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|
|Chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances||EMA/CHMP/QWP/104223/2015||19 January 2016|
|Requirements for selection and justification of starting materials for the manufacture of chemical active substances||Reflection paper||EMA/448443/2014||October 2014|
|Use of cocrystals of active substances in medicinal products||CHMP/CVMP/QWP/284008/2015||Jul 2015||Jun 2015|
|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 declaration concerning GMP compliance of active substance manufacture "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|Active-substance-master-file procedure||Draft guideline||CPMP/QWP/227/02 Rev. 2||Superceded by rev. 3|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||Draft guideline||EMA/CHMP/QWP/96664/2015||24 April 2015||Deadline for comments 24 October 2015|
|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.
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