Type 4 drug master files applications

A Type II DMF may be filed for a drug substance (DS) or for a DS intermediate. For NDAs, drug substance information is usually filed in the NDA itself, instead of a DMF. The Agency reviews Drug Master Files only in connection with the evaluation of a filed IND, NDA, AND A, or supplemental application when a letter authorizing such review is provided. There is no regulatory requirement that a DMF be submitted to support any of the above applications. The agency does not approve or deny approval to a DMF. 

Sooner rather than later, CTD-formatted dossiers should also be made acceptable for other types of products (for example generics, line extensions, herbals, radiopharmaceuticals and blood products). Also, applications for clinical trials (for example CTX in the UK, IND in the USA), as well as applications for variations, and Drug Master Files could be formatted according to the CTD guideline. However, before this becomes reality, national regulations and guidelines need to be adapted accordingly. 

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