EMA/CHMP has published the new draft revision of the “Guideline on the chemistry of active substances”

The updated guideline will replace the “Note for guidance on chemistry of new active substances – (CPMP/QWP/130/96, Rev 1)” and the “Chemistry of active substances – (3AQ5a)”, it has been revised to cover new and existing active substances in one guideline.

As reported, the Concept paper on the revision of the guideline on the chemistry of active substances” of the Quality Working Party (QWP) was published for comments in June 2022. This document aimed to explain and clarify the need to revise and update the “Guideline on the chemistry of active substances (EMA/454576/2016)” and to outline the procedure for the revision.

The results obtained and insights gained were incorporated into the draft of revision 1 of the “Guideline on the chemistry of active substances,” which was published in July 2024. The draft is now open for public comments until the end of January 2025.

As already contemplated in the concept paper, the topic of N-nitrosamine was considered and integrated throughout the text of the guideline

SOURCES:

https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-chemistry-active-substances-revision-1_en.pdf