Regulatory requirements for Post approval changes in Japan, Canada and Malaysia

Abstract

Post approval changes are a vital part of the pharmaceutical product life cycle management. These chemistry, manufacturing and controls (CMC) changes are done due to the changing needs, new findings and for continuous improvement. These changes need to be carefully monitored and must follow a proper regulatory path for implementation. In case of any failure to comply with regulatory requirements for post-approval CMC changes the product will be termed as misbranded or adulterated. Some of the changes may be significant and require a substantial amount of stability data and for the changes which are minor, require only a stability commitment. The change control procedures give the detail on how the changes are evaluated and implemented and how these changes will impact the stability of the product and also information on the necessary data required to support the change.