GMP News No. 462
9 September 2004
EU: Quality of Drug
Substance in the Dossier
The revised Note for Guidance on the European Drug Master File Procedure was adopted by CPMP/CVMP in January/February 2004 and came into operation on 31 August this year. What's new compared to the drafted guideline, we commented about on 23 August 2002.
Quality of Drug Substance in the dossier for an application of a marketing authorisation
Since 01 July 2003 the harmonised format of the CTD (Common Technical Document) is mandatory in the EU for all types of marketing authorisations irrespective of procedure (national, Mutual Recognition Procedure or centralised) or whether they are based on a full or abridged applicaton.
The CTD is an internationally agreed upon format for the preparation of a presentation for applications to be submitted to the regulatory authorities.
The CTD is organized into 5 modules. Chemical, pharmaceutical and biological documentation is provided by Module 3, the 'Quality Part' that is subdivided into the drug substance ('S') and the drug product ('P') part.
According to the revised Guideline on Summary of Requirements for
Active Substances in the Quality Part of the Dossier (CHMP/QWP/297/97
Rev 1 corr - EMEA/CVMP/1069/02) that will be coming into operation on 01
February 2005, there are 4 feasible ways to submit the required
information for the drug substance:
Details about the CEP procedures are laid down in Resolution AP-CSP (99) 4. The revised Guideline on Active Substance Master File Procedure (EMEA/CVMP/134/02 - CPMP/QWP/227/02) that is coming into operation on 31 August this year is intended to help applicants for human and veterinary medicinal products, when using the European Drug Master File (EDMF) procedure for active substances in the preparation of a dossier for an application to a marketing authorisation.
Adopted Note for Guidance on the European Drug Master File Procedure
The draft revision of the NfG on the European Drug Master File Procedure (EMEA/CVMP/134-02-CPMP/QWP/227/02-Consultation, February 2002) proposed to make the CEP procedure mandatory for those existing active substances described in the European Pharmacopoeia. This proposal was not agreed upon in the adopted version, where the EDMF procedures can still be used for all active substances, i.e.:
Additionally, the adopted version clarifies the cases where the EDMF
holder may have an EDMF as well as a CEP for a single substance: "(
Generally, it is however not acceptable that the Applicant/MA holder
refers to an EDMF as well as to a CEP for a single active substance of a
particular MAA. In cases where the CEP contains too little information
(e.g. stability) the Competent Authorities/EMEA may decide that additional
information should be provided in the dossier. In such case it may be
acceptable to refer both to an EDMF and a CEP (
Recommendation for an ECA Education Course
If you wish detailed information about the different ways to submit the required information for the drug substance and how to fulfil the requirements, we recommend to attend in the ECA Education Course 'CTD, CEP and DMF Quality of Drug Substance' that will be held from 11 12 November 2004 in Barcelona Spain. Please click here for further information.