China

China

Drug Clinical Trial Registration and Information Disclosure Platform (ChinaDrugTrials.org.cn)

Verified on March 10, 2023

China has a clinical trials registry, the Chinese Clinical Trial Registry (ChiCTR). It is a World Health Organization (WHO) recognized primary registry. It has a provision for both protocol registration and results posting. Additionally, as per the administrative measures for drug registration, protocol registration and results posting on Drug Clinical Trial Registration and Information Disclosure Platform (ChinaDrugTrials.org.cn) is a mandatory requirement, which is managed by the Drug Evaluation Center of China.

Registries at a Glance
Registry PHUSE Categorization Information to be Entered By Route of Data in Registry Study Type Language
ChiCTR Mandatory National Database (includes Ethics Requirement) Sponsor Through a dedicated registration platform (process independent from clinical trial application)

Interventional

(Phase 1-4);

Observational

Chinese
English
CCRB Mandatory National Database (includes Ethics Requirement) Sponsor Through a dedicated registration platform (process independent from clinical trial application)

Interventional

(Phase 1-4);

Observational

Chinese
English
Drug Clinical Trial Registration and Information Disclosure Platform (ChinaDrugTrials.org.cn) Mandatory National Database (includes Ethics Requirement) Sponsor Through a dedicated registration platform (process independent from clinical trial application)

Interventional

(Phase 1-4)
Chinese
English
ITMCTR Additional National Registry/Database (may be mandatory) Sponsor Through a dedicated registration platform (process independent from clinical trial application)

Interventional

(Phase 1-4);

Observational

Chinese
English
Registration and Results Requirements
Registry Activity Legal Requirement Timing
ChiCTR Registration

No

Prior to enrollment
Results

No

Within one year of trial completion
CCRB Registration

No

Prior to enrollment
Results

No

NA
Drug Clinical Trial Registration and Information Disclosure Platform (ChinaDrugTrials.org.cn) Registration

Yes

Prior to enrollment
Results

Yes

Within one year of trial completion
ITMCTR Registration

No

Prior to enrollment
Results

No

NA

Registry Updates


  • March 2023: China/WHO Registry Update - On 3 March 2023, the International Traditional Medicine Clinical Trial Registry (ITMCTR) was added to the Primary Registries Network of the International Clinical Trials Registry Platform (ICTRP) by the World Health Organization (WHO). It is the first cross-regional clinical trial registry that targets traditional medicine, in the WHO ICTRP registry network. The ITMCTR is a … Continue reading "March 2023: China/WHO Registry Update"
  • July 2022: China Registry Update - Suspension of Supplementary Registration From July 05, 2022, the Chinese Clinical Trial Registry (ChiCTR) has suspended supplementary registration of Clinical Trials. Supplementary registration is defined as the registration done after the first case of candidate is recruited. There have been no other changes made to the information available for supplementary registrations on the ChiCTR website.
  • September 2021: China Update - After the upgrade to Center for Drug Evaluation’s website on September 13, 2021, the “Applicant’s Window” login for the platform (also known as Drug Clinical Trial Registration and Information Disclosure Platform) is now available along with the old system account login. As mentioned in the “Instructions for Drug Clinical Trial Registration and Information Disclosure Platform … Continue reading "September 2021: China Update"

References


  1.  Login for Drug Clinical Trial Registration and Information Disclosure Platform.            http://www.chinadrugtrials.org.cn/common.login.dhtml Published November 1, 2012. Accessed June 2021.
  2. Frequently asked questions. http://www.chinadrugtrials.org.cn/helpLink.html. Published November 1, 2012. Accessed June 2021.
  3.  Module for BE trials filing. http://www.chinadrugtrials.org.cn/common.login.dhtml. Published November 1, 2012. Accessed June 2021.