The FDA issued the final guidance “Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA.”
This final guidance assists original applicants and holders of approved new drug applications, abbreviated new drug applications, and biologics license applications with implementing chemistry, manufacturing, and controls (CMC) postapproval changes through the use of comparability protocols.
A comparability protocol is a comprehensive, prospectively written plan for assessing the effect of proposed postapproval CMC changes on the identity, strength, quality, purity, and potency of a drug product as they may relate to the safety or effectiveness of the product.
In many cases, submission and approval of a comparability protocol will facilitate the implementation and reporting of the proposed CMC changes, which could result in moving a drug or biological product into distribution or facilitating a proactive approach to reinforcing the supply of a product sooner than if a comparability protocol were not used.
This final guidance describes the types of CMC changes that can be addressed in a comparability protocol submission, as well as the information to be included in the comparability protocol and how to implement and report the CMC changes. Additionally, this final guidance recommends a framework to promote continuous improvement in the manufacturing of quality drug and biological products.
FDA finalized this guidance based on comments received on the revised draft guidance published on April 20, 2016, entitled “Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information.” The final guidance contains edits to these sections and more:
- Products to which this guidance is applicable;
- Information to be described in the comparability protocol;
- Implementation of the CMC changes described in the comparability protocol;
- Updates to the Questions and Answers section.
