Regulatory Blog

In February 2026, the U.S. Food and Drug Administration (FDA) issued a draft guidance for industry outlining considerations for using a Plausible Mechanism Framework  to develop individualized therapies that target specific genetic conditions with a known biological cause. The draft guidance, developed by the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER), describes how developers may generate substantial evidence o

The UK medicines regulatory framework provides structured pathways for obtaining a licence to market a medicinal product. Two key guidance documents outline the National Assessment Procedure (NAP)  and the process to Apply for a licence to market a medicine in the UK . Together, these resources explain how applicants can submit, manage, and progress marketing authorisation applications within the UK regulatory system. Guidance: National Assessment Procedure (NAP) for Medicin

Reclassification of medicines is an important regulatory mechanism that allows changes to the legal supply status of a medicinal product in the United Kingdom. The UK guidance on reclassification explains how applicants can apply to change the classification of a medicine, outlines procedural pathways, and clarifies the regulatory expectations associated with such changes. Using the Reclassification Guidance The guidance is intended for marketing authorisation holders or app