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What is the authorisation procedure for conducting clinical trials in your jurisdiction?
Clinical trials of pharmaceuticals are governed Drug Registration Rules and the Pharmaceutical Good Clinical Practices issued by the China National Drug Administration (CNDA, formerly the China Food and Drug Administration). The Guidelines on Ethics Committee Reviews of Clinical Trials also apply. A clinical trial authorisation issued by the CNDA is required to conduct Phases I to III clinical trials seeking product approvals. However, as of 1 December 2015, the bioequivalent study for generic drugs need only be filed with the CNDA.
The procedure for securing a clinical trial authorisation consists of the following key steps:
- a formality review of the application by the CNDA Centre for Drug Evaluation;
- testing of samples by the relevant drug control institute to verify compliance with quality standards;
- a technical review by the Centre for Drug Evaluation, including an evaluation of the test report, clinical data and other supporting information; and
- administrative review and issuance of the clinical trial authorisation by the Centre for Drug Evaluation.
Before the commencement of the clinical trial, the approval of a qualified independent ethics committee must be obtained. Generally speaking, the ethics committee will review the protocol, informed consent form, investigator brochure and clinical trial authorisation to assess whether the rights and interests of study subjects can be fully protected.
How robust are the standard good clinical practices followed in your jurisdiction?
The conduct of clinical trials must adhere to the Pharmaceutical Good Clinical Practices and the protocols approved by the ethics committee of each study site. Investigators must take necessary measures to protect the safety of trial subjects and ensure the authenticity, accuracy and completeness of study results. On completion of a clinical trial, each investigator must produce, sign and date a summary report for submission to the sponsor.
Any serious adverse events must be promptly reported to the CNDA, the sponsor and the ethics committee. The sponsor and the investigator must promptly study serious adverse events and adopt necessary measures to protect the safety of trial subjects. The sponsor must also relay this report to any other investigators involved in the same study. In the case of any voluntary suspension of a clinical trial, the sponsor must notify the investigator, the ethics committee and the CNDA with reasons.
Since 2015, the CNDA has strengthened enforcement measures against widespread data integrity issues associated with clinical trials in China. To ensure authenticity and reliability of clinical study data, the CNDA ordered all applicants of pending drug registration submissions to conduct self-inspections. Companies that identify serious data integrity issues through self-inspections are encouraged to voluntarily withdraw their applications. The CNDA has also launched regular on-site clinical trial inspections over selected study sites, rejected new drug applications found to include data forgery and may blacklist the relevant applicants and sponsors.
Reporting, disclosure and consent
What are the reporting and disclosure requirements for the results of clinical trials?
A clinical trial authorisation holder must register all CNDA-approved registration studies on a drug clinical study registration platform (www.chinadrugtrials.org.cn) for public disclosure. Information to be disclosed includes:
- the drug name;
- information about the sponsor;
- information about the study (eg, objectives, design, phases of trials, grouping methods, end points and subject eligibility);
- information about the investigator; and
- the status of the study (ongoing or completed).
However, the detailed outcome of the study is not required for public disclosure on the platform.
What are the informed consent obligations with respect to clinical trial subjects?
Investigators must obtain an informed consent from each trial subject. The information in the informed consent form must include:
- the purpose, process and timeline of the trial;
- any anticipated benefits and risks to the subject; and
- the treatment and compensation that the subject may be entitled to in the event of trial-related injuries.
The informed consent form must be signed and dated by both the investigator and the individual trial subject or, if the subject is a child or incapacitated person, by his or her legal guardian.
What are the insurance requirements for clinical trials?
The sponsor of the trial must arrange insurance for the trial subjects to cover potential study-related losses.
What data protection issues should be considered when conducting clinical trials?
Individuals’ privacy is required for conducting studies of pharmaceutical products. For example, the Pharmaceutical Good Clinical Practices requires anonymity of subjects in the case report forms for clinical trials. Medical records in both physical and electronic format must be exclusively maintained and used by healthcare professionals at medical institutions and can be revealed to relevant third parties only under exceptional circumstances.
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