Regulatory Blog

Two notable guidance documents released in 2026 address distinct but equally important aspects of healthcare regulation. The first, Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities, provides updated recommendations regarding the communication of healthcare economic and clinical information between manufacturers and healthcare decision-makers. The second, Intent to Exempt Certain Unclassified Medical Devices from Premarket Not

As genome editing technologies continue to advance, sponsors are increasingly developing innovative gene therapies targeting rare, serious, and life-threatening diseases. These programs often involve complex manufacturing processes, extensive nonclinical studies, sophisticated analytical testing, and lengthy clinical development timelines. To support more efficient development pathways, the FDA released the draft guidance, Leveraging Prior Knowledge in the Development of Huma

Bioequivalence (BE) plays a critical role in generic drug development by demonstrating that a generic product performs similarly to its reference listed drug (RLD). To support approval of an Abbreviated New Drug Application (ANDA), manufacturers must establish that the proposed generic product delivers a comparable rate and extent of drug absorption under similar conditions of use. The FDA’s updated guidances, Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Su

Human factors engineering focuses on understanding how users interact with medical devices and applying that knowledge to design safer and more effective products. The FDA explains that user interface design can significantly impact patient safety, as user errors may lead to incorrect treatment, delayed therapy, compromised medical care, or patient harm. Manufacturers routinely perform human factors assessments during device development to identify and mitigate use-related ri

In May 2026, the FDA Oncology Center of Excellence (OCE) and Center for Drug Evaluation and Research (CDER) issued the draft guidance Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products. The guidance introduces risk-based approaches for nonclinical safety assessments of certain oncology biologics and conjugated products, aiming to facilitate development while maintaining patient safety. The guidance highlights that data anal

The global regulatory landscape for oncology medicines is increasingly moving toward collaborative review models that enable faster patient access to innovative treatments. One of the most significant initiatives in this area is Project Orbis, a multinational programme that allows concurrent submission and review of promising cancer medicines across several international regulatory authorities. The UK Medicines and Healthcare products Regulatory Agency (MHRA) guidance on Proj

The South African Health Products Regulatory Authority (SAHPRA) has published a new guidance document titled “Guideline for Preparation of a Site Master File (SMF) for Wholesalers of Medical Devices”. The guideline provides requirements for medical device wholesalers preparing a Site Master File (SMF) as part of medical device establishment licence applications in South Africa. The guidance applies to wholesalers of medical devices, including In Vitro Diagnostic medical devic

The Australian Therapeutic Goods Administration (TGA) has updated its guidance on the implementation of the Unique Device Identification (UDI) system for medical devices supplied in Australia. The guidance, Complying with the Unique Device Identification Timeframes for Medical Devices, Version 2.0, published in May 2026, explains the phased UDI compliance timelines, sponsor responsibilities, transitional arrangements, and direct marking obligations for medical devices and IVD

The Health Products Regulatory Authority (HPRA) has released updated guidance documents to strengthen pharmaceutical quality systems, regulatory compliance, and operational oversight across Ireland’s healthcare sector. The updated guidance documents include: Guide to Quality System for General Sale Wholesale Distributors Guide to Pre-submission Scientific and Regulatory Advice for GXP Activities Guide to Managing Changes to Registrations of Active Substance Manufacturers, Imp

The U.S. Food and Drug Administration (FDA) has issued Revision 1 of its guidance titled "Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations" (May 2026), prepared by the Office of Clinical Pharmacology within the Center for Drug Evaluation and Research (CDER). This revision supersedes part of the 2022 guidance on Food-Effect Bioavailability and Fed Bioequivalence Studies and consolidates current FDA thinking on when, why, and how fo

The U.S. Food and Drug Administration (FDA) continues to expand its regulatory focus on safer pain management, opioid risk reduction, addiction treatment innovation, and infectious disease drug development through multiple recent guidance documents. These guidances collectively highlight the FDA’s evolving strategy toward: Reducing opioid dependence Encouraging non-opioid therapies Supporting innovative pain treatments Strengthening benefit-risk assessments Advancing addictio

The International Medical Device Regulators Forum (IMDRF) continues to strengthen global harmonisation of medical device quality management systems (QMS) through updated guidance focused on supplier controls and risk-based oversight. A major development in this area is the draft guidance titled “Guidance on the Control of Products and Services Obtained from Suppliers ”, published by the IMDRF Quality Management Systems Working Group. The IMDRF draft guidance provides detailed

To support industry stakeholders, the UK Medicines and Healthcare products Regulatory Agency (MHRA) offers a dedicated Regulatory Advice Meeting service for medical devices and in vitro diagnostic devices (IVDs). This service helps organisations better understand regulatory expectations, clarify complex requirements, and navigate the UK regulatory system more effectively. The MHRA guidance titled “Medical devices: get regulatory advice from the MHRA” explains how manufacturer

The United Kingdom’s medical device regulatory system has changed significantly following Brexit. Medical device manufacturers that previously relied mainly on European Union regulations must now also understand UK-specific regulatory requirements for placing devices on the Great Britain market and conducting clinical investigations in the UK. To help manufacturers, sponsors, and regulatory professionals understand these expectations, the UK Medicines and Healthcare products

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

Human cellular and gene therapy (CGT) products are transforming modern medicine by offering innovative treatments for serious and life-threatening diseases such as cancer, genetic disorders, and chronic illnesses. However, the development and manufacturing of these therapies are often highly complex due to personalized production processes, advanced technologies, limited patient populations, and short product shelf-lives. To support innovation while maintaining product qualit

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 Singapore Health Sciences Authority (HSA) has released Version 6 of its updated guidance document titled “Post-Marketing Vigilance Requirements for Therapeutic Products and Cell, Tissue and Gene Therapy Products (CTGTP)”, effective from 1 April 2026. The updated guidance provides important clarification on pharmacovigilance obligations, adverse event reporting, risk management plans (RMPs), and post-registration safety responsibilities for companies operating in Singapore

Medicine shortages and discontinuations are a growing global concern, and Australia has established a robust regulatory framework to ensure early detection, transparency, and risk mitigation. The guidance Reporting a shortage or discontinuation of a medicine you supply (updated 13 April 2026) outlines the mandatory obligations for sponsors to report medicine shortages and discontinuations to the Therapeutic Goods Administration (TGA). A medicine shortage occurs when supply is

The European Union continues to strengthen its medical device regulatory framework through updated guidance on device classification, nomenclature (EMDN), and supply chain transparency. These updates aim to improve regulatory clarity, traceability, and patient safety, particularly under the MDR and IVDR frameworks. Key developments include the Update – MDCG 2021-24 Rev.1: Guidance on classification of medical devices (April 2026), alongside supporting guidance documents on EM