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2013-07-24 FDA,Lachman CONSULTANTS

Notice to Industry: FDA Issues Draft Guidance for Pre-Launch Importation Requests (PLAIR)
Notice issued: July 24, 2013

• Plair，即Pre-launch Activities Importation Request
  
• 同时适用新药、仿制药、生物制品，仅适用于制剂产品
  
• 指南内容包括，如何申请Plair、基于Plair的进口流程、批准上市后的活动
• 重点说明了Plair的要素

The FDA today issued a draft guidance to industry, outlining the agency's policy on the importation of unapproved finished drug products in anticipation of approval and market launch of a pending new drug application (NDA), abbreviated new drug application (ANDA) or biologics licensing application (BLA) regulated by FDA's Center for Drug Evaluation and Research (CDER).

This guidance outlines:

• what information a sponsor should submit to FDA in a pre-launch importation request (PLAIR)
  
• when and how a PLAIR should be submitted, and
  
• the circumstances under which FDA intends to grant a PLAIR.
  

Once a complete PLAIR is submitted, CDER will review the submission and let the applicant know whether the PLAIR has been granted. If FDA grants the PLAIR, the Agency will detain the unapproved drug when it is offered for import for a period of up to 6 months pending a decision on the new drug application. If and when CDER approves the new drug application, FDA's Office of Regulatory Affairs will make the admissibility decision for the drug import.

Although sponsors may comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers industry comments on the draft guidance before it begins work on the final version of the guidance, electronic or written comments on the draft guidance should be submitted by September 23, 2013. Electronic comments on the draft guidance should be submitted to http://www.regulations.gov. Written comments should be mailed to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Federal Register Notice

A Flair for the PLAIR
Written by Bob Pollock • July 24, 2013
First, what is a PLAIR? It stands for Pre-Launch Activities Importation Request. It is used to bring unapproved drug product into the United States in anticipation of imminent approval of the product. The process has evolved over the years, but is still decided on a case-by-case basis. In its infancy, the process (which was really not well-defined at the time) actually became a barrier for foreign applicants, or for domestic applicants that utilized foreign manufacturing sites, or foreign contract manufacturers seeking to be on an even footing with US domestic manufacturers, and applicants who typically launched immediately at the time of patent expiration or application approval. Over the course of time, the process was refined to become what today is the PLAIR. Over the last few years, the FDA had issued some informal directions in the form of an instructions sheet (here) and a Question and Answers document (here ) .

Today the contents of those documents have been incorporated into a Draft Guidance (here ). The FDA says in its guidance that “[H]istorically, when applicants sought to import unapproved finished dosage form drug products in preparation for market launch, FDA considered such requests, informally referred to as Pre­ Launch Activities Importation Requests (PLAIRs), on a case-by-case basis. FDA has decided to create a more formal program, and this guidance outlines what information should be submitted to FDA in a PLAIR, when and how a PLAIR can be submitted, and the circumstances under which the Agency intends to grant a PLAIR.”

The PLAIR can be used for a New Drug Application (NDA), Abbreviated New Drug Application (ANDA) or Biologics License application (BLA) that is nearing approval. If FDA grants the PLAIR, the firm may import the product into the US, and the FDA will “detain” the product (permit import, but not distribution) for up to 6 months. During that time, the FDA expects that owner or consignee to “recondition” the product by obtaining the required approval from FDA. Once the FDA approves the application, the FDA will release the product for distribution if all of the conditions of the PLAIR are met.

PLAIRs will be permitted for drug products in final dosage form only and will be authorized for products that require only minimal further processing, e.g., final packaging or labeling, or are in final packaged form. The Guidance document provides a list of information that must be in the PLAIR for FDA consideration to be complete.
Products brought into the US under a PLAIR must be stored under quarantine at a single site, pending final approval of the application. Time frames for submission of a PLAIR are also outlined in the Guidance document. The process is also now electronic, and thus, should speed up decisions on the PLAIR (once submitted) and will eliminate the loss of paper documents. If the application is not approved within 6 months of admission into the US, or the conditions of the PLAIR are not otherwise met, the FDA will refuse admission. If that occurs, the owner or consignee will have 90 days to export or destroy the product.
Once approved, the applicant is instructed to e-mail a copy of the approval letter to the District Office and to DIOP Plair@fda.hhs.gov.
The process of staging unapproved drug in the US from foreign manufacturing sites has long been a troublesome process prior to final approval, or for firms that needed to perform final packaging or labeling in the US. Over time, the process has become more formalized and standardized to ensure consistency. The issuance of this draft Guidance regarding the PLAIR process should make this process more transparent and understandable for the pharmaceutical industry. For additional questions regarding the PLAIR process or importation of unapproved drug products into the US, please contact Joan Janulis at j.janulis@lachmanconsultants.com.