Post-approval changes in the US

Changes to products licensed by the US FDA are achieved via the provision of supplements to the original new drug application (NDA).

AR: Annual Report

Changes that can be submitted in an annual report are of a minor in nature and that have minimal potential to cause an adverse effect on the identity, strength, quality, purity, or potency of a drug product as these factors may relate to the safety or effectiveness of the drug product.

 The affected product can be distributed at any time after the change has been internally approved and before the details are reported in the Annual Report.

At the end of a reporting period, any changes that have been implemented in the previous year are included together in a single notification to the agency.

CBE-0: Changes Being Effected 0

Changes classified as CBE-0 are minor (albeit moderate) changes to the product which can be implemented from when the FDA receives the supplemental new drug application (sNDA) application.

The product can also be distributed when the supplemental new drug application (sNDA) is received and CBE-0 changes are considered approved six months after receipt, if there are no technical issues raised by the FDA.

However, if the change is not approved then distribution must cease and a product recall may be required.

CBE-30: Changes Being Effected 30

Changes classified as CBE-30 are also deemed as minor (albeit moderate) and  Changes in this classification can be implemented and product distributed at risk, 30 days after the FDA receives the supplemental new drug application (sNDA), unless the FDA notifies the applicant otherwise.

Approval should be completed after six months, however, if the submission is rejected, a recall may also be required.

PAS: Prior Approval Supplements

This category covers major changes that are considered to have a substantial potential to adversely affect the identity, strength, quality, purity or potency of the drug product.

Product affected by these changes cannot be distributed until approval which should take up to four months, assuming there are no technical issues.


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