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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)
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Investigational New Drug Application(IND)
No.
Class
Title
41
Drug Substance
When submitting a DMF or API registration application, if the specification of the drug substance is established based requirements listed in a compendial monograph, what should other requirements be noted?
42
Drug Substance
If an active pharmaceutical ingredient (API) has an amorphous crystal form, is it necessary to provide analysis results for its crystal form?
43
Drug Substance
If a drug substance is not included in monographing pharmacopeia, what are the requirements for the drug substance specification?
44
Drug Substance
According to the DMF technical information check list promulgated by TFDA, the drug substance process validation data may be replaced by the process validation protocol and a representative batch record. Is it required for the representative batch record to be from one of the process validation batches?
45
Drug Substance
Is it required to submit separate DMFs for the same drug substance but with different grades of particle sizes (different particle size distributions) ?
46
Drug Substance
If the submitting drug substance with two or more crystalline hydrate formulas, should DMF divide into different applications? If a drug substance has different solvated forms (hydrates), is it required to file a separate DMF for each of the hydrate?
47
Drug Substance
What types of administrative documents should be authenticated by R.O.C. (Taiwan) Foreign Affairs Offices for the application of an imported API registration?
48
Drug Substance
Should GMP certificates be required for the registration of an API?
49
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?
50
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?
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