EMA Guideline on Chemistry of Active Substances

Date

March 26, 2026

Category

EU Regulations

Description

A revision to the 2016 version of the guideline on the chemistry of active substances was published on 20 March 2026 and is effective from 1 September 2026.  See Chemistry of active substances (chemistry of new active substances) - Scientific guideline | European Medicines Agency (EMA)

This revision includes further recommendations on cohort of concern impurities, principally N-nitrosamines, and expands the sections covering starting materials, recovery and re-processing.