Preclinical and Clinical Trial Requirements
The essential requirements for conducting preclinical and clinical trials in China. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased here for USD 99.
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
No. According to the Technical Guidelines Governing Acceptance of Drug Clinical Data from Foreign Studies issued by NMPA on 20 July 2018, and Technical Guidelines Governing Acceptance of Medical Device Clinical Data from Foreign Studies issued by NMPA on 20 January 2018, NMPA accepts foreign clinical data if they meet certain technical and regulatory requirements.
2. How are clinical trials funded?
Most clinical trials are funded by pharmaceutical companies. Charity organizations and governmental institutions may also be the source of fund for some clinical trials.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
If the data obtained from the preclinical study will be used for the application of drug marketing approval, such preclinical study must be conducted in accordance with the GLP, according to which, the preclinical trial protocol should be approved by the project manager of the sponsor.
Clinical trials for drugs must be conducted in accordance with the GCP that sets for the requirements for the preparation of a trial, protection of the subjects, enactment of the trial protocol, roles and responsibilities of the primary investigator and sponsor, quality control and some other matters related to a clinical trial. The clinical trial protocol must be approved by the ethics committee of the study site.
Clinical trials for medical devices must be conducted in accordance with the GCP for Medical Devices, which sets for the requirements for the design, implementation and inspection of the clinical trial protocol, and collection, record, analysis and report of the trial data. The clinical trial protocol must be approved by the ethics committee of the trial site.
4. What are the requirements for consent by participants in clinical trials?
The trial site must obtain an informed consent from the trial subjects, which must include the following information: (1) purpose, process of the trial; (2) potential benefits and risks to the subject; (3) alternative treatment methods; and (4) rights and obligations of the subject. The informed consent form must be signed and dated by the investigator and the trial subject.
5. May participants in clinical trials be compensated?
In addition to the injury-related compensation (please refer to Question 6 below), PRC laws do not specify whether the subjects participating in the clinical trial are entitled to other payments. In practice, the travel expenses and loss of earnings of the subjects may be reimbursed by the sponsors in some clinical trials.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
According to the GCP for Drugs and the GCP for Medical Devices, the sponsor of a clinical trial must provide insurance for the trial subjects and assume the treatment expenses and compensation that the subjects may be entitled to in the event of the trial-related injuries or death.
The trial subject may also take legal actions against the trial site (if there is malpractice of investigators or nurses) or the sponsors (if there is quality issue of drugs).