Regulatory Blog

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