A Significant Step Toward Greater Clarity in Polymorph Control for Innovative Drugs
Suzhou, China – January 28, 2026 – Center for Drug Evaluation, National Medical Products Administration (CDE, NMPA) 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.
Polymorph selection, characterization, and risk assessment
Control strategies for both drug substance and drug product
Crystallization, drying, and milling processes
Manufacturing and stability considerations
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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