Regulatory Blog

The US Food and Drug Administration (FDA) has announced its Fiscal Year (FY) 2027 Generic Drug User Fee Amendments (GDUFA) Science and Research Priority Initiatives. The guidance outlines eight research areas intended to address scientific challenges in generic drug development, improve the efficiency of bioequivalence assessments, and accelerate patient access to generic medicines. The priorities were identified through collaboration with industry and public stakeholders, in

The US Food and Drug Administration (FDA) has issued Regulatory Considerations for Prescription Drug Use-Related Software, a guidance for industry addressing the application of drug labeling requirements to software developed or distributed by, or on behalf of, prescription drug sponsors. The guidance explains how FDA considers software-generated content presented to patients, caregivers, and healthcare professionals, and how this content should be addressed in prescription d

The US Food and Drug Administration (FDA) revised its Small Entity Compliance Guide: Safety Reporting Requirements for INDs and BA/BE Studies in October 2026. The guidance helps small businesses understand safety reporting requirements for investigational drugs and biological products under Investigational New Drug (IND) applications and bioavailability (BA) and bioequivalence (BE) studies exempt from IND requirements. The revision updates the history of related guidance docu

The US Food and Drug Administration (FDA) has issued two compliance policy guidances addressing requirements for blood establishments that collect blood and blood components, including Source Plasma. The guidance on Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements and the guidance on Blood Pressure and Pulse Donor Eligibility Requirements describe circumstances where FDA does not intend to take regulatory action

The European Medicines Agency (EMA) has published guidance explaining how changes to the scope of Paediatric Investigation Plan (PIP) Decisions should be managed when a medicine’s development plans or regulatory submission strategy changes. The policy addresses situations where existing PIP Decisions no longer match the scope of a planned regulatory application and explains when PIP Decisions may need to be linked, modified or reduced in scope. The policy aims to ensure that

The Medicines and Healthcare products Regulatory Agency (MHRA) guides registering medical devices for placement on the Great Britain and Northern Ireland markets. The guidance covers the registration process, placing devices on the market, putting devices into service, importers, in vitro diagnostic devices (IVDs), fees, registration updates, and specific transitional arrangements for devices with expired or expiring CE certificates. Registration for the Great Britain Market

The US Food and Drug Administration (FDA) has published two important guidance documents addressing the development, approval and lifecycle management of biosimilar and interchangeable biosimilar products. The Questions and Answers on Biosimilar Development and the BPCI Act, Revision 4, and Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers were issued in October 2026. Together, these guidance documents provide reco

The US Food and Drug Administration (FDA) has published updated technical guidance documents addressing standardized electronic study data submissions and the electronic transmission of Individual Case Safety Reports (ICSRs). The Study Data Technical Conformance Guide – Technical Specifications Document and the E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide provide technical recommendations to support consistent data structures, electro

The European Medicines Agency (EMA) has published two important regulatory documents addressing pharmaceutical equivalence and pharmacogenomic practices. The draft Guideline on the requirements for demonstrating therapeutic equivalence for nasal products outlines the evidence needed to demonstrate equivalence between nasal medicines. The Concept paper on the guideline revision on good pharmacogenomic practice describes proposed updates to pharmacogenomic methodology, genetic

The World Health Organization (WHO) has issued a draft working document, QAS/26.994, titled WHO Guidelines on Quality Risk Management, dated September 2026. The draft provides recommendations for implementing quality risk management (QRM) throughout the pharmaceutical product lifecycle, covering development, manufacturing, quality control, distribution, and regulatory oversight. The proposed guidance focuses on science-based decision-making, risk assessment and control, docum

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has provided guidance on applying for a licence to market a medicine in the UK and on using electronic Application Forms (eAFs) for medicines licensing applications. The first guidance explains the marketing authorisation application process, including electronic submissions, supporting documentation, product naming, fast-tracking, rejection, and fees. The second explains how applicants can download, complete,

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published two guidance documents covering important aspects of medicines regulatory lifecycle management: variations to marketing authorisations and renewal of marketing authorisations. The first explains how marketing authorisation holders can submit changes to authorised medicines, including minor variations, major variations, and extensions. The second outlines renewal requirements for products authorise

The U.S. Food and Drug Administration (FDA), Health Canada, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have jointly identified 10 guiding principles for Good Machine Learning Practice (GMLP) in medical device development. These principles aim to support the development of safe, effective, and high-quality medical devices that use artificial intelligence and machine learning (AI/ML). They address the unique challenges associated with data-driven de

The FDA has issued two draft guidances in September 2026 covering important aspects of medical device regulatory submissions. One focuses on premarket submissions for robotically-assisted surgical devices (RASDs), while the other provides recommendations for the electronic submission of Premarket Approval (PMA) applications using the eSTAR template. These guidances highlight FDA's focus on structured technical evidence, software and cybersecurity considerations, clinical and

ICH M13B Guideline: Additional Strengths Biowaiver for Immediate-Release Solid Oral Dosage Forms The European Medicines Agency (EMA) has adopted the ICH M13B Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms – Additional Strengths Biowaiver, together with a related Questions and Answers (Q&A) document. The guideline provides recommendations for obtaining a biowaiver for one or more additional strengths when in vivo pharmacokinetic bioequivalence or eff

The European Medicines Agency (EMA) has published two complementary guidance documents explaining the new CTIS Safety Module for Annual Safety Reports (ASRs). Together, they describe the end-to-end process for ASR submission, assessment, safety issue management and finalisation. Sponsor Guidance: New Safety Module on the Annual Safety Report The Sponsor Guidance explains how sponsors will prepare, submit and manage Annual Safety Reports through the new Safety Module. Transiti

The National Assessment Procedure for Medicines provides a framework for UK-wide marketing authorisation applications assessed through the national procedure. It covers applications for innovative and established medicines, including submission requirements, assessment stages, timelines, requests for information, Commission on Human Medicines involvement, and regulatory decisions. Introduction The national assessment procedure applies to UK-wide marketing authorisation applic

Marketing authorisation variations allow changes to an authorised medicine, including administrative changes, changes affecting product quality, and changes that may affect safety, efficacy or pharmacovigilance requirements. The Medicines: apply for a variation to your marketing authorisation guidance explains the UK procedures for Type IA, Type IB and Type II variations, extensions, grouping and bulk submissions, product information changes, fees and application requirements

Advanced therapy medicinal products (ATMPs) are regulated medicinal products that include gene therapy medicinal products, somatic cell therapy medicinal products, and tissue-engineered products. The Advanced Therapy Medicinal Products: Regulation and Licensing in the UK guidance explains the regulatory and licensing arrangements for ATMPs in the UK, including product classification, regulatory advice, clinical trials, marketing authorisation, combination ATMPs, manufacturing

The Therapeutic Goods Administration (TGA) has updated its eCTD AU Module 1 and Regional Information v3.2 guidance. A 4 September 2026 update introduced minor editorial changes and added links to the TGA page Dossier requirements for non-prescription medicines and the new user guide Submitting data in electronic Common Technical Document (eCTD) format for a non-prescription medicine application. Dossier requirements for non-prescription medicines: Submitting data in eCTD form