Center For Drug Evaluation,Taiwan

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Regulations


● Drug Registration ● Clinical Trial

　　　The The information provided herein is merely an elucidation of the announcement. If there is any discrepancy, please refer to the Chinese regulations. The English version is only for reference.

Drug Registration

Issued Date	2005/01/07
Issued by	DOH
Ref. No	0930339211 (2005) 0980360474 (2009/09/14) (Latest amendment)
Subject	Drug Registration Guideline
Attachment	Drug Registration Guideline

Issued Date	2009/09/30
Issued by	DOH
Ref. No	0980363183
RE	To announce the “Notes of the Assessment of the API DMF ” and the “Checklist for Technical Document for the API DMF” and effected from October 1st, 2009
Attachment	● Notes of the Assessment of the API DMF (Draft) ● Checklist for Technical Document for the API DMF (Draft)

Issued Date	2001/06/28
Issued by	DOH
Ref. No	0900039753
RE	Immediate enforcement of revision of rules related to application for registration concerning Free Sales Certificate (FSC) of drugs in the country of origin and requirement of CPP of three advanced countries. The objective is to solidify the safety system of new drugs, and encourage domestic R&D of pharmaceuticals and elevate clinical trial standards to further promote biopharmaceutical industry in Taiwan.
Attachment	Immediate enforcement of revision of rules related to application for registration concerning Free Sales Certificate (FSC) of drugs in the country of origin and requirement of CPP of three advanced countries.

Issued Date	2009/09/03
Issued by	DOH
Ref. No	0980362092
RE	Officially implement of the amendment of Article 38-1 of the Guideline on Drug Review and Registration
Attachment	Final revision of Article 38-1 of the Guideline on Drug Review and Registration

Issued Date	2009/02/13
Issued by	DOH
Ref. No	0980303370
RE	The DOH issued an announcement on 13th February 2009 (Ref. No. 0980303366) to enforce the amendment to Article 22-1 of the Guideline on Drug Review and Approval.
Attachment	Amendment to Article 22-1 of the Guideline on Drug Review and Approval

Clinical Trial

Issued Date	2009/07/09
Issued by	DOH
Ref. No	0980325016
RE	To announce the “Guideline on Bridging Study – Ethnic Factors in the Acceptability of Foreign Clinical Data”
Attachment	GUIDELINE ON BRIDGING STUDY- ETHNIC FACTORS IN THE ACCEPTABILITY OF FOREIGN CLINICAL DATA

Issued Date	2005/01/06
Issued by	DOH
Ref. No	0930338513
RE	To announce the “Guideline for Good Clinical Practice”
Attachment	“Guideline for Good Clinical Practice”

Issued Date	007/05/30
Issued by	DOH
Ref. No	0960318173
RE	Please follow this announcement to report severe adverse drug reactions and adverse events in relation to clinical trials.
Attachment	Please follow this announcement to report severe adverse drug reactions and adverse events in relation to clinical trials.

Issued Date	2007/09/14
Issued by	DOH
Ref. No
RE	Appendix 8 of the Notes for Drug Clinical Trial Application
Attachment	“Appendix 8 of the Notes for Drug Clinical Trial Application”

Issued Date	2009/08/27
Issued by	DOH
Ref. No	0980262155
RE	Before the “Act Governing Human Bio-Bank (Draft)” passes the legislature, the institutional review boards (IRB) of all research institutes are advised to stop processing applications concerning bio-medical researches where this Draft is applicable. For the applications already approved, research institutes should ensure that those researches are executed in compliance with the spirit of this Draft. Handling situation should be reported to the DOH.
Attachment	“Act Governing Human Bio-Bank (Draft)”

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