FDA safety pilot for drug imports
The U.S. Food and Drug Administration has started a two-year voluntary pilot program that it said would help promote the safety of drugs and active drug ingredients manufactured overseas and imported into the United States.
The FDA plans to select 100 applicants to participate in the Secure Supply Chain pilot program.
'The goal of the pilot is to allow FDA to determine the practicality of developing a secure supply chain program,' the agency said in a statement on Wednesday. 'Such a program would assist the agency in its efforts to prevent the importation of drugs that do not comply with applicable FDA requirements by allowing the agency to focus its resources on foreign-produced drugs that fall outside the program and that may not be compliant.'
The FDA said products that meet the pilot's criteria should expect faster entry into the United States. The pilot was developed with input from Customs and Border Protection and other stakeholders, the agency added.
Companies wishing to participate in the pilot must meet the following criteria:
' For finished drug products, the applicant must hold an FDA-approved drug application or must be the foreign manufacturer identified in an FDA-approved application.
' The active pharmaceutical ingredients imported must be used only to make FDA-approved drugs.
' Foreign drug manufacturers and U.S. establishments receiving drugs must be FDA-registered and comply with the Good Manufacturing Practices.
' Applicants must show that their drug products use a secure supply chain.
The application for the program is available here. The Federal Register notice announcing the Secure Supply Chain pilot may be viewed here.