DMF, CTD eCTD, Dossier


(Dattu Wadekar) #1

DMF, CTD eCTD, Dossier.
please give the short information on these.


(Naveen Gouri) #2

Drug master file for API
Comman technical documents for formulation and api


(Helen Crowley) #3

DMF: Drug master file. This is used to register an API with the Health Authorities. Consists of a closed/ restricted part which is only sent to the Health Authority and contains confidential information on the manufacturing process/ control of the API, and the open/applicants part which is sent from the API manufacturer to the drug product manufacturer to include in the drug product (DP) dossier 3.2.S. The API manufacturer must give the drug product manufacturer a Letter of Access allowing the Health authority where the DP is registered to review the closed part of the DMF as part of the review of the DP dossier.

CTD: Common technical document: format that the registration file must follow
eCTD: electronic common technical document. CTD with an XML backbone.
Dossier: Another name for registration file. Contains all the information Module 1, 2, 3, 4 and 5 required to register a DP with a Health Authority