Pre-Launch Activities Importation Requests (PLAIR)

Pre-Launch Activities Importation Requests (PLAIR)

USFDA’s PLAIR program allows the foreign drug product manufacturer for the importation of an unapproved finished dosage form drug product in preparation for market launch. [Based on anticipated approval of a pending new drug application (NDA) or an abbreviated new drug application (ANDA)].

An overseas manufacturer can import unapproved finished dosage form drug product into the US after the PLAIR has been granted and the Division of Import Operations has been notified of the entry number.

Typically, the PLAIR approval process will take approximately 10 business days from the date of submission; however, the processing time may be longer or shorter, depending on the number of requests received by FDA and other aspects of the request.

A PLAIR amendment can be submitted after the PLAIR has been granted. A PLAIR amendment may take up to 1- 2 business day(s) to process, however, the processing time may be shorter or longer, depending on the number of amendments received by FDA.

Important Facts to Remember

A PLAIR can only be submitted for an original pending application for unapproved finished dosage drug product (no more than 60 days prior to anticipated approval or goal date). It does not apply to approved drug applications with a pending supplement.

A PLAIR can only be submitted for an unapproved finished dosage form drug product (not for API or a bulk drug ingredient).

The PLAIR request should be submitted by the sponsor or the applicant holder on firm’s letterhead.

Before submitting a PLAIR, foreign drug product manufacturer must ensure the actual quantities planned to import.

The quantity of drug product imported into the US must match with the quantity stated in the original PLAIR submission.

The PLAIR request should be submitted only to the email address, CDER-OCPLAIR@fda.hhs.gov, at least one month before the proposed arrival date of the shipment to allow sufficient time to process the request but no more than 60 days prior to anticipated approval.

FDA won’t accept PLAIR requests from distributors, consignees, etc…

A PLAIR may be denied for one or more reasons, including but not limited to:

·       PLAIR was submitted earlier than 60 days of expected approval or decision date.

·       Foreign manufacturer does not have a qualifying facility inspection.

·       Foreign manufacturer is not within GMP compliance.

·       Deficiencies noted in the original application.

Role of U.S. Agent for Importing Food, Drug and Medical Devices in US Market

Role of U.S. Agent for Importing Food, Drug and Medical Devices in US Market

When registering with USFDA for importing food, medical device and drugs, the agency legally insists manufacturing companies located outside of the United States to designate a U.S. Agent for that establishment.  FDA sends communications to U.S. Agent regarding inspections and other regulatory matters, which often require an immediate response.

Information about a foreign establishment’s U.S. Agent is submitted electronically using the FDA Unified Registration and Listing System (FURLS system) and is part of the establishment registration process. Each foreign establishment may designate only one U.S. agent. The foreign establishment may also, but is not required to, designate its U.S. agent as its official correspondent. The foreign establishment should provide the name, address, telephone and fax numbers, and e-mail address of the U.S. agent.

The U.S. agent identified will be required to complete an automated process to confirm that they have agreed to act as the U.S. agent. The automated process will forward an email verification request to the U.S. agent. They will be requested to confirm her/his consent to act as a representative/liaison on behalf of the foreign establishment. If the U.S. agent denies consent (or does not respond within 10 business days), the Official Correspondent/Owner Operator of the foreign establishment will be notified and must designate a new U.S. agent to satisfy the regulatory obligation.

Responsibilities of a U.S. agent

The United States agent must reside or maintain a place of business in the United States and may not be a mailbox, answering machine or service, or other place where a person acting as the United States agent is not physically present. The United States agent is responsible for (defined in 21 CFR 207.69):

(1) Reviewing, disseminating, routing, and responding to all communications from FDA including emergency communications;

(2) Responding to questions concerning those drugs that are imported or offered for import to the United States;

(3) Assisting FDA in scheduling inspections; and

(4) If FDA is unable to contact a foreign registrant directly or expeditiously, FDA may provide the information and/or documents to the United States agent. FDA's providing information and/or documents to the United States agent is equivalent to providing the same information and/or documents to the foreign registrant.

Role of an RLD in an ANDA

Role of an RLD in an ANDA

A Reference Listed Drug (RLD) is an approved drug product to which the ANDA applicant must show its proposed generic drug is the same with respect to active ingredient(s), dosage form, route of administration, strength, labeling and conditions of use, among other characteristics. Also in evaluating drug product formulation and inactive ingredients ,an ANDA applicant must compare its proposed generic drug to the RLD’s formulation.

RLD play an important role in the generic drug development process.FDA requires many rigorous tests and procedures to assure that the generic drug can be substituted for the brand name drug. The FDA bases evaluations of substitutability, or “therapeutic equivalence” of generic drugs on scientific evaluations. By law a generic drug product must contain the identical amounts of the same active ingredient(s) as the brand name product. Drug products evaluated as “therapeutically equivalent” can be expected to have equal effect and no difference when substituted for the brand name product.