Taiwan_Final revision of Article 38-1 of the Guideline on Drug Review and Registration

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

 

DOH Official Letter

Recipient:    IRPMA

Date:     3rd September 2009

Ref. No:      0980362092

Attachment: Final revision of Article 38-1 of the Guideline on Drug Review and Registration

RE: Article 38-1 of the Guideline on Drug Review and Registration is officially implemented as stated in the DOH's announcement issued on 3rd September 2009 (Ref. No. 09800362080).  A copy of the final revision of this article is in the attachment for your reference.

 

Revision of Article 38-1 of the Guideline on Drug Review and Registration

Article 38-1

The requirement of CPP for drug review and registration shall be exempted, if the manufacturer of an NCE drug has conducted clinical trials in Taiwan during the drug development stage, and the following conditions are satisfied:

Phase III pivotal trials in parallel with other countries and Phase I clinical trials have been conducted in Taiwan; or alternatively, Phase II clinical trials and Phase III pivotal trials both in parallel with other countries have been conducted in Taiwan.  The following criteria also have to be met:

In principle, there should be at least 10 valid Taiwanese subjects for a Phase I clinical trial, such as PK study, PD study or dose finding study.

In principle, there should be at least 20 valid Taiwanese subjects for a phase II clinical trial.

In principle, there should be at least 80 valid Taiwanese subjects for a Phase III clinical trial, or more so as to sufficiently justify a similar trial result to that of other countries.

End-of-trial reports should be submitted to the central health competent authority for assessment and approval.

A post-approval Risk Management Plan should be submitted to the central health competent authority for assessment and approval.

Upon the central health competent authority's request, manufacturers are obliged to assist in the inspection of overseas clinical trials and to provide sufficient documents and information to justify that the clinical trials conducted overseas are in compliance with the Medical Act and the GCP Guideline in Taiwan.

It is up to the central health competent authority's judgment to decide whether the results of clinical trials that satisfy all the above-mentioned conditions are qualified for an exemption of, or a substitution for,  bridging studies.