- Home
- Regulatory
- Human medicines
- Scientific guidelines
- Quality
- Active Substance
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/CHMP/CVMP/QWP/696270/2010 | Released for consultation December 2010 | Deadline for comments postponed to 30 September 2011 | ||
| Active substance-master-file procedure | CHMP/QWP/227/02 Rev. 3 | 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| Active-substance-master-file procedure | Draft guideline | CPMP/QWP/227/02 Rev. 2 | Superceded by rev. 3 | ||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 | |
| Summary of requirements for active substances in the quality part of the dossier | CHMP/QWP/297/97 Rev. 1 | June 2004 | February 2005 | ||
| Chemistry of new active substances | Adopted guideline | CPMP/QWP/130/96 Rev. 1 | December 2003 | February 2004 | |
| 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
How useful is this page?
Average rating:
Based on 65 ratingsAdd your rating:
- See all ratings
-
6 ratings1 ratings3 ratings12 ratings43 ratings