Regulatory Blog

Introduction This guidance, "General Considerations for the Use of New Approach Methodologies in Drug Development" , published as a draft in March 2026 , provides a framework for using New Approach Methodologies (NAMs)  in drug development. NAMs include approaches such as: In vitro models (simple and complex systems) In chemico methods In silico modelling The goal of this guidance is to improve human-relevant toxicology prediction  and reduce reliance on animal testing. Backg

Introduction This guidance, "Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs ", published in March 2026 , provides detailed recommendations for applicants submitting Abbreviated New Drug Applications (ANDAs)  for topical drug products. It focuses on physicochemical and structural (Q3) characterization, which plays a critical role in demonstrating product performance and bioequivalence (BE). Topical products, especially semisoli

This guidance, " Submitting an application for review by the ACBS, "  explains how to submit an application to the Advisory Committee on Borderline Substances (ACBS) . The ACBS evaluates products that may be considered borderline between foods and medicines, particularly for use within the NHS. The guidance provides a structured approach to ensure that applications are complete, accurate, and suitable for review. Purpose of the Application Process The purpose of this  guidanc