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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
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Regulatory News | 15 August 2016 | By Michael Mezher
Changing the supplier of gelatin capsules used to encase drugs constitutes a minor change, and does not require a prior approval supplement (PAS), according to a US Food and Drug Administration (FDA) policy that went into effect Monday.
When a drugmaker makes changes to an already approved product, including changes to its specifications, manufacturing process or label, the company must notify FDA of the change.
Depending on the seriousness of the change, (e.g., whether the change has significant, moderate or minor potential to affect the safety or efficacy of a product), FDA may require companies to get approval before instituting the change via a PAS.
However, when the change is considered minor, drugmakers are only required to notify the agency in an annual report to the agency.
According to the policy, FDA's Office of Pharmaceutical Quality (OPQ) says that merely changing the supplier of a hard gelatin capsule is a minor change and should only be included in an annual report.
The policy also states that if FDA receives a PAS containing a change in supplier, the agency will inform the supplier that the information needs only be included in an annual report.
Specifically, the policy says the annual report should include the following information:
However, FDA says that any change in the capsule's composition or appearance, including any changes in size, color, or dye, or a change from gelatin to a non-gelatin alternative, would require a PAS.
Tags: Prior Approval Supplement, Gelatin Capsules, Supplier Change