Synopsis: The document discusses the implementation of ICH guidelines for generic pharmaceuticals in Japan, highlighting the need for international harmonization to clarify review standards and promote flexible quality management practices.
The document provides the following information:
- It specifies that these guidelines will apply to new manufacturing and marketing applications starting 01-Apr-2026, while biological products and special quality management drugs are excluded
- Stability testing and compliance with the Q1 series guidelines are emphasized, including the necessity for long-term stability results that reflect storage conditions
- The consultation with the Pharmaceuticals and Medical Devices Agency is advised for any deviations in testing protocols
- Additionally, it outlines the importance of adhering to quality management standards, considering differences in storage and shelf life between generic and brand-name drugs, and confirms that the current regulatory framework remains unchanged for generic drugs unless stated otherwise
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