The Pharmaceuticals and Medical Devices Agency (PMDA) has released new guidance addressing the handling of prescription drugs with different crystalline forms (polymorphs). Issued by the Pharmaceuticals and Food Safety Bureau, this provisional guidance aims to establish clear standards for non-proprietary naming, application procedures, and data submission requirements for both new and generic drugs.
The document, originally dated August 1, 2025, and made public on October 6, 2025, emphasizes:
- The importance of differentiating between hydrates and anhydrides in naming conventions without implying changes to the core chemical structure.
- That applications for drugs with distinct crystalline forms should be submitted either as partial change applications or new approval applications, depending on the degree of variation.
- The necessity for applicants to include comprehensive data on crystalline characteristics to ensure consistency and quality equivalence across drug products.
- Specific instructions on Master File (MF) references and contact details for additional regulatory inquiries.
This update reinforces PMDA’s focus on maintaining the integrity and reliability of Japan’s pharmaceutical quality framework.
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