The State Drug Administration issued the "Technical Guidelines for Accepting Data from Overseas Clinical Trials of Drugs"


Release time:

2018-07-11

In order to implement the Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices by the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council, and to strengthen the guidance and standardization of the work of accepting overseas clinical trial data of drugs, the State Drug Administration has organized and formulated "Technical Guidelines for Accepting Overseas Clinical Trial Data of Drugs" (hereinafter referred to as "Guiding Principles"). On July 10, the guidelines were officially released. The Guiding Principles clarify the scope of application, basic principles, integrity requirements, technical requirements for data submission and the degree of acceptance of overseas clinical trial data.

  Ensure that the data is true, complete, accurate and traceable

The overseas clinical trial data covered by the Guiding Principles include, but are not limited to, the clinical trial data of innovative drugs obtained overseas by the applicant through the simultaneous research and development of drugs at home and abroad. If the research and development of generic drugs abroad has complete and evaluable bioequivalence data, it can also be used for drug registration in China.

The "Guiding Principles" require that applicants should ensure that overseas clinical trial data are true, complete, accurate and traceable, which is a basic principle. The process of data generation shall comply with the relevant requirements of the International Technical Coordination Committee for Registration of Medicines for Human Use (ICH) Good Practice for Clinical Trials (GCP). The applicant shall ensure that the overseas clinical trial design is scientific, the clinical trial quality management system meets the requirements, and the statistical analysis of data is accurate and complete.

In view of the fact that the integrity of clinical trial data is the basic requirement for accepting registration applications, the Guiding Principles specify that products applying for registration in China should provide all clinical trial data outside China and should not selectively provide clinical trial data.

  Data submission rules

The Guiding Principles describe the requirements for different types of data submission. When submitting an application for drug registration, all kinds of clinical trials at home and abroad shall be sorted out and summarized in accordance with the requirements of the application materials of the measures for the Administration of Drug Registration to form a complete clinical trial data package. Submitted data should include biopharmaceutics, clinical pharmacology, efficacy and safety profile data. The Common Technical Document Format (CTD) submission is encouraged.

  Data quality determines acceptance

According to the quality of clinical trial data, the "Guiding Principles" divide the accepted clinical trial data into three cases: complete acceptance, partial acceptance and non-acceptance.

The conditions for full acceptance include that the overseas clinical trial data are true and reliable, and meet the requirements of ICH GCP and drug registration inspection; the overseas clinical study data support the evaluation of the effectiveness and safety of the target indication; and there are no racial sensitivity factors that affect the effectiveness and safety.

Partial acceptance is given if there are ethnically sensitive factors affecting the validity and/or safety of the data, and there is considerable uncertainty in the evaluation of the validity and safety of the data extrapolated to the Chinese population. If there are significant problems with the data, which do not fully support the evaluation of efficacy and safety for the target indication, it is considered unacceptable. In addition, applications for drug registration for critical diseases, rare diseases, pediatrics and lack of effective treatment can be conditionally accepted if they are "partially accepted.