Europe – Guideline on Active Substance Master File Procedure

The main objective of the Active Substance Master File (ASMF) procedure, formerly known as the European Drug Master File (EDMF) procedure, is to allow valuable confidential intellectual property or ‘know-how’ of the manufacturer of the active substance (ASM) to be protected, while at the same time allowing the Applicant or Marketing Authorisation (MA) holder to take full responsibility for the medicinal product and the quality and quality control of the active substance. National Competent Authorities/EMA thus have access to the complete information that is necessary for an evaluation of the suitability of the use of the active substance in the medicinal product.

Scope
This Guideline is intended to assist Applicants/MA holders in the compilation of the active substance section of their dossiers for a Marketing Authorisation Application (MAA) or a Marketing Authorisation Variation (MAV) of a medicinal product. It is also intended to help ASMF holders in the compilation of their ASMFs.

ASMF Procedure and herbal substances/preparations

In accordance with Directive 2001/83/EC as amended, the quality of traditional herbal medicinal products for human use has to be documented in accordance with existing European legislative requirements. These criteria are laid down in the following guidelines (which are applicable for all Human and Veterinary Herbal Medicinal products): ‘Guideline on quality of herbal medicinal products/traditional herbal medicinal products’ (CPMP/QWP/2819/00, EMEA/CVMP/814/00, in their latest revisions) and the ‘Guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/ traditional herbal medicinal products’
(CPMP/QWP/2820/00, EMEA/CVMP/815/00, in their latest revisions).
It should be noted that the principles which are outlined in table 3 of Annex 1 in relation to traditional herbal medicinal products are equally applicable to other herbal medicinal products, both for Human and Veterinary use, which do not follow the simplified registration procedure.
References:
1. ‘Guideline on quality of herbal medicinal products/traditional herbal medicinal products’
(CPMP/QWP/2819/00, EMEA/CVMP/814/00, in their latest revisions);
2. ‘Guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/ traditional herbal medicinal products’ (CPMP/QWP/2820/00, EMEA/CVMP/815/00, in their latest revisions);
3. ‘Guideline on summary of requirements for active substances in the quality part of the dossier’ (CHMP/QWP/297/97, EMEA/CVMP/1069/02, in their latest revisions)…