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SFDA Issues New Clinical Trial Guidelines

By Tommy Tang, GBI Analyst

On November 2, The State Food and Drug Administration (SFDA) promulgated the Guideline for Ethical Review of Drug Clinical Trials. The Guideline, which comprises of 9 chapters with 52 articles, was formulated in accordance with the Provisions for Drug Registration and the Good Clinical Practice (NYSE:GCP), and issued in order to strengthen the quality management of drug clinical trials and the protection of research participants as well as standardize and instruct the ethical review of the SFDA Ethics Committee during clinical trials.
 
The Guideline will have a major influence on drug clinical trials, which is essential in the new drug development and registration process. As mentioned in GCP rules, drug clinical trials should be scientific in research and rational in ethics. In 2003, the GCP launched by SFDA had a related statement regarding ethical review and the Ethics Committee’s responsibilities (mainly in Chapter 3: The protection of the rights and interests of research participants), but did not include operational processes and detailed guidelines. According to the latest version of the Chinese drug registration regulation, an approval letter from the Ethics Committee should be provided before conducting the clinical trials (See below in Article 37, SFDA Order 28).
 
 Article 37: Before conducting the clinical study, the applicant shall file with SFDA information such as the clinical study protocol, name of the principle investigator of the leading institution, participating institutions and investigators, approval letter from ethics committee, and the sample of the Informed Consent Form, also providing a copy to the PDA where the institutions are located and PDA where the application was filed.
-- Provisions for Drug Registration (SFDA Order 28)
 
This newly published guideline sets out clear requirements and regulations on major points of the ethics review, including its purpose, organization, management, procedures, methods, contents, tracking forms, and documentation management. The Committee will supervise the review with the authority to approve/reject a clinical trial application as well as terminate/suspend an ongoing clinical trial. The Committee is also responsible for tracking all approved clinical trials from start to end, in other word, supervising the entire process. In addition, the Committee functions individually, separated from the research organizations and other administration divisions. These will contribute to a healthier environment for drug clinical trials.
 
A primary goal of clinical trials is to ensure the safety and protection of the rights and benefits of volunteers. According to article 34 of the Guideline, there are seven emphasized key factors that should be considered by research organizations when seeking approval for clinical trials, including:
1. Readily available control measures for predictable potential risks
2. Tolerable risks and expected benefits for research participants
3. Fair and objective participant selection
4. Available Informed Consent Forms to ensure participants are well-informed
5. Adequate data and safety monitoring plan for pilot programs
6. Strict implementation of confidentiality for participants’ personal information
7. Special protection program/plan for vulnerable groups
 
With an increasing number of clinical trials being conducted in China, including the expansion of international multi-center trials, the SFDA is updating related drug regulations and making them more compatible with international standards. As this Guideline is being implemented, clinical trials in China are now not only being investigated by CDE (Center for Drug Evaluation) mainly for drug safety and efficacy, but also supervised more normally and strictly by the SFDA Ethics Committee.

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