FDA finalizes guidance on pre-launch drug import policy

Regulatory NewsRegulatory News | 03 March 2022 |  By 

The US Food and Drug Administration (FDA) on Wednesday finalized guidance to assist sponsors in submitting requests to import unapproved finished drugs prior to market launch of a pending new drug application (NDA), abbreviated new drug application (ANDA) or biologics license applications (BLA).
The guidance outlines the procedures for making these requests under the agency’s Pre-Launch Activities Importation Requests (PLAIR) program and FDA’s timetable for approving requests.
The final guidance “largely tracks the July 2013 draft guidance,” said an FDA  announcement.
FDA said that prior to issuing draft guidance, requests to import unapproved drugs were on a case-by-case basis.
One change made to accommodate public comment was to provide earlier timeframes for submitting requests for PLAIR-eligible products subject to priority review.
The guidance states that “for PLAIR-eligible NDAs and CDER-regulated BLAs subject to 6-month (priority) review, the PLAIR should be submitted up to 120 days before the user feel goals date. For PLAIR-eligible ANDAs subject to priority review, the PLAIR should be submitted up to 80 days before the user fee goal date.
For applications subject to standard review, the PLAIR should sent in at least 30 days prior to the proposed entry date of the shipment and no more than 60 days before the user fee goal date.
To be eligible for PLAIR, the drug must need “minimal further processing” in terms of packaging and labeling and the product should be delivered to a single facility for warehousing. The warehouse facility must comply with good manufacturing practices (GMPs). Further the drug must be exported or destroyed within 90 days of being refused admission.
Upon receiving notice that the drug has been approved, applicants should “immediately” send a copy of the approval letter to Office of Regulatory Affairs (ORA) import division where the product was detained.
Applicant should ensure that any last-minute changes made to the drug have been reflected in the labeling. FDA states that “in the past, the agency has encountered instances in which drug products that had been warehoused subject to a pending drug approval did not conform with late changes made to the approved drug labeling or instances in which the application did not receive FDA approval.”
Final guidance


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