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US FDA issues draft guidance on use of drug master file for shared system REMS submissions

Nandita Vijay, Bengaluru
Tuesday, November 14, 2017, 08:00 Hrs  [IST]

The USFDA has issued a guidance on use of a drug master file(DMF) for shared system REMS(risk evaluation and mitigation strategy) submissions This guidance provides recommendations for applicants that are part of a shared system REMS on using an electronic Type V2 Drug Master File (DMF) for shared system REMS (SSR) submissions. The recommendations in this guidance are intended to improve the efficiency of submitting SSR to the regulatory authority.
The use of a DMF is not a requirement for SSRs. However, if applicants that are participating in an SSR choose to use a DMF, this guidance provides an overview of a recommended approach for their SSR submissions.

A REMS is a required risk management plan that uses tools beyond the FDA-approved prescribing information to ensure that the benefits of certain drugs outweigh their risks. The regulator can, under certain circumstances, require that the REMS for a drug include one or more elements to assure safe use (ETASU). When ETASUs are required for an innovator drug, any abbreviated new drug application (ANDA) referencing that innovator drug must use an SSR with the innovator. There are also circumstances under which multiple applicants form an SSR to minimize the burden on the health care delivery system, such as for a class of similar products.

A DMF is a voluntary submission that may be used to provide confidential detailed information to the Agency. The DMF holder may authorize other applicants to reference information in the holder’s DMF. It is submitted solely at the discretion of the DMF holder, and its  technical contents are customarily reviewed by the regulator only in connection with the review of an application. There are several types of DMFs; a Type V is used for FDA-accepted reference information.

As part of an SSR, multiple applicants need to coordinate the submission of identical REMS-related documents by each applicant to its own application. To improve the efficiency of the submission and review process for SSRs, FDA recommends that applicants use a Type V DMF for their SSR submissions.

The DMF holder must submit letters of authorization (LOAs) to the DMF that permit FDA to review information in the DMF in support of the SSR applicants’ applications. The DMF holder should submit a separate LOA to the DMF for each SSR applicant. If an SSR applicant is also the DMF holder, an LOA should still be submitted to the DMF. The DMF holder does not need to submit a new LOA for each new submission to the DMF unless there is a change in the DMF holder name or the authorized party name.

The DMF holder should also send a copy of the LOA to each SSR applicant who has been authorized to incorporate the information contained in the DMF by reference. Each SSR applicant should then submit the copy of the LOA to its own application. SSR applicants only need to submit this LOA to their application one time unless there is a change in the DMF holder name or the authorized party name.


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