When applying the drug registration for a drug product, which contains the same active ingredient but different hydrate form of drug substance compared to the marketed drug product in Taiwan, is the submission for ANDA acceptable? If the salt form of the drug substance is different, is the submission for ANDA acceptable?

刊登日期:2019-11-13  |  點閱次數 : 1629 次 

For different hydrate form :
It is necessary to provide relevant data to demonstrate that the difference of hydrate form does not affect the quality, safety and efficacy of the drug product. In addition, the unit dose of active ingredient should be identical. Then the submission of ANDA is acceptable.

For different salt form :
Whatever the difference of salt form, it’s deemed as different ingredient. In principle, the submission for ANDA is not acceptable and the submission of NDA is recommended.



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