FAQ
Drugs

When will the e-submission system be fully implemented for the new drug registrations and clinical trial applications?

刊登日期:2021-10-14  |  點閱次數 : 1229 次 

According to the announcement of TFDA on June 6, 2019, the e-submission system would be fully implemented for the drug license extension, license cancelation and administrative changes since January 1, 2020. The other types of submission are still under planning.

According to the announcement of TFDA (No. 1101404982) on May 24, 2021, the e-submission of clinical trials would be applied for both standard review and fast track review since July 1, 2021. Both the original route of submission and e-submission are applicable.

(中文版)


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