
PDA Asks for Input on CMC Post-Approval Changes
PDA is conducting a survey of industry members challenged by the complexity of making 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
Source: PDA
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