New draft guidance on the import of unapproved medicines in anticipation of approval in the US has been published by the FDA.
FDA clarifies import rules for 'pre-launch' medicines
New draft guidance on the import of unapproved medicines in anticipation of approval in the US has been published by the FDA.
The new document aims to put a more formal regulatory framework in place for pharma companies that import finished dosage forms manufactured overseas - ahead of US registration - in order to get a new product launch off to the quickest start possible.
The tactic is used particularly by generic drugmakers, who want to make the most of the six-month market exclusivity granted for the company that first files for approval of a new generic medicine.
At the moment the FDA's guidance in this area has been somewhat vague, with the agency dealing with so-called Pre-Launch Activities Importation Requests (PLAIRs) on a discretionary basis.
The draft guidance tries to lay out what information should be submitted the agency in a PLAIR, when and how it can be submitted, and the circumstances under which it can be 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 six months pending a decision on the new drug application," said the agency in a statement.
The agency also notes that PLAIRs can be used for generics, new small-molecule and biologic drugs but should only be submitted if the unapproved finished dosage form is in the final packaged form or requires ‘minimal further processing’. It also stipulates that the product must be identical to that currently undergoing an application review process at FDA.
Any product that requires processing must be delivered to a facility identified in the marketing application and should remain under quarantine there, or at a single GMP-compliant warehouse or distribution facility - until the application is approved.
On approval it can be released into interstate commerce. However, if the application is turned down the product will have to be destroyed or exported within 90 days, says the guidance.
PLAIRs should be filed at least 30 days prior to the anticipated arrival date and no more than 60 days before the deadline for the FDA's review of the application.
The formal document is almost identical to earlier informal presentations made by agency staff on the topic and is open for comment until 23 September.
One issue that seems to have been addressed in the guidance over the earlier informal discussion is that reference to ‘one shipment meaning one entry’ into the US, which has been removed.
Observers had warned that this could be a serious limitation for products whose anticipated sales volumes mean they may need to be imported in quantities that require more than one shipment.