Regulatory Blog

The U.S. Food and Drug Administration (FDA) continues to modernize clinical research and postmarketing safety monitoring through new guidance documents focused on digital health technologies and real-world safety evidence. In May 2026, FDA published two important guidance documents: Submitting Continuous Glucose Monitoring Data in Clinical Trials Postapproval Pregnancy Safety Studies Guidance on Continuous Glucose Monitoring (CGM) Data in Clinical Trials What is Continuous Gl

The integrity, reliability, and robustness of clinical trial data are fundamental to regulatory decision-making, particularly for marketing authorisation applications (MAAs). With the increasing reliance on computerised systems such as electronic case report forms (eCRFs), electronic patient-reported outcomes (ePROs), safety databases, interactive response technologies (eIRT), and clinical trial management systems (CTMS), the role of validated digital systems has become centr

The guidance Clinical trials for medicines: Roles and responsibilities provides a comprehensive framework that outlines how responsibilities are distributed among stakeholders involved in clinical trials in the United Kingdom. Introduction Clinical trials in the UK are governed by a structured system where responsibilities are clearly defined to ensure participant safety, ethical conduct, and reliable data generation. This guidance outlines the roles of key stakeholders, inc

The UK regulatory landscape for clinical trials is undergoing a significant transformation with the implementation of updated Medicines for Human Use (Clinical Trials) Regulations, effective from 28 April 2026. These changes emphasize quality by design, risk-based approaches, and strengthened manufacturing standards, ensuring both participant safety and data integrity. Guidance: Clinical trials for medicines: Guidance on Quality and Risk Proportionality Scope This guidance ap

Clinical trials play a critical role in evaluating the safety and effectiveness of medicines before they are made available to patients. In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) provides guidance to help sponsors and researchers comply with regulatory requirements for clinical trials involving medicinal products. This article provides a consolidated overview of MHRA guidance covering several key areas of clinical trial regulation,

Clinical trials are the foundation for understanding whether a medical product is safe and effective. However, for many years, clinical trial populations have not fully reflected the patients who ultimately use these products in real-world settings. To address this gap, the U.S. Food and Drug Administration (FDA) has issued two complementary guidance documents: Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs (Decembe

The European Medicines Agency (EMA) has released a major draft guideline " Non-Inferiority and Equivalence Comparisons in Clinical Trials " that updates how non-inferiority and equivalence comparisons should be designed, justified, and analysed in confirmatory clinical trials. This draft replaces two earlier documents: Guideline on the choice of the non-inferiority margin (2005), and Points to consider on switching between superiority and non-inferiority (2000). The new gu

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

On 25 September 2025 , the U.S. Food and Drug Administration (FDA) highlighted four critical updated or reaffirmed guidances spanning...

On 18th August 2025, the U.S. Food and Drug Administration (FDA) recently published two important draft guidance documents that aim to...

In May 2025, the FDA, as part of the International Council for Harmonisation (ICH), endorsed and released for consultation the draft E21...

Before starting any clinical investigation involving a medical device in the UK, it is a legal requirement to notify the Medicines and...

Today (26 May 2023) the United States Food & Drug Administration released multiple guidances related to both drugs/biologics and medical...

Last Week (03 May 2023) the European Medicines Agency released an Interim guidance document on "How to Approach the Protection of...

Recently (9 March 2023) the European Medicine agency released a "Guideline on Computerised Systems & Electronic Data in Clinical Trials"...

Yesterday (26-December-2022) the South African Health Products Regulatory Authority (SAPHRA) released an updated "Requirements for...

Earlier today USFDA's Center for Drug Evaluation and Research (CDER) & Oncology Center of Excellence released the updated final guidance...

Earlier on 21 October 2022, the USFDA released two finalized guidances "Multiple Endpoints in Clinical Trials" and "Human Gene Therapy...

On 2 June, an official Q&A prepared by the European Commission (EC), European Medicines Agency (EMA), and the Heads of Medicines Agencies...

On 3-February, 2022 Ireland adopted a new guideline the "EU Clinical Trial Regulation" (Regulation No 536/2014, hereafter ‘CTR’), was...