Regulatory Blog

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

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

Good clinical practice (GCP) is an ethical and scientific quality guideline concerning the design, conduct, analysis and reporting of clinical trials of medicines. The Clinical trials for medicines: Good clinical practice inspections guidance provides information on GCP compliance, inspection processes, inspection findings, corrective actions and post-inspection activities. Compliance with Good Clinical Practice Organisations involved in clinical trials are required to comply

Effective pharmacovigilance is essential for protecting patients and supporting the safe and effective use of medicinal products. The Guidelines on Good Pharmacovigilance Practices (GVP) provide a framework for pharmacovigilance activities in the European Union. The latest introductory cover note announces the publication of Revision 2 of Module III on Pharmacovigilance Inspections, reflecting recent changes to the applicable European pharmacovigilance legislation. Background

Accurate and structured medicinal product information is an important part of the regulatory and pharmacovigilance framework. Chapter 3.II: XEVPRM Detailed User Guidance provides detailed instructions for marketing authorisation holders (MAHs) on the electronic submission of information on medicinal products for human use to the European Medicines Agency through the XEVMPD. What is XEVPRM? XEVPRM stands for eXtended EudraVigilance Medicinal Product Report Message. It is the m

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

Swissmedic has issued two guidance documents that provide important regulatory requirements for companies holding medicinal-product authorisations or establishment licences in Switzerland. One guidance covers renewal, discontinuation, and changes between the main authorisation and the export licence, while the other describes the process for Scientific GMDP Meetings with Swissmedic. Together, these guidances provide a structured framework for managing authorisation-related ac

The U.S. Food and Drug Administration (FDA) has issued the September 2026 draft guidance “Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling”. The guidance provides recommendations for sponsors and applicants planning studies to evaluate how hepatic impairment affects the pharmacokinetics (PK) and, where appropriate, pharmacodynamics (PD) of drugs, including therapeutic biological products. It is a draft

Preparing a marketing authorisation application (MAA) requires a sufficiently complete and mature dossier before submission. The European Medicines Agency (EMA) has developed the EU Submission, Timelines and Review Talk (EUSTART) to help applicants, rapporteurs, national competent authority (NCA) assessment teams, and EMA identify important issues before an application is submitted. EUSTART supports preparation for the joint pre-submission meeting (PSM), with the aim of facil

Preparing a marketing authorisation application (MAA) requires early planning, clear communication, and a sufficiently mature dossier. To strengthen this process, the European Medicines Agency (EMA) has introduced a revised Guidance on the "Pre-Submission Interactions (PSI) model" as part of a voluntary pilot phase. The revised model aims to encourage earlier and more comprehensive dialogue between applicants, rapporteurs, and EMA. It focuses on improving submission readiness

As medicines move toward electronic formats, accurate and up-to-date product information is increasingly important. The European Medicines Agency (EMA) has issued guidance, "Electronic product information (ePI) submission during centralised procedures," explaining how applicants should submit, create, update, and maintain electronic product information (ePI) for centrally authorised medicinal products. The guidance provides practical instructions for managing ePI through the