Importing Drugs with a Pre-Launch Activities Importation Request (PLAIR)

Pre-approval importation requests

FDA reviews requests and may grant permission in certain circumstances for a manufacturer to import a drug in anticipation of the drug receiving FDA approval. When approved, these pre-launch activities importation requests, or PLAIRs, allow drug sponsors to import unapproved finished drugs in preparation for anticipated FDA approval and market launch. 

FDA’s final guidance, Pre-Launch Activities Importation Requests (PLAIR), describes this policy to help ensure timely access to safe and effective drugs.

The guidance describes FDA’s process for PLAIR requests to ensure control and tracking of unapproved drugs awaiting an anticipated FDA approval consistent with the FD&C Act. The policy generally describes that the PLAIR should be submitted no more than 60 days before the user-fee goal date but also allows some PLAIR submissions up to 120 days before the user-fee goal date if the application has a priority review designation.

Application sponsors should use the CDER NexGen Portal to expedite this process. The portal uses multi-factor authentication to ensure data security to protect the integrity of the drug supply chain.