Center for Drug Evaluation, Taiwan

FAQ

Drugs

Drugs

	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)?

Page: 5/24 ‧ Total: 232

1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 |

Drugs Medical Devices Consultation Services Health Technology Assessment International Cooperation