China

China

Chinese Clinical Trial Registry (ChiCTR)

Verified on September 9, 2021

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

Interventional

(Phase 1-4)
Chinese
English
Registration and Results Requirements
Registry Activity Legal Requirement Timing
ChiCTR Registration

Yes

Prior to enrollment
Results

Yes

Within one year of trial completion
CCRB Registration

No

Prior to enrollment
Results

No

NA
Drug Clinical Trial Registration and Information Disclosure Platform Registration

Yes

Prior to enrollment
Results

Yes

Within one year of trial completion

Registry Updates


  • 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"
  • September 2021: China Update - Upgrade of China’s Center for Drug Evaluation Website The Center for Drug Evaluation’s website will be upgraded and deployed from 19:00 on September 10, 2021 to 7:00 on September 13, 2021.  The clinical trial registration platform (also known as Drug Clinical Trial Registration and Information Disclosure Platform) will be temporarily closed, and the new version … Continue reading "September 2021: China Update"
  • December 2020: China Regulatory Update - China Drug Review and Approval Update According to the Announcement of the State Drug Administration on Implementation of the “Administrative Measures for Drug Registration” (No. 46 of 2020), to promote the drafting and formulation of related supporting normative documents and technical guidelines, deployment in the State Drug Administration Next, the Center for Drug Evaluation has … Continue reading "December 2020: China Regulatory Update"

References


  1. Login for ChiCTR. http://www.chictr.org.cn/enIndex.aspx. Published October 2005. Accessed November 13, 2018.
  2. WHO Data Set. World Health Organization. https://www.who.int/clinical-trials-registry-platform/network/who-data-set. Published May 2007. Accessed November 13, 2018.
  3. Which trial should be registered. ChiCTR. http://www.chictr.org.cn/questionen.aspx. Published October 2005. Accessed November 13, 2018.
  4. Results for public. ChiCTR. http://www.chictr.org.cn/uploads/documents/384799098e204749a21fa533028955f1.pdf. Published October 2005. Accessed November 13, 2018.