What is ASMF ?
ASMF stands for Active Substance Master File, it is also know as European Drug Master file, ASMF Procedure or EDMF Procedure are run in Europe and it allows the manufacture of the active substance (API) to protect its critical confidential information and technical know how and at the same allows the Manufacture of API Substances to take full responsibility of the quality and quality control for active substance.
ASMF is reviewed only with a connection to Marketing Authorization Application (MAA), ASMF supports the MAA with respect to Active substance data . AMSF holder can give LOA to multiple MAA application.
ASMF is submitted directly by Active Substance manufacturer to National Authorities or EMA .
AMSF Is divided into 2 Parts Namely
Open Part / Applicant Part (AP)– Contains information which is non-Confidential like batch analysis, stability etc
Closed Part / Restricted Part (RP) – Contains Confidential Information Like Critical Manufacturing steps etc
Who can file an ASMF ?
Human and veterinary Active Substance Manufacturer can file as ASMF with any EU member state for a national Procedure / DCP Procedure or MRP procedure depending upon the Marketing Authorization Holder process.
ASMF can be filed for
- New ACTIVE Substance
- Substances which is excluded from European Monographs
- Substances Included in European Monographs
How to submit an ASMF ?
All ASMF for Human medicines are required to be filled in eCTD Format with the EU Member state for national, MRP and DCP procedure.
Veterinary ASMF are filed in VNEES and eCTD format depending upon the procedure adopted by the MAA.
ASMF should included Both Applicant part (AP) and Restricted Part ( RP) along with letter of access for the said product.
What is the Difference between ASMF and CEP ?
ASMF are filed parallel or in connection to a Marketing authorization application where as Certificate of Suitability (CEP) can be filled as independent submission with EDQM. CEP Certificate is accepted in EU Member state and many non-EU Countries also.
MAA review time can be shorten if they are using a CEP instead of freshly filed ASMF. CEP can only be applied for products which are official in European Pharmacopeia.
Active substance manufacturer can file both ASMF and CEP for the same API, but both cannot be referred together in the MAA.
How can FDApals help with Active Substance Master File Submission?
We at FDApals can assist you to fulfil your ASMF Submission requirements with ease. Having over 30 years of experience in the field of regulatory filings we can help you
- Review of Documentation for ASMF Submission
- Drafting of ASMF Technical Document
- eCTD/VNEES Publishing of ASMF
- Conversion of Paper document to eCTD
- Reviewing and identifying starting Material for API and Intermediates
- GAP Analysis and designing the limits of Impurities in starting material, intermediated and their carry over to API
- Renewal and Variation filing for ASMF
- Drafting Regulatory Strategy for submission and response to post submission queries.