TAPI to Help Customers with FDA requirements for Priority ANDA Review
By Inbal Hershco-Shani, Associate Director, TAPI Regulatory Affairs
In an effort to encourage generic drug development and increase timely patient access to quality generics, the FDA has agreed to a new provision that would shorten the review process for priority generic drug submissions. Under the FDA's enhancements as part of GDUFA II the review of eligible priority generics will be shortened by two months (8 months initial review, rather than the standard 10 months). Policy MAPP 5240.3 “Prioritization of Review of Original ANDAs, Amendments, and Supplements”, now allows for the prioritized review of generic drug applications until there are three approved generics for a given drug product. This is part of the agency efforts of encouraging generic drug development and increase generic drug access, see here .
According to this guidance, an ANDA applicant who intends to request a priority review for an application upon implementation of this policy, expected October 1, 2017, will need to submit a “Complete and accurate Pre-Submission Facility Correspondence” (PFC).
This Facility Correspondence will have to include the following:
- All facilities involved in manufacturing processes and testing for the ANDA and corresponding Type II API DMF.
- For each manufacturing or testing facility, the correspondence includes facility name, operation(s) performed, facility contact name, address, FEI number (if a required registrant or one has been assigned), DUNS number, registration information (for required registrants), a confirmation that the facility is ready for inspection, a description of the manufacturing process, and a certification by the applicant that any Type II DMF has similarly complete and accurate facility information.
The information submitted in the PFC provides the Agency with the opportunity to determine whether facility inspections will be needed. When deemed necessary, the Agency will initiate inspection planning earlier in the review of the ANDA. Further, it enables FDA to meet the shorter review timeframe (shorter goal dates) for the planned ANDA as defined in the GDUFA II Commitment Letter.
How TAPI can help support you with your application for priority review:
GDUFA II is expected to take effect October 1, 2017 and TAPI has taken actions for those customers who may be requesting priority ANDA review to help them qualify. To contribute to expediting the process, starting from today, TAPI’s new submitted DMFs will include as part of Section 3.2.S.2.1 of the DMF, complete facility information (please contact us to learn about the information we will include) of all facilities involved in manufacturing processes and testing of the final API and a confirmation that the facilities are ready for inspection.
Furthermore, in Module 1 of the DMF we will include a Statement and information about the facility so that our customers can certify to FDA that the DMF contains complete and accurate facility information.
For existing DMFs, TAPI will provide an updated 3.2.S.2.1 Section and a Statement upon customer’s request.
As TAPI’s DMFs are submitted to the FDA 6 months prior to expected relevant ANDA submission and generally pass completeness assessment in a short time (average of 1-2 months), we will thus be ready to support pre-submission facility correspondence (PFC) required for prioritized review applications.
TAPI’s Regulatory Affairs team is fully committed to providing customers with the best support possible to help them have their priority ANDAs eligible for the shortened review. We are available to answer questions and provide whatever information is necessary to help them meet the new criteria and have a smooth and successful review.
Inbal Hershco-Shani is an Associate Director on TAPI’s Regulatory Affairs Team based in Israel. She has devoted her career to regulatory affairs, starting in Teva’s Pharmaceutical Division and joining the TAPI team about one year ago, where she is responsible for Knowledge Management for Regulatory Affairs. She has a Master’s of Science in Medical Science.