice, clinical trials, marketing authorisation, combination ATMPs, manufacturing

The UK parallel import licensing scheme allows a medicine authorised in a European Economic Area (EEA) Member State to be marketed in the UK, provided the imported product has no therapeutic difference from the UK cross-referenced product. The Medicines and Healthcare products Regulatory Agency (MHRA) guidance, “Medicines: apply for a parallel import licence,” explains the requirements for obtaining and maintaining a parallel import licence, including application procedures,

Clinical trials may need to be changed during their lifecycle because of developments in trial design, participant safety, medicines, scientific information, or trial administration. The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance, Clinical trials for medicines: modifying a clinical trial approval, explaining the different types of modifications that can be made to a clinical trial approval. The amended Clinical Trials Regulations took fu

Pharmacovigilance for medicines authorised in the UK covers activities including safety information reporting, signal detection, risk management, periodic safety reporting, post-authorisation safety studies, safety reviews, post-authorisation measures, and safety communications. The Medicines and Healthcare products Regulatory Agency (MHRA) has published Guidance on pharmacovigilance procedures to explain its approach to pharmacovigilance. The guidance was updated on 21 Augus

Access to accurate, up-to-date information about medicines is important for healthcare professionals, patients, and anyone seeking to understand how a medicine should be used safely. Product information provides details about the use of medicines, their properties, and the scientific basis for marketing authorisations. The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance, Find product information about medicines, to explain how users can acc

As medical device development becomes increasingly focused on clinical evidence, sponsors and manufacturers must understand when a clinical investigation requires regulatory notification and how to manage the study throughout its lifecycle. In the UK, clinical investigations may be required to generate evidence supporting UKCA, CE or CE UKNI marking, making regulatory planning an important part of device development. The Medicines and Healthcare products Regulatory Agency (MH

Clinical investigations of medical devices require a comprehensive submission that provides the MHRA with sufficient information to assess the safety and performance of the device. The MHRA guidance Clinical Investigations: Compiling a Submission explains how manufacturers should notify the MHRA of a planned clinical investigation and sets out the information and supporting documentation required for assessment. Why This Guidance Is Important The guidance provides manufacture

Clinical investigations play an important role in generating clinical evidence to demonstrate the safety, performance, and clinical benefit of medical devices before they are placed on the market. Manufacturers and sponsors must determine when a clinical investigation is required and follow the appropriate notification procedures before commencing a study in Great Britain. The guidance documents Medical Devices That Need a Clinical Investigation and Clinical Investigations fo

Clinical investigations are an essential part of demonstrating the safety and performance of medical devices before they are placed on the market. Organizations conducting investigations in Great Britain must ensure that studies are appropriately planned, approved, and supported with complete regulatory documentation. The guidance documents Clinical Investigations in Great Britain, Approving Clinical Investigations, and Compiling a Submission outline the regulatory framework,

Efficient regulatory submissions depend not only on preparing high-quality dossiers but also on using the correct submission systems and selecting the appropriate regulatory pathway. For companies seeking to submit medicines applications, clinical trial documentation, or safety reports in the UK, understanding the Medicines and Healthcare products Regulatory Agency (MHRA) submission infrastructure is essential. The MHRA provides guidance covering two important areas: Register

The UK clinical trials regulatory framework has undergone significant changes following amendments to the Medicines for Human Use (Clinical Trials) Regulations. These changes introduce updated requirements across clinical trial conduct, safety reporting, transparency, Good Clinical Practice (GCP), investigational medicinal products, and regulatory oversight. To support sponsors and investigators, the Medicines and Healthcare products Regulatory Agency (MHRA) has published upd

Ending a clinical trial is an important regulatory milestone that requires sponsors to meet specific notification, transparency, and reporting obligations. Properly closing a trial ensures that regulatory authorities are informed, trial results are made publicly available, and participants have access to understandable information about the research in which they participated. The Medicines and Healthcare products Regulatory Agency (MHRA) has published the guidance Clinical T

Timely access to innovative medicines and biosimilars is an important objective for regulatory authorities worldwide. Collaborative assessment models enable regulators to share scientific expertise, reduce duplication of effort, and accelerate the availability of high-quality, safe, and effective medicines for patients. International work-sharing initiatives also promote regulatory convergence while maintaining robust scientific evaluation standards. The Medicines and Healthc

Access to accurate and up-to-date medicinal product information is essential for the safe prescribing, dispensing, and use of medicines. Healthcare professionals rely on authorised product information to make informed clinical decisions, while patients depend on clear instructions to use medicines safely and effectively. Providing easy access to approved regulatory information also promotes transparency throughout a medicine's lifecycle. The Medicines and Healthcare products

Marketing Authorisations (MAs) require updates throughout a medicine's lifecycle to reflect changes in manufacturing, quality, safety, efficacy, product information, or administrative details. To ensure that these changes are appropriately assessed and approved while maintaining product quality and patient safety, the Medicines and Healthcare products Regulatory Agency (MHRA) provides detailed guidance on applying for variations to UK Marketing Authorisations. The MHRA guidan

Medicines labelling and packaging are fundamental to the safe and effective use of medicines. Clear packaging enables patients, carers, pharmacists, and healthcare professionals to correctly identify medicines, understand essential safety information, and minimise the risk of medication errors. Poor label design, confusing layouts, or lookalike packaging can contribute to dispensing mistakes and inappropriate medicine use. To promote consistent and patient-focused packaging,

Medicines packaging, labelling, and Patient Information Leaflets (PILs) are essential components of medicine safety and regulatory compliance. They provide healthcare professionals and patients with critical information regarding the safe use, storage, administration, and identification of medicinal products. Throughout a medicine's lifecycle, these materials must remain accurate, up to date, and consistent with the approved product information to support patient safety and r

Determining whether a product qualifies as a medical device is one of the most important regulatory decisions for manufacturers before placing a product on the Great Britain market. Many products fall into a "borderline" category because they may share characteristics with medicines, cosmetics, food supplements, biocides, personal protective equipment (PPE), or other regulated products. To provide greater regulatory clarity, the Medicines and Healthcare products Regulatory Ag

Manufacturers who intend to place medical devices on the market in Great Britain or Northern Ireland must comply with the registration requirements established by the Medicines and Healthcare products Regulatory Agency (MHRA). The Register Medical Devices to Place on the Market guidance explains which devices require registration, who is responsible for registration, applicable timelines, registration procedures, and the associated fees. It also outlines the differences in re

Clinical trials are conducted in accordance with approved protocols and regulatory requirements designed to protect participants and ensure the generation of reliable scientific data. However, changes may become necessary during the course of a study due to emerging safety information, operational considerations, scientific developments, or updates to study procedures. The MHRA guidance Clinical Trials for Medicines: Modifying a Clinical Trial Approval provides a framework fo