Regulatory Blog

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 , " 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

The U.S. Food and Drug Administration (FDA) has issued guidance documents to help pharmaceutical manufacturers understand regulatory expectations related to market exclusivity for drug products  and responses to inspection findings following CGMP inspections . These guidances support transparency in regulatory processes and help industry ensure compliance with quality and development requirements. Guidance: New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug

This blog summarizes two important regulatory guidances from the U.S. Food and Drug Administration (FDA) that support pharmacovigilance and real-world evidence generation: M14: General Principles for Planning, Designing, Analyzing, and Reporting Non-Interventional Studies E2D(R1): Post-approval Safety Data – Definitions and Standards for Management and Reporting of Individual Case Safety Reports Together, these guidances provide a framework for how pharmaceutical companies ge

The Medicines and Healthcare products Regulatory Agency (MHRA) provides an online portal that enables organisations and individuals to submit regulatory forms and manage applications electronically. The MHRA Portal is designed to streamline regulatory submissions, improve efficiency, and provide a centralised system for interacting with the agency. This guidance explains how users can register for the MHRA Portal, outlines the registration process, and describes key considera

The Early Access to Medicines Scheme (EAMS)  is a regulatory initiative in the United Kingdom designed to provide patients with life-threatening or seriously debilitating conditions earlier access to promising medicines before full marketing authorisation is granted. The scheme is administered by the Medicines and Healthcare products Regulatory Agency (MHRA) and aims to accelerate patient access to innovative treatments where there is a clear unmet medical need. The main obj

In February 2026, the U.S. Food and Drug Administration (FDA) issued a draft guidance for industry outlining considerations for using a Plausible Mechanism Framework  to develop individualized therapies that target specific genetic conditions with a known biological cause. The draft guidance, developed by the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER), describes how developers may generate substantial evidence o