> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Draft Guidance on Comparability Protocols for CMC Changes
- URL: https://www.fdaweb.com/draft-guidance-on-comparability-protocols-for-cmc-changes/
- Published: 2016-04-19T12:00:00.000Z
- Updated: 2026-09-14T20:55:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135426

> FDA has posted a [draft guidance](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM496611.pdf?ref=fdaweb.com) on “Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls (CMC) Information” that provides recommendations on implementing a CMC postapproval change under a comparability protocol (CP). “Submission of a CP in an original application or prior approval supplement (PAS) allows the agency to review a description of one or more proposed CMC postapproval changes, supporting information including any analysis and risk assessment activities, a plan to implement the change(s), and, if appropriate, a proposed reduced reporting category for the change(s),” the document says. Such a strategy can provide a sponsor with an agreed-upon plan to implement the specified changes, and in many cases, a justification to report them in a reduced reporting category, which is contingent upon the sponsor’s data analysis after the change is completed. “In many cases, using a CP will facilitate the subsequent implementation and reporting of CMC changes, which could result in moving a product into distribution or facilitating a proactive approach to reinforcing the drug supply chain sooner than if a protocol were not submitted,” the agency says.