Quality: Active substance

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This page lists the European Medicines Agency's guidelines on the quality aspects of active substances.

If you have comments on a document which is open for consultation, use the form for submission of comments on scientific guidelines.

TopicDocumentsReference numberPublication dateEffective dateRemarks
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological / biological entities)

Adopted guideline

Draft guideline

CHMP/ICH/425213/2011May 2012 November 2012 
Template for the qualified person’s (QP's) declaration concerning good-manufacturing-practice compliance of the active substance used as starting material and verification of its supply chain "the QP declaration template"

Template guidance


Draft template

Draft questions and answers

EMA/334808/2014  June 2014 
Active substance-master-file procedure

Adopted guideline

Template (annexes

Overview of comments

Draft guideline

CHMP/QWP/227/02 Rev. 3 CorrJuly 2012 October 2012Additional guidance on documents relating to an active substance master file (02/10/2012)
Active-substance-master-file procedureDraft guidelineCPMP/QWP/227/02 Rev. 2  Superceded by rev. 3
Active-substance-master-file procedureAdopted guidelineCPMP/QWP/227/02 Rev. 1April 2005August 2004 
Recommendation on the assessment of the quality of medicinal products containing existing/ known active substancesDocument of interestCHMP/CVMP/QWP/450653/2006Feb 2009  
Summary of requirements for active substances in the quality part of the dossier

Adopted guideline

Draft guideline

CHMP/QWP/297/97 Rev. 1June 2004February 2005 
Concept paper on the need for a single note for guidance on the chemistry of active substances

Concept paper

Adopted guideline

EMA/CHMP/QWP/752676/2013Released for consultation 10 February 2014 Deadline for comments 10 August 2014
Investigation of chiral active substancesAdopted guideline3CC29AOctober 1993April 1994 
Chemistry of active substancesAdopted guideline3AQ5A October 1987 

Additional guidance is available under Heads of Medicines Agencies: Active Substance Master File Working Group.

More guidance is available under question no.24 of pre-submission guidance.