Center for Drug Evaluation, Taiwan

FAQ

Drugs

Drugs

	No.		Class		Title
	211		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?
	212		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?
	213		Instruction Drugs		How to include the QR code for the imported drug products on the original carton to meet regulatory requirements?
	214		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?
	215		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)?
	216		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?
	217		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?
	218		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”?
	219		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?
	220		Application of Bridging Study Evaluation (BSE)		What is the implication of bridging study waiver?

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