The new Technical Guide for the elaboration of monographs on medicinal products containing chemically defined active substances (2020) was approved by the European Pharmacopoeia (Ph. Eur.) Commission at its 168th session in November 2020.
This document provides clear guidance for those involved in drafting medicinal product monographs and is also a means of communicating the principles for the elaboration of monographs to users of the Ph. Eur.
A monograph on a medicinal product is drafted with the same overall structure as a monograph on a chemically defined substance and the latest versions of both the Technical guide for the elaboration of monographs (2015) and the Style guide of the European Pharmacopoeia (2017) apply.
This new guide develops the specific points that are relevant to medicinal products containing chemically defined active substances and which are not presented in the above-mentioned overarching guides. In particular, it includes a section on the Ph. Eur.’s newly agreed dissolution and disintegration testing policy for medicinal products that was also adopted at the 168th session and will be published in the revised Ph. Eur. General notices in Supplement 10.6.