Ahead of nearing mandatory eCTD deadline, 5/5/2017, to clear the confusion surrounded, the Food and Drug Administration (FDA) of United States has clarified what exactly it is looking for in the Type III Drug Master File (DMF) submissions. Before jumping straight into what exactly the Type III DMF refer to, let us discuss the DMF and the types in detail.
Drug Master Files & its Types
A Drug Master File or DMF is a confidential, detailed document submitted by a pharmaceutical manufacturer to the US FDA. It mainly contains detailed information about facilities, processes, or ingredients used in the manufacturing, processing, packaging, and storing a concerned drug. According to the FDA, a DMF application is neither approved or disapproved, but its information is used to review an IND, NDA, ANDA, or an Export Application. What kind of information should a DMF contain? Well, it depends on the type of DMF as follows.
Type I DMF: This contains information regarding the manufacturing site, facilities, operating procedures and personnel not specific to any drug substance. The Type I DMFs are no longer accepted by the FDA but the old documents remain on file.
Type II DMF: This contains information related to drug substances, substance intermediates, and materials used in the preparation of a drug, or a drug product. A Type II DMF is the most commonly submitted form among all and can include dosage from drugs manufactured under contract for another company which would file an ANDA.
Type III DMF: This contains information pertaining to packaging materials, right from bottles and caps to PVC resin used during the manufacture of any given drug.
Type III DMF can also be referred to this article’s introduction. In a recent web update, FDA has announced and clarified when and how a Type III DMF needs to be submitted. It is not mandatory that the packaging information be submitted to FDA in the form of a DMF. The one who is submitting the NDA, ANDA or BLA documents or is the sponsor of an IND is responsible to also provide information related to the packaging materials of a given drug. This information is to be provided to the applicant or sponsor by the manufacturer of a packaging component or material of construction and can be directly included in the application instead of a separately filed DMF. However, if there is any information that a manufacturer does not wish to share with the applicant or sponsor (due to proprietary issues), it can be thereby placed in a Type III DMF and included in the application by a letter of consent from the manufacturer to the applicant or sponsor authorizing reference to the DMF.
Type IV: This mainly consists of information regarding the excipient (binding material such as starch or cellulose), colourant, flavour, essence or material used in the preparation of a given drug.
Type V: This contains all reference information pertaining to the drug not included in the previous DMF types.
As we have stressed in our previous articles, beginning May 5, 2017, all new Drug Master Files (DMFs), along with all documents pertaining to existing DMFs must be submitted using the Electronic Common Technical Document (eCTD) format only. If an existing DMF is in paper format with the FDA, one does not require to resubmit it in eCTD format. But any new DMF submission not submitted in the eCTD format after the above-mentioned date would be rejected. Let’s first take a quick look at what is DMF and its different types and later we’ll talk about the impending confusion regarding when a DMF type III needs to be submitted.
With that informed, we would now like to stress more on the FDA’s fast approaching deadline for DMF eCTD submissions. With less than two months’ time in hand, it is the right time organizations should begin implementing the requisite measures for a smooth DMF eCTD conversion/transition as per FDA mandate. To avoid last minute confusion, get insights on DMF eCTD requirements and compliant conversion services.