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.
Final Guideline on Active Substance Master File Procedure – Revision 4 (PDF/358.28 KB)
First published: 14/12/2018
Legal effective date: 17/06/2019
CHMP/QWP/227/02 Rev 4, EMEA/CVMP/134/02 Rev 4 Corr.
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Electronic Active Substance Master Files (eASMF) |
ASMF Holders who are supplying substances to more than one Centrally Authorised Product (CAP) should submit their ASMF to the Agency once and not for each application.
The use of eCTD is mandatory for all for centralised procedure human ASMF submissions since 1 July 2016. The use of eCTD is mandatory for ASMFs used for DCP/MRP human procedures from 1 January 2018. Use of eCTD is mandatory for new national MAAs since 1 July 2018 and from 1 January 2019 for all other submission types. The relevant guidance should be followed and the technical eCTD validation criteria must be passed.
To ensure that the above is followed promptly, please refer to the human EMA Pre-authorisation guidance carefully and apply for an EMEA/ASMF/XXXXX number at your earliest convenience by submitting the EMEA/ASMF request form.
For veterinary medicines the accepted electronic format is VNeeS and NeeS and for ASMFs also exceptionally eCTD is allowed. More information can be found from the Veterinary Pre-submission guidance.
Please take a note of the voluntary EU ASMF Assessment worksharing. A different EU/ASMF request form should be submitted when requesting participation in the EU worksharing procedure.
It is very important to note that the above two initiatives are different.
- The EMA eASMF submission rules are mandatory since 1st September 2013 and are applicable to all Centralised applications.
- The EU Assessment worksharing initiative is valid for Centralised and Decentralised procedures.
A valid ASMF should have either an EMEA/ASMF number or an EU/ASMF number, depending on the intended use of the ASMF by its holder. When applying for EMEA or EU ASMF numbers, or submitting any documentation quoting these, please note that they are not inter-changeable. Only one ASMF number should be quoted.
It is mandatory to use XML delivery files for ASMF submissions using the eSubmission Gateway and the Web Client.
Related Documents
- EU Harmonised Technical Guidance for ASMF Submissions in eCTD format version 2.3(01.07.2020)Updated
- EMA Pre-authorisation guidance
- EMEA/ASMF number request template request form
- EU/ASMF number request template request form
- Letter of Access Template (Previously Annex 2), Template Administrative Information – (Previously Annex 3), Template Withdrawal of Access Letter –Should be filled in in accordance of the ASMF type (EU/ASMF/XXXXX or EMEA/ASMF/XXXXX)
- EU ASMF Assessment Worksharing
- Active Substance Master File Procedure Guidance – Human
- Active Substance Master File Guidance – Veterinary
- Example of ASMF in eCTD format
ACTIVE SUBSTANCE MASTER FILE (ASMF)
Training presentations on Active Substance Master File (ASMF) work sharing procedure:
- ASMF worksharing – Introduction to the procedure (October 2018)
- Requesting an EU_ASMF repository number (October 2018)
- Submitting an initial worksharing ASMF (October 2018)
- Determining the parent procedure (October 2018)
- Assessment report template (October 2018)
- Sharing assessment reports (October 2018)
- Submitting a variation to an ASMF (October 2018)
- Use of an approved ASMF in a new procedure (October 2018)
An Active Substance Master File (ASMF), or formerly known as European Drug Master File (EDMF) procedure, is a set of documents that protects the valuable confidential intellectual property of the manufacturer. The purpose of an ASMF is to provide the Health Authorities (HAs) with complete information of the active substance used in a drug product to evaluate its suitability for the product. It also allows the Marketing Authorization Holder (MAH) of the product to take the responsibility for the quality of the active substance used in the product.
ASMF Content
An ASMF must contain all the scientific information related to the active substance. The information of an ASMF is divided into two parts:
- Applicant Part (AP) – Contains information considered as non-confidential by the MAH
- Restricted Part – Contains confidential information
ASMF Usage
An ASMF is submitted only to support a Marketing Authorisation Application (MAA) or Marketing Authorisation Variation (MAV). It is used for the following active substances:
- Active substances that are new
- Already existing active substances, which are excluded from the European Pharmacopoeia (Ph. Eur.)
- Pharmacopoeial active substances, which are included in the (Ph. Eur.)
An ASMF holder is required to submit the following to the MAH holder:
- A copy of AP’s latest version
- A copy of the summary/detailed version of AP’s latest version
- A copy of the letter of access, which has not been previously submitted for the same product
A single active substance can have both, an ASMF as well as a Certificate of Suitability (CEP). However, the MAH cannot refer to both the documents for a single active substance. In case, the information present in a CEP is insufficient, only then both the documents can be referred.
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