The National Health and Family Planning Commission (the “NHFPC”) and the China Food and Drug Administration (the “CFDA”) recently jointly published the Administration Measures for the Research (for Trial Implementation) (the “Administration Measures”), which became effective on 20 July 2015.
The Administration Measures state that the Research (the “Research”) must comply with the principles of science, standardization, openness, ethics, and sufficient protection of the rights of research subjects. The Administration Measures also stipulate the qualifications and duties of the Research institutions, the review and record filing mechanism of the Research projects, the regulatory measures for the Research, and the protection of the rights of the Research subjects. Meanwhile, upon the promulgation of the Administration Measures, technologies related to stem cell treatment will no longer be regulated as class III medical technologies. It is worth noticing that Research accomplished under the Administration Measures cannot directly enter into clinical application.
Clarifying the duties and conditions of the Research institutions
Under the Administration Measures, the medical institutions conducting the Research (the “Institutions”) are the Research institutions. They are responsible for the quality management of stem cell reagents and clinical research. The responsibilities and duties that must be performed by the Institutions during the Research include initial review, registration/record filing, supervision of the process, quality management and risk management throughout the full process of the preparation of stem cell reagents and clinical research. In the event that an Institution fails to effectively fulfill its duties, the regulatory authorities may suspend the stem cell clinical research project, require rectification within a time limit, or circulate a notice of criticism, among other penalties pursuant to law.
An Institution must: be a Grade III, Level A hospital with diagnostic and treatment specialties corresponding to the Research; lawfully acquire the relevant professional qualifications for a pharmaceutical clinical trial institution; possess comprehensive medical treatment, teaching and scientific research capacities with legal, stable and sufficient research funds; and have a quality control mechanism, persons with the relevant qualifications in charge of the project, authorized reagent quality personnel and research personnel, academic committee and ethics committee mechanisms, and measures for preventing risks and handling adverse reactions and events.
Establishing the initial review, record filing mechanism and the research reporting system of projects
The Administration Measures set out that the clinical research of stem cells shall comply with the requirements of Good Clinical Practices. In addition, the Research must have a sufficient scientific basis and the disease prevention or treatment results must exceed the results from current measures or they must be able to be applied to diseases without current effective intervention measures, or diseases which threaten lives and severely affect the quality of life, or major medical and health care demands.
The Administration Measures establish the project initial review and record filing mechanism. The Institution’s academic committee is responsible for conducting a scientific review of record filing materials of the Research application, while the Institution’s ethics committee conducts an independent ethical review of the project. The principal personnel of the Institution will review those projects which have already passed the above reviews. A project that has been set up must be filed with China’s information system for medical research registration and record filing. The provincial health administration and the food and drug administration will jointly review the project materials and file with the NHFPC and the CFDA. After the research plan has been reviewed and filed for record, the Institution must supervise the researchers so that the researchers strictly comply with the research plan during the clinic research project. The original records of all materials must have electronic copies and must be kept for 30 years after the completion of the clinic research.
Meanwhile, the Administration Measures establish the research reporting mechanism, which requires Institutions to promptly report to the national and provincial health administration and the food and drug administration in cases of severe adverse reactions, errors or accidents. Moreover, the Administration Measures also contain handling and rectification measures. In addition, the Administration Measures also provide that for Research that has been filed for record, any research progress must be reported in accordance with the annual report. The Research outcomes must be reported upon the completion of each stage of the Research.
Respect and protect the rights of the research subjects
The Administration Measures set forth that to effectively protect the rights of the research subjects, the Institution shall establish a sound mechanism to effectively control and manage risks. For high-risk projects, effective measures must be taken for key supervision and administration responsibilities. Third-party insurance shall also be purchased to cover treatment costs and the corresponding economic compensation for damages or death to research subjects related to the Research.
To protect the research subjects’ right of informed consent, the Administration Measures stipulate that the research personnel of the Research must perform the obligation to inform the donors and the research subjects about the purpose, significance, content, the expected benefits, and the potential risks of the Research that they will participate in with plain, articulate and accurate language. The informed consent letter must be signed under the signatory’s free will. If a severe adverse event occurs to a research subject during the Research process, research personnel must immediately suspend the clinical research and render prompt and appropriate treatment to the research subject.
The Administration Measures are China’s first normative document on administrating stem cell clinical research. Its promulgation is of great significance to the promotion of the sound and orderly development of such research, and to promotion of sufficient and effective protection of research subjects.