After some considerable delay, a US Food and Drug Administration (FDA) pilot programme aimed at easing the importation of active substances and finished medicines in the US got underway this week.
The two-year Secure Supply Chain Pilot Programme (SSCPP) is designed to allow the FDA to focus its surveillance efforts on high-risk shipments that are most likely to be adulterated or counterfeited, whilst cutting red tape and delays for low-risk imports.
The FDA first mooted the idea of a voluntary, risk-based pilot for medicinal product imports back in 2009, when it said the overall objective was to "determine the practicality of developing a secure supply chain programme."
The pilot includes a qualification component, which will allow 100 pre-approved applicants to have up to five of their products cleared for expedited import review.
Companies who apply to take part must be the sponsor holding the approval for the imported active pharmaceutical ingredient (API) or finished drug - or the designated overseas manufacturer - and must have been shown to be compliant with Good Manufacturing Practice (GMP).
Applicants will also demonstrate a commitment to securing their drug supply chains as participants in the Customs-Trade Partnership Against Terrorism (C-TPAT), according to the FDA, which started accepting applications on September 16.
The deadline for applications is December 31, and it is expected that the programme itself will take place between February 2014 and February 2016.
The initiative recognises that up to 40 per cent of the drugs Americans take are manufactured outside US borders, while up to 80 per cent of the APIs in those drugs come from foreign sources, and the FDA will never have the capacity to screen all imported shipments.
The FDA implemented a series of initiatives to try to shore up the security of its borders from illicit and substandard products, including an electronic screening tool call PREDICT (Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting) that works behind the scenes to screen all lines of imported product electronically submitted to the FDA via a US Customs and Border Protection (CBP) interface.
The PREDICT system started to roll-out in 2009 and was used in all 16 of the FDA's import districts in December 2011.
A raft of additional supply chain security measures have been mandated by last year's Food and Drug Administration Safety and Innovation Act (FDASIA), including new powers for the destruction of adulterated, misbranded or counterfeit drugs, revisions to the regulations covering GMP, registration of commercial importers of medicinal products and tougher penalties for counterfeiting and intentional adulteration.
It is thought that the delay to the SSCPP in part resulted from a desire to make sure that the pilot is in alignment with FDASIA.