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.
|Topic||Documents||Reference number||Publication date||Effective date||Remarks|
|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)||CHMP/ICH/425213/2011||May 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"||EMA/334808/2014||June 2014|
|Active substance-master-file procedure||CHMP/QWP/227/02 Rev. 3 Corr||July 2012||October 2012||Additional guidance on documents relating to an active substance master file (02/10/2012)|
|Active-substance-master-file procedure||Draft guideline||CPMP/QWP/227/02 Rev. 2||Superceded by rev. 3|
|Active-substance-master-file procedure||Adopted guideline||CPMP/QWP/227/02 Rev. 1||April 2005||August 2004|
|Recommendation on the assessment of the quality of medicinal products containing existing/ known active substances||Document of interest||CHMP/CVMP/QWP/450653/2006||Feb 2009|
|Summary of requirements for active substances in the quality part of the dossier||CHMP/QWP/297/97 Rev. 1||June 2004||February 2005|
|Concept paper on the need for a single note for guidance on the chemistry of active substances||EMA/CHMP/QWP/752676/2013||Released for consultation 10 February 2014||Deadline for comments 10 August 2014|
|Investigation of chiral active substances||Adopted guideline||3CC29A||October 1993||April 1994|
|Chemistry of active substances||Adopted guideline||3AQ5A||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.