Suzhou, China – January 28, 2026 – A regulatory authority has released the world's first guideline dedicated specifically to polymorph research for innovative chemical drugs, providing a structured and science-driven framework for solid-state control in CMC development.
Crystal Pharmatech contributed technical input during the drafting process and has prepared an English translation to support broader global access and cross-border scientific alignment.
The guideline outlines clear, practical expectations across key areas, including:
Polymorph selection, characterization, and risk assessment
Control strategies for both drug substance and drug product
Crystallization, drying, and milling processes
Manufacturing and stability considerations
By articulating consistent scientific principles and control logic, the guideline helps reduce uncertainty in polymorph strategy and supports more robust, first-time-right CMC development—regardless of development geography.
For teams advancing innovative chemical entities globally, this document serves as a technically rigorous reference for aligning solid-state strategy with evolving regulatory expectations.
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To request the English PDF, please contact: bd_global@crystalpharmatech.com
