Update From FDA on its Secure Supply Chain Pilot Coming Soon; Regulation, Legislation and Guidance Efforts Advance in US and EU

A status update and further announcements from FDA on its “Secure Supply Chain” (SSC) pilot program, intended to help promote the safety of active ingredients and drug products imported into the US, are expected soon.

Since announcing the pilot in 2009, the agency has been working with the US Customs and Border Protection (CBP) agency on how to apply the priority “green lane” processing provided for companies with secure supply chains under CBP’s Customs-Trade Partnership Against Terrorism program, and the application review process for the FDA pilot has not yet begun. The pilot is slated to last two years.

To qualify, applicants will need to meet the pilot program’s criteria, including a requirement that they maintain control over the drug products from the time of manufacture through entry into the country. Qualifying firms would get expedited clearance for US entry for specified products.

The proposed plan calls for 100 applicants to participate in the pilot program. Each applicant, in turn, may designate up to five drugs for inclusion.

[More on FDA’s SSC pilot and a review of current regulation, legislation, and guidance supply chain initiatives in the US and EU is provided for subscribers here. For further insights on supply chain issues and developments see the September 9 companion stories.]

Editor’s note:  IPQ has been closely tracking industry and regulator supply chain initiatives since its launch in the fall of 2007.  For example, the November/December 2008 IPQ Report provides an in-depth analysis of the drug supply chain problems and the industry and regulatory efforts to address them on an individual company, regional and global basis. IPQ’s May/June 2008 Report focuses on hearings in the US Congress to reevaluate FDA resourcing and authorities in the wake of the heparin problems.

The following are IPQ “In the News” stories that provide updates on recent developments in regulatory and legislative efforts to help secure the drug supply chain:

FDA Shares Concerns, Expectations Regarding Pharma Cargo Thefts (May 11)

EU and Cambodia Take Steps to Fight Counterfeit Drugs (June 9)

FDA Fast-Tracking Supply Chain cGMP Upgrades; Other GMP Changes, Quality Agreement Guidance Taking Shape (June 16)

EU Moving to Tighten GMP Requirements on Outsourcing and Supply Chain Control (June 16)

New Senate Bill Proposes Supply Chain Requirements for Drug Firms, Mandatory Recall Authority for FDA (August 11)

EMA Issues Q&A on Supply Chain Traceability to Support Revised Medicinal Gas Annex (August 16)