The things about (DMF)

The things about (DMF)
 
Introduction of DMF
In the field of pharmaceutical trade, DMF is a very important part, his full name is Drug Master File. All drugs exported to foreign countries, whether API or formulations need to submit drug registration documents to the drug regulatory agencies, such documents are uniformly known as DMF.


How many types of DMF are there?
Common DMF can be divided into five categories based on the content, the nature of these five types of DMF are different, each declaration of DMF can only be one of these five categories and can not be mixed, the next we introduce these five types of DMF.
Class I DMF: Factory sites, plants, personnel facilities; class II DMF: raw materials; class III DMF: packaging materials; class IV DMF: pharmaceutical excipients and other Additives such as falvors; class V DMF: clinical and non-clinical data
 
For API, there are two main stages of FDA approval. The first stage is the DMF registration, which requires the submission of a DMF document that describes the entire process of production and quality management of the drug produced as well as the quality of the drug itself, which will be reviewed by the FDA. The second stage is when the DMF audit has been completed, the FDA will conduct a GMP compliance site inspection of the manufacturer of the API, and finally make a decision on whether to approve the drug for marketing in the United States.
 
Most countries’ health department are not so fond of handling DMF because the number of documents in DMF is usually large, and many drug master files also have CTD templates and many copies of documents, which causes a lot of time and space to be spent trying to store these documents safety. Of course this problem can be solved by submitting an electronic version of the DMF, but not all countries accept electronic of the DMF, there are still many countries need to provide a paper version of the DMF drug master file.

Future trends of DMF
Countries around the world are now from the traditional paper DMF documents submitted and approved to submit electronic documents to promote the model, although in some countries health departments still require API manufacturers to provide a series of complicated and bulky paper version of the document, but the submission of electronic DMF has long become a trend. The future of the world will generally accept a unified electronic format and related DMF files, but there is still a long way to go.