Regulatory Blog

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 European Medicines Agency (EMA) has issued Revision 4 of the "Explanatory Note to Good Pharmacovigilance Practices (GVP) Module VII – Periodic Safety Update Report" prepared by the Human Medicines Evaluation Division. This revision addresses practical challenges encountered during the PSUR Single Assessment (PSUSA) process, particularly for nationally authorised medicinal products (NAPs), and serves as the basis for the forthcoming update of GVP Module VII. Purpose of the

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 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 traditional clinical trial model has long been associated with delays in data reporting, lengthy timelines, and inefficiencies in decision-making. Recognizing these challenges, the U.S. Food and Drug Administration (FDA) has taken a transformative step toward modernizing clinical research. This press announcement was released on April 28, 2026, marking a significant milestone in the evolution of clinical trials. The FDA introduced major steps to advance the implementation

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

The Philippines Food and Drug Administration (FDA) is advancing its regulatory framework by adopting internationally aligned practices to improve the quality, transparency, and efficiency of pharmaceutical product regulation. The draft circular Adoption and Implementation of Good Registration Management (GRM), Good Review Practice (GRevP), and Good Submission Practice (GSubP) for Pharmaceutical Products introduces a structured and integrated approach to both regulatory submi

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 Medicines Agency (EMA) continues to advance data standardisation and digital transformation in regulatory processes through the implementation of ISO IDMP standards and Product Management Services (PMS). The guidance Process for the electronic submission of medicinal product information – Chapter 3 (Version 3.5, updated 20 April 2026) provides detailed instructions on how medicinal product data should be submitted, managed, and maintained electronically throughou

The European Medicines Agency (EMA) continues to strengthen transparency, data sharing, and international regulatory collaboration through its Clinical Data Publication (CDP) framework. A key development in this area is the introduction of a work-share initiative with Health Canada (HC) under Policy 0070, aimed at improving efficiency while maintaining robust safeguards for sensitive information. The guidance Clinical Data Publication (CDP): Questions and Answers on EMA Polic

The UK clinical trial regulatory framework is undergoing a major transformation with the implementation of updated ICH E6 (R3) Good Clinical Practice (GCP) principles, alongside new guidance on quality, risk proportionality, and clinical investigations. The guidance Clinical trials for medicines: Compliance with ICH E6 Good Clinical Practice (GCP) in the United Kingdom, Clinical trials for medicines: guidance on quality and risk proportionality, and Clinical investigations fo

The FDA continues to strengthen regulatory expectations across both pharmaceutical quality and medical device oversight, with two important draft guidances issued in April 2026. The guidance Establishing Impurity Specifications for Antibiotics (April 2026, Draft) and Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators (April 20, 2026, Draft) provide structured recommendations for industry and regulators. Guidanc

The regulatory landscape for advanced therapies and patient access in the United States continues to evolve, with the FDA issuing updated guidances in April 2026 that address both cutting-edge genome editing safety and patient access to investigational treatments . Together, these guidances highlight the balance between innovation, safety evaluation, and ethical access to therapies across the product lifecycle. The guidance Safety Assessment of Genome Editing in Human Gene

The Guidance on the electronic submission of information on investigational medicinal products for human use in the Extended EudraVigilance medicinal product dictionary (XEVMPD) was updated on 13 April 2026 (Version 1.5) , providing detailed procedural and technical instructions for sponsors submitting clinical trial product data. Introduction This guidance provides consolidated instructions for sponsors on how to electronically submit information on investigational medici

The European regulatory landscape continues to evolve with a strong focus on supporting innovation in rare diseases and ensuring safe, evidence-based development of medicines for children . The European Medicines Agency (EMA) has issued two key procedural guidelines: Procedural advice for orphan medicinal product designation – Guidance for sponsors Procedural advice on paediatric applications – Guidance for applicants together, establish a comprehensive regulatory framewo

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 framework for clinical trials is undergoing a significant transition with the adoption of updated Good Clinical Practice (GCP) standards aligned with international expectations. The Medicines and Healthcare products Regulatory Agency (MHRA) is reinforcing compliance with ICH E6 (R3) to ensure high standards of participant safety, data integrity, and efficient trial conduct. The guidance Clinical trials for medicines: Guidance on compliance with ICH E6 Good

The U.S. regulatory landscape continues to evolve to ensure data reliability and scientific rigor in drug development, particularly in the growing use of biomarkers. As biomarkers become increasingly critical for evaluating drug safety and efficacy, the FDA has issued specific guidance to standardize how bioanalytical methods for these measurements should be validated. The guidance Bioanalytical Method Validation for Biomarkers was published in April 2026 , providing recom