FDA looks to start supply chain security programme
pharmafile | June 26, 2012 | News story | Manufacturing and Production |Â Â CDER, FDA, OMB, ORA, manufacturingÂ
The FDA has submitted a formal application to start a supply chain security pilot programme for overseas manufacturers of finished pharmaceuticals and active substances.
The voluntary scheme was first unveiled in 2009 in the wake of the adulterated heparin scandal, and was billed as way 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 Center for Drug Evaluation and Research (CDER) and Office of Regulatory Affairs (ORA), companies in the pilot would enjoy expedited entry into the US for their medicines or active pharmaceutical ingredients (APIs). If the pilot is successful, the expectation is that it could be rolled out on a much larger scale.
In the intervening years since it was first announced, the FDA has received a series of comments about the proposed pilot, which have been published in the Federal Register along with information about how the scheme would operate in practice.
The FDA has formally asked for approval of the pilot in order to 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.
Phil Taylor
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