FAQ
Drugs

What information is required on the package inserts of a generic drug?

刊登日期:2023-09-17  |  點閱次數 : 1832 次 

According to the Article 20 of the ”Regulations for Registration of Medicinal Products”. For generic drugs under pharmacovigilance, the package inserts should follow that of the first approved drug. For the registration or the changes in package inserts of generic drugs not under pharmacovigilance, the package inserts should follow the approved drug of the same active ingredient, same dosage form, same contents and same indication. The supplemented information on product characteristics and drug safety also can submit scientific evidence. It is not limited to those who have supplemented information on product characteristics and drug safety, and submitted scientific evidence for the contents of the supplement. The central health competent authority may ask for revising the package inserts if it is necessary.

 

(中文版)


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