The Food and Drug Administration (FDA) announced a pilot program that will allow for expedited entry of imported drugs into the United States.
The announcement outlines the eligibility requirements and the process for applying for participation in the Secure Supply Chain Pilot Program (SSCPP).
With the program scheduled to launch next February, the agency plans to accept applications – on a first-come, first-served basis – from Sept. 16 through Dec. 31. The SSCPP is intended to be a two-year pilot, from February 2014 through February 2016.
The pilot, which has been in the works since 2009, is a voluntary pilot program, designed to expedite entry into the U.S. of specific approved drugs and active pharmaceutical ingredients (API), allowing the FDA to focus its limited resources on preventing the importation of drugs that don't comply with its requirements.
According to statement issued by the agency, the FDA plans to increase the rate at which entries of the finished drug products and active pharmaceutical ingredients selected for the pilot program are given a "may proceed" without human entry review or examination.
Drug companies hoping to join the pilot run must meet FDA criteria showing that they maintain control over the drugs from manufacture through entry into the U.S. Each participant will be restricted to no more than five drugs on the test.
Besides having a history of compliance, drug makers participating in the SSCPP will be required to have a plan in place to promptly correct concerns the FDA identifies regarding their supply chain or specific imports.
They also must have a plan to recall or correct finished drug products or APIs that don't meet, or weren't manufactured in accordance with, agency requirements.
Rachel Shmilovich, national supervisor of good manufacturing practice (GMP) at the Ministry of Health has urged Israeli firms to join the Secure Supply Chain Pilot Program.