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 V2.0“, in order to ensure the authenticity of the applicant’s identity and the authenticity and validity of the registration information, the platform uses the real-name Ukey account in the “Applicant Window” column of the Drug Evaluation Center to log in, and supports account password login and certificate login at the same time. The platform supports the login of the “Applicant’s Window” account and the original platform (old system) account.

The user is required to link the old system account with the Applicant’s Window account (known as account docking), as per the given process. Once this process is complete, user can login only through the Applicant’s Window and the old system account will not support the login.

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 of the website will enter the trial operation stage after the deployment is completed.

This website upgrade has further expanded the scope of applicants’ online business processing, adding different columns like “eCTD Column”, “Guiding Principles”, “Information Disclosure” etc. The deployment structure has been further enhanced, and the electronic document submission of applicants has been encrypted and protected, and the overall security of the website has been improved with enhanced service capabilities.

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 researched and formulated the “Administrative Measures for the Disclosure of Drug Review and Approval Information“. It is now promulgated and will take effect on June 1, 2021.

July 2020: China Regulatory Update

In accordance with the relevant requirements of the 2019 version of the “Drug Administration Law” and the 2020 version of the “Drug Registration Management Measures”, combined with common problems in the use of the original registration platform, the system upgrade and functional transformation were initiated in early 2020. The new platform merges the “drug clinical trial registration and information disclosure platform” with the “chemical generic drug bioequivalence and clinical trial filing information platform”.

At the same time, in order to ensure the authenticity of the applicant’s identity and the authenticity and validity of the registration information, the new platform uses the real-name ukey account in the “Applicant Window” section of the Drug Evaluation Center website to log in.

On September 6, 2013, the China Food and Drug Administration (CFDA) announced that it has established a Registration and Information Disclosure Platform for Drug Clinical Studies (“Platform”) via the website of CFDA’s Center for Drug Evaluation (website: www.cde.org.cn).  CFDA requires all clinical studies being conducted in China and approved by CFDA, including Phase I, II, III & IV studies, bioequivalence and PK studies, to be registered on the Platform.

 

March 2020: China Regulatory Update

The Drug Registration Management Measures were published on March 30, 2020. These measures are declared by Order No. 27 of the State Administration of Market Supervision and Administration approved on January 15, 2020. These drug registration measures will come into force on July 01, 2020.

According to article 33, “The sponsor should register the drug clinical trial plan and other information on the drug clinical trial registration and information disclosure platform before launching the drug clinical trial. During the clinical trials of drugs, the sponsor should continue to update the registration information and register the results of the clinical trials of the drugs after the completion of the clinical trials of the drugs. The registration information is publicized on the platform, and the sponsor is responsible for the authenticity of the registration information of drug clinical trials. The specific requirements for drug clinical trial registration and information disclosure shall be formulated and published by the Drug Evaluation Center.”

Also as per article 116, the sponsor shall be ordered to make corrections within a time limit if the sponsor has failed to register on the drug clinical trial registration and information disclosure platform as required before conducting the drug clinical trial and/or the clinical trial results and other information were not registered after the completion of the clinical trial of the drug.

The platform mentioned here is the disclosure platform launched by the Drug Evaluation Center of the State Drug Administration i.e. Chinadrugtrials.org.cn. The role of the primary registry i.e. Chinese Clinical Trial Registry is not yet clear, in relation to the regulation.