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Technical Dossier Review of Drugs
New Drug Application (NDA)
Investigational New Drug Application(IND)
Application of Bridging Study Evaluation (BSE)
Active Pharmaceutical Ingredient (API)
Abbreviated New Drug Application (ANDA)
Drug Substance
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Postapproval Changes
Investigational New Drug Application(IND)
No.
Class
Title
41
Drug Substance
Should GMP certificates be required for the registration of an API?
42
Drug Substance
For active pharmaceutical ingredients or active pharmaceutical ingredients of drug products with licenses, shall the changes of technical documents be submitted to the TFDA?
43
Drug Substance
How long does it take for the DMF review? If the documentation is insufficient, what is the procedure for the submission of the supplement?
44
Drug Substance
What are the requirements of official documents to authenticate the drug substance that has been approved by regulatory agencies in an abbreviated review for a DMF application?
45
Drug Substance
What documents should be submitted for a DMF application?
46
Drug Substance
Can the foreign manufacturer of a drug substance directly submit a DMF application in Taiwan without agents?
47
Drug Substance
The DMF is divided into two parts – an open (or applicant’s) part and a closed (or restricted) part. Which one is required for a DMF submission? Is it necessary to submit two parts simultaneously? Can the manufacturer of the drug substance submit the closed part directly to the TFDA after the applicant submits the open part to the TFDA?
48
Drug Substance
Can different domestic agents submit DMF applications of the same drug substance from the same manufacturer?
49
Drug Substance
Can a drug substance from two or more manufacturers be submitted for a DMF application in one case, or separately?
50
Drug Substance
What documents should be submitted for the registration of a drug substance (API)?
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