We would like to import Japanese medicinal products. According to Japanese regulations described by Japanese manufacturers, if a shelf life of 3 or 5 years has been granted with sufficient long-term stability data in the first-approved drug application, the subsequent applicants of generic drug products can perform a 6-month study at the accelerated storage condition only. Long-term stability test is not required for the subsequent generic drug application in Japan. Will the regulation follow accordingly in Taiwan?

刊登日期:2019-11-13  |  點閱次數 : 2829 次 

No. According to Guidelines on Stability Testing of Drug Substances and Products (MOHW No.1041408733), data from stability studies should be provided on at least one pilot scale batch of the drug product. The long term and accelerated testing should both cover a minimum of 6 months' duration at the time of submission. Minimum time period of 12 months' duration should be covered by long-term data at the time the approval license is granted. The accelerated stability data may be waived if the long-term stability data reached to the claimed shelf-life are provided at the time of submission. Therefore, please perform long-term stability tests to meet the domestic requirements.



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