PLAIR - new FDA Guideline regulates Import of non-approved Drugs in the Run-Up to the Launch in US

Recommendation

28-30 March 2023

Global Registration and Life Cycle Management of APIs - Live Online Training
Contents of the regulatory information in the ASMF and CEP

Applicants expecting an approval for their product for the American market are usually striving to receive an import permit for the still-unapproved drug from the FDA. This way they want to be prepared for the day when the approval letter arrives to be able to serve the American market without delay. This "pre-launch activities importation request" (PLAIR) is currently still regulated on a case by case basis. However, according to the FDA these regulatory practices are supposed to be replaced by a standardised approach. The FDA has therefore developed a guideline draft entitled "Guidance for Industry - Pre-Launch Activities Importation Request (PLAIR)". 

The "PLAIR guidance" describes when such an import permit request has to be submitted, what information and documents have to be included and under what circumstances the FDA grants the permission. In a PLAIR, the applicant has to confirm the following:

• By contractual agreement with the applicant The finished product is delivered to a single site (warehouse or distribution facility) controlled by or under contract with the applicant. It is subject to customs regulations and remains there in quarantine pending final approval of the drug product. The same applies for bulk products, i.e. for the case that a minimal further processing is necessary for manufacturing the finished product.
• The warehouse is run according to cGMP principles. In particular, the requirements laid down in 21 CFR 211.42 ("design and construction features") and 21 CFR 211.46 ("ventilation, air filtration, air heating and cooling") are fulfilled.  

A PLAIR should be submitted at least 30 days prior to the proposed arrival date of the delivery in the United States, but not earlier than 60 days before the user fee goal date for completion of the review of the pending application for approval. 

If a letter of admission is provided in a period of 6 months after the arrival of the shipment and if all requirements of the PLAIR are met the authority releases the medicinal product (or the bulk goods). If, however, this letter of approval is not provided in the 6 months period or if the approval is denied the product must be re-exported or destroyed (after 90 days at the latest).  

The guidance has been published for comment; Comments can be filed directly through the Federal Register or through the "Regulations.gov" page of the eRulemaking Program Management Office.