Pre-Launch Activities Importation Request (PLAIR)

This presentation on Pre-Launch Activities Importation Request (PLAIR) is prepared based on the USFDA guidance published in March 2022.

1. 1 Presented by: Sujan Bose

2. Scope of this Guidance 2 This guidance is applicable To raise i mportation request for unapproved finished drug products for U .S. market launch based on anticipated approval of a NDA , ANDA and BLA by applicant . To describes the procedures for making requests for importation of unapproved finished drug products before final approval of the application.

3. Prerequisite for PLAIR PLAIR should be submitted Original unapproved/pending ANDA At least 30 days before the proposed entry (in US) date of the shipment to allow time to process Finished goods are already packed in their final form or minimum further processing required (e.g. final packaging and/or labeling). 3

4. What Should Be Included In A PLAIR? The drug product, name application number, how supplied and precise quantity to be imported. The name of the CDER Office of New Drugs or OGD regulatory project manager assigned to the pending application, NDC number (if assigned) The name, address, registration number, and telephone number of the foreign manufacturer of drug product. The name, address, registration number, and telephone number of the U.S. consignee. A letter of the user fee goal date. The name, address, facility identification number (such as a Data Universal Number or DUNS), and telephone number of any facility where the finished dosage form drug product in final packaged form will be stored pending approval. When the finished dosage form drug product is imported for minimal further processing, information regarding the facility including (1) the name, address, and registration number of the facility; and (2) a description of the further processing activities. This facility should be identified in the pending application. 4

5. What Should Be Included In A PLAIR? A letter signed by an authorized representative of the applicant stating the following: The applicant’s acknowledgment of an unapproved product PLAIR represents request to recondition the product, by obtaining product approval within six months.  An unapproved drug product required for minimal further processing, that will be delivered to a facility identified to permit further processing. For an unapproved drug product in final packaged form that does not call for further processing, should be delivered to a single facility used for warehousing complies with CGMP) and other federal or state requirements. The product will remain subject to the terms and conditions of the Customs and Border Protection(CBP ) entry bond that covers the specific shipment. 5

6. When a PLAIR to be submitted? The PLAIR should be submitted at least 30 days prior to the proposed entry date of the shipment to allow time to process the submission. FDA PLAIR review timeframe as follows: PLAIR-eligible ANDAs, NDAs, and BLAs subject to standard review : The PLAIR should be submitted no more than 60 days before the user fee goal date. PLAIR-eligible NDA for 6 months priority review : The PLAIR should be submitted up to 120 days before the user fee goal date. PLAIR-eligible ANDA for priority review : The PLAIR should be submitted up to 80 days before the user fee goal date. 6

7. What Action Will FDA Take On A PLAIR? The CDER Office of Drug Security, Integrity, and Response (ODSIR), Division of Global Drug Distribution and Policy (DGDDP), will confirm receipt of the submission. CDER will review the submission and assess : the foreign facility’s inspection history and conformity with applicable cGMPs . After that, the DGDDP will notify the applicant whether the PLAIR has been granted or denied. 7 How should a PLAIR to be submitted? The PLAIR submission should be on the applicant’s letterhead and submitted by email to [email protected] in a PDF. The subject line of the submission should include the application number, drug product name and strength(s). Only one PLAIR submission will be accepted per NDA, ANDA, or BLA.

8. Is amendments of a PLAIR accepted? The firm may make the changes on the initial PLAIR. If any changes to the PLAIR are proposed after FDA has granted the original PLAIR submission, an amended PLAIR should be submitted to FDA. However, the firm should explain all changes made and identify the document as an “amendment” to differentiate it from the initial PLAIR request. After review, DGDDP will notify the applicant whether it has granted the amendment. 8

9. 9 Importation Of New Drugs Under An Approved PLAIR The importer may provide a copy of the granted PLAIR to the ORA Import Division where the product is being imported. Approval of the PLAIR The drug (required minimum processing) arrives in US port of entry. Intend to detain the product for up to 6 months of pending ANDA FDA will issue ‘’ Notice of FDA Action – Detained’’ Approval of ANDA Refuses to approve the application or 6 months elapse without FDA approval Drug product must be exported or destroyed within 90 days FDA will issue “Release after Detention.” “Notice of FDA Action -Refusal of Admission.” From the date of any notice of refusal.

10. Post-NDA, ANDA, or CDER-Regulated BLA Approval A pplication is approved - I mmediately send a copy of the approval letter to the ORA Import Division where the product was detained and [email protected] . The applicant should notify FDA of any deviation of the drug product detained under a PLAIR from the provisions in the approved drug application 10

11. 11 Feel free to raise your questions

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