FDA submits supply chain security pilot application
Aims to select 100 participants for the two-year programme
The US FDA has submitted a formal application to start a supply chain security pilot for drug product and active pharmaceutical ingredients (APIs).
The initiative was first unveiled in 2009 to assist the FDA in preventing the importation of adulterated or unapproved drugs ‘by allowing the agency to focus its resources on imported drugs that fall outside the programme and that may pose such risks’.
The aim is to select 100 applicants to participate in the two-year pilot who can demonstrate that they maintain tight control over their products from the time of manufacture through to entry into the US.
After vetting by the FDA’s Centre for Drug Evaluation and Research (CDER) and Office of Regulatory Affairs (ORA), companies in the pilot would enjoy faster entry into the US for their drug products or APIs.
In the three years since the announcement of the scheme, the FDA has received a series of comments, which have been published in the Federal Register along with information about how the programme would operate in practice.
The FDA has formally asked for approval of the pilot so that it can meet federal requirements to estimate the burden on the agency's resources of new initiatives and to double check the information that can legitimately be collected from applicants.
If a green light is given by the Office of Management and Budget (OMB) participants will be invited to take part shortly thereafter.
