Under the policy drug firms no longer need to notify the US Food and Drug Administration (FDA) if they change a supplier as long as the new capsule is consistent in composition and appearance with the original.
Instead such information can now be detailed in an annual report to the Agency.
Previously, firms that changed hard gel capsule supplier were required to ask the agency for permission by submitting a prior approval supplement (PAS). Now only companies that switch to a capsule that differs from the original must file a PAS.
Changes detailed in annual reports must include the supplier's name and address, certification that the gelatin it uses complies with USP/NF standards and is free of Transmissible spongiform encephalopathies (TSEs) and general specifications about the capsule.
Industry response
Trevor Lewis, VP of Quality and Regulatory, at Qualicaps North America welcomed the US FDA policy.
He told us: “Qualicaps is pleased to see the updates to the FDAs new guidelines on capsule equivalence. The new guidelines provide opportunities for companies to insure their supply chain is more easily protected and that the patient is never at risk of not receiving their medicine.”
Similarly, a Capsugel spokesman told us: "The FDA’s policy enhances clarification regarding what many of our pharmaceutical customers already consider common practice."
He added that: "As such, we don’t expect this to have a material impact on our business or industry dynamics. We will continue to partner with our customers from R&D development all the way through commercial manufacturing."