FDA published a guidance in May 2015 announcing a deadline for electronic submission of active DMFs. As per these guidelines, DMF holders are required to submit the baseline submission that generally includes the Module 1, 2 and 3 of the present submissions. This submission should also take account of the most recent paper submissions if any. All these submissions are intended to be converted into eCTD format in addition to the succeeding submissions such as authorization letters. Companies need to focus on conversion of their DMF legacy paper format through implementation of effective eCTD lifecycle processes.
DMF submissions are only referred to NDA, abbreviate new drug application (ANDA) and investigational new drug (IND). However there is only a review process for DMFs and no approval process is followed by FDA. Submitting the DMFs annually is the best recommended practice for DMF holders. Failing to submit three consecutive DMF submissions, FDA may close the respective DMF.
As per the Generic Drug User Fee Amendments of 2012, DMFs that cover the manufacture of an API (Type II API DMFs) for use in a generic drug application need to pay DMF fees and it is one-time fee.
The DMF fee for fiscal year (FY) 2016 (October 1, 2015 to September 30, 2016) is $42,170.Fees for FY 2017 will be adjusted. Fees will be published in the Federal Register no later than 60 days before the start of each fiscal year. If any facility failure to pay DMF fee then that DMF will not be available for reference.
Who should be filing DMF?
To answer this, let’s first understand what DMF is. A DMF in US is a submission to the FDA that includes broad confidential information about an Active Pharmaceutical Ingredients (API) in terms of its manufacturing, facilities, procedures, processing, packaging and storing. Generally a company manufacturing an API works collaborate with another firm that develops a drug around that specific API to be ready for human consumption. In such scenarios, to look after its confidential assets from its partner, the company files its DMF while following the regulatory guidelines of disclosure of processes essentials.
Types of DMF Submissions
In United States, DMF is classified into following categories:
- Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
- Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
- Type III: Packaging Material
- Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
- Type V: FDA Accepted Reference Information
Freyr being one of the strategic partner for global giants aims to simplify the entire DMF filing. As an integral part of the filing process, Freyr has helped its clients in:
- Providing a checklist encompassing documents to be submitted to agency by client
- Creating ER and GDUFA SPLs for self-identification of facility and submitting them to the agency.
- Writing documents with help of the raw data provided by the client in CTD format
- Creating eCTD package with XML backbone and validations the package.
- Maintaining the lifecycle of the DMFs
- Submitting the reviewed submissions to US FDA via ESG gateway
- Creating a conversation bridge between the client and FDA with help of our experts in order to interest client queries if any
- Providing guidance for annual facility fee payments on creating coversheets and initiation of payment process.
- Providing US agent services for foreign manufacturing Facilities.
- Following up with FDA whether Initial Complete Assessment is done for submitted DMFs.
- Requesting for pre-assigned application number for eCTD submissions on behalf of API manufacturer.
- Creating Baseline submissions for paper DMFs.
Freyr provides flexible, end-to-end DMF submission services for the review of APIs by Global Health Authorities that enable companies to effectively meet all their specific and unique submission and publishing requirements.