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:
2.1 Certificate of Suitability to the Monograph of the European
Pharmacopoeia
(CEP)
2.2 Active Substance Master File (ASMF) Procedure
2.3 Full details of manufacture
2.4 Other supportive data in consideration of the qualification of
impurities
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.:
- New active substances
- Existing active substances not included in the European
Pharmacopoeia (Ph.Eur.) or the pharmacopoeia of an EU Member State
- Pharmacopoeial active substances included in the Ph.Eur. or in the
pharmacopoeia of an EU Member State
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 (…)"
