PDA Asks for Input on CMC Post-Approval Changes

The Parenteral Drug Association (PDA) has established a taskforce to explore opportunities to reduce the complexity of chemistry, manufacturing, and controls (CMC) regulatory post-approval change (PAC) processes and is conducting a survey to collect data on current (CMC) PAC processes. With current divergent requirements, PDA wrote in the letter on Dec. 15, 2016, the path to global approval of a post-approval change may increase the risk of drug shortages and incentivizes companies to keep things the way they are rather than facilitating modernization, maintaining a state of control, and achieving product realization-the objectives of International Council for Harmonization (ICH) Q10.

PDA is inviting individuals challenged by the complexity of making PACs to complete the survey. The association says it will release preliminary results at the 2017 PDA Annual Meeting from April 3–5, 2017 in Anaheim, CA. The survey will be available for completion until February 15, 2017. Anyone with questions is encouraged to contact Morgan Holland, of the PDA Science and Regulatory Affairs Department.