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

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