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Technical Dossier Review of Drugs
New Drug Application (NDA)
Investigational New Drug Application(IND)
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Active Pharmaceutical Ingredient (API)
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Botanical drug
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Postapproval Changes
Investigational New Drug Application(IND)
No.
Class
Title
211
Botanical drug
How to design human pharmacokinetic (PK) development plans to support new drug application (NDA) of botanical drug when its active ingredient is identified?
212
Botanical drug
According to Chapter VI, section G of“Applicability of Combination Drug Regulations”published in 2016 US FDA Guidance for Industry “Botanical Drug Development”, is a botanical drug sourced from a single plant considered as a combination (due to different parts of a single plant) or not?
213
Botanical drug
If the claimed indication of botanical new drug is to add-on to other medication, what should be considered for nonclinical studies and from clinical/regulatory perspective?
214
Instruction Drugs
How to include the QR code for the imported drug products on the original carton to meet regulatory requirements?
215
Instruction Drugs
Is it allowed to apply for addition of tablet debossing patterns for the purpose of exportation for locally manufactured tablets already granted drug licenses?
216
Instruction Drugs
Is it necessary to apply for change for non-prescription drug products for dispensing in accordance with the format for labeling and package of OTC drugs according to the MOHW No. 1051402838 (announced on March 8, 2016)?
217
Instruction Drugs
All active ingredients of an instruction drug are listed in the "Guidelines on the Review of Instruction Drugs", but the contents of the active ingredients are not corresponded to this guideline. Can the post-approval change be submitted for the leaflet revision based on this guideline?
218
Instruction Drugs
What is the legal basis for the drugs containing active ingredients in line with "Guidelines on the Review of Instruction Drugs" following the regulations for generic drug registration?
219
Instruction Drugs
An instruction drug contains the active ingredient in line with “Guidelines on the Review of Instruction Drugs”. Is the document for registration submission of abovementioned instruction drugs required in CTD (common technical document) format? Is the content of the document required in accordance with “Regulations for Registration of Medicinal Products”?
220
Instruction Drugs
If an imported product that is regulated as a non-prescription drug in foreign countries, can it apply for a non-prescription drug in Taiwan? Which related regulations could be referred to?
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