Regulatory Blog

The guidance Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle  was issued on 30 March 2026 , updating and superseding the earlier 2016 guidance, and providing comprehensive recommendations on how patient preferences can inform benefit-risk assessments. The FDA recognizes that patients living with diseases or conditions develop first-hand insights into treatment benefits and risks. Their perspectives can play a critical role in evaluatin

The guidance Guide to manufacturers and notified bodies on the procedure for requesting advice from expert panels for orphan medical devices  was published on 31 March 2026 , outlining the procedural framework and expectations for applicants seeking scientific and regulatory advice. Orphan medical devices are those intended for the diagnosis, prevention, or treatment of rare conditions, where limited patient populations create challenges in generating extensive clinical evi

The UK regulatory landscape for medicines is increasingly evolving to integrate environmental protection alongside public health safety, and recently, on 1 April 2026, the UK MHRA updated its guidance on " Environmental Risk Assessments in medicines " . A key component of this approach is the requirement for Environmental Risk Assessments (ERA), ensuring that medicinal products do not pose unintended risks to ecosystems during their lifecycle. Background Environmental Risk

The U.S. Food and Drug Administration (FDA) has issued updated guidance in 2026 to help drug manufacturers effectively respond to FDA Form 483 observations issued at the conclusion of CGMP inspections. This guidance focuses on improving communication, investigation quality, and corrective actions, ensuring that manufacturers address compliance gaps while protecting patient safety and product quality. Scope and Purpose This guidance applies to both domestic and international d

The European Medicines Agency (EMA) has introduced two significant guidance updates in 2026, focusing on active substance chemistry requirements  and the emerging use of additive manufacturing (3D printing) in pharmaceuticals . These updates aim to strengthen quality, control strategies, and innovation , while ensuring that pharmaceutical development and manufacturing remain scientifically robust and patient-focused. Guidance: Chemistry of Active Substances Scope and Regulato

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

India’s Central Drugs Standard Control Organization (CDSCO) has released a draft notification dated 09 March 2026  proposing amendments to the Drugs Rules, 1945 to establish a structured framework for managing post-approval manufacturing changes. This draft notification introduces clear regulatory requirements for notifying authorities when manufacturers make changes to manufacturing processes, excipients, packaging, shelf life, specifications, testing procedures, or docume

Introduction The Therapeutic Goods Administration (TGA) released multiple New & updated guidance s on 16 March 2026 , that provides clarity on when certain software products may be excluded from medical device regulatory requirements . With the rapid growth of digital health technologies, this guidance helps distinguish between software that requires regulation and software that can be safely excluded based on its intended use and risk profile. Background As digital health s

This guidance , " Guidance on Controlled Substances Company Meetings " , issued by Swissmedic and valid from 06 March 2026, outlines the framework for Controlled Substances Company Meetings. These meetings are designed to support companies handling controlled substances or involved in the cultivation of cannabis for medical purposes, enabling efficient interaction with Swissmedic’s Narcotics Division. Background Companies dealing with controlled substances must comply with st

This guidance , published in March 2026 by the European Directorate for the Quality of Medicines & HealthCare (EDQM) , introduces new approaches for accelerating the assessment of Certificates of Suitability (CEP) applications. It focuses on two key pathways: Fast-track assessment Reliance-based assessment Both approaches aim to improve regulatory efficiency, reduce delays, and ensure timely access to medicines. CEP procedures are essential for demonstrating that a substance

Introduction This guidance, "General Considerations for the Use of New Approach Methodologies in Drug Development" , published as a draft in March 2026 , provides a framework for using New Approach Methodologies (NAMs)  in drug development. NAMs include approaches such as: In vitro models (simple and complex systems) In chemico methods In silico modelling The goal of this guidance is to improve human-relevant toxicology prediction  and reduce reliance on animal testing. Backg

Introduction This guidance, "Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs ", published in March 2026 , provides detailed recommendations for applicants submitting Abbreviated New Drug Applications (ANDAs)  for topical drug products. It focuses on physicochemical and structural (Q3) characterization, which plays a critical role in demonstrating product performance and bioequivalence (BE). Topical products, especially semisoli

This guidance, " Submitting an application for review by the ACBS, "  explains how to submit an application to the Advisory Committee on Borderline Substances (ACBS) . The ACBS evaluates products that may be considered borderline between foods and medicines, particularly for use within the NHS. The guidance provides a structured approach to ensure that applications are complete, accurate, and suitable for review. Purpose of the Application Process The purpose of this  guidanc

This guidance, " Archiving and retention of clinical trial records, "  explains the requirements for archiving and retaining clinical trial records. Proper archiving is essential to ensure that trial data remains accessible, accurate, and verifiable  over time. It supports regulatory compliance and ensures that clinical trials can be reviewed, inspected, or audited when required. Purpose of Archiving and Retention The purpose of this guidance  is to ensure that essential cli

This guidance , " Clinical Trials Regulations enforcement provisions , "  explains how regulatory authorities enforce compliance in clinical trials. Its primary focus is to ensure that trials are conducted in a way that protects participant safety, rights, and data integrity. It supports the implementation of the Medicines for Human Use (Clinical Trials) Regulations, ensuring that all trials meet required legal and ethical standards. Purpose of Enforcement Provisions The purp

Medical devices intended for weight management play an important role in addressing obesity and related health conditions. The U.S. Food and Drug Administration (FDA) has issued guidance to help manufacturers understand regulatory expectations when developing and submitting premarket applications for medical devices with indications associated with weight loss. The FDA guidance titled “ Medical Devices with Indications Associated with Weight Loss: Premarket Considerations ”  

The development of biosimilar and interchangeable biological products is an important part of improving access to biological medicines. To support this process, the U.S. Food and Drug Administration (FDA) has issued guidance documents that clarify regulatory expectations under the Biologics Price Competition and Innovation Act (BPCI Act) . Two key FDA guidance documents provide detailed explanations through a question-and-answer format  to help sponsors understand the regulat

Regulatory authorities across the European Union continue to strengthen pharmacovigilance systems and data-driven regulatory decision-making. Two important EMA documents highlight these developments: the EU implementation strategy for the ICH E2D(R1) guideline on post-approval safety data  and the Network Data Steering Group (NDSG) Workplan 2026–2028 on data and artificial intelligence in medicines regulation. Guidance: Network Data Steering Group Workplan 2026–2028: Data and

If you're developing a medical device or in vitro diagnostic (IVD) and need clarity on UK regulatory requirements, the MHRA offers a dedicated paid advisory meeting service. This guidance, " Medical devices: get regulatory advice from the MHRA " is particularly useful when the application of existing regulations to your specific device or situation isn't straightforward. Here's a full breakdown of how the service works. What it's for The service is designed to provide regulat

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,