Legal & Regulatory > China > Preclinical and Clinical Trial Requirements: China

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 GBP 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 the 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 will accept 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?

DRUGS

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 forth the requirements for the preparation of a trial, protection of the participants in the trial, 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 protocols must be approved by the ethics committee of the study site.

MEDICAL DEVICE

Clinical trials for medical devices must be conducted in accordance with the GCP for Medical Devices, which sets out 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 and process of the trial; (2) potential benefits and risks to the participant; (3) alternative treatment methods; and (4) rights and obligations of the participant. The informed consent form must be signed and dated by the investigator and the trial participant.

According to the latest China GCP for Drugs effective from July 1, 2020, the informed consent form and relevant materials provided to the trial participant shall contain following basic elements:

1. Overview of the clinical trial.
2. Purposes of the clinical trial.
3. The likelihood of receiving trial therapy treatment and random grouping.
4. Steps to be followed by the trial participant, including traumatic medical procedures.
5. Obligations of the trial participant.
6. Experimental elements of the clinical trials.
7. Risks or inconvenience that the trial participant is likely to subject to, especially when there is a risk of affecting the embryo, fetus or breastfed baby.
8. The anticipated benefits of the trial and the possibility of no benefits.
9. Alternative medication and therapies, and their important potential benefits and risks.
10. Compensation and treatment available for trial participants in the event of a trial-related damage.
11. Compensation available for trial participants.
12. The expected cost of participating in clinical trials for trial participants.
13. The trial participant’s participation is voluntary, and refusal to participate or discontinuation with the trial at any stage will involve no discrimination or retaliation, and the medical treatment and benefits that such trial participant is entitled to will not be compromised.
14. Without violating confidentiality obligations and applicable laws and regulations, inspectors, auditors, ethics committee and governmental officials of the drug regulatory authorities may examine the original medical records of trial participants, in order to verify the process and data of clinical trials.
15. The confidential treatment and non-public use of trial participants’ identification records. Even if clinical trial results are published, the trial participant’s identity information shall remain confidential.
16. In the event of any information that may affect the trial participant’s continued participation in the trial, the trial participants or their guardian shall be timely notified.
17. The investigators and ethics committee that trial participants can turn to and their contact information, in the event of any trial-related information or issues regarding the trial participant’s rights and benefits, or upon the occurrence of trial-related damages.
18. The circumstances and reasons why trial participants may be withdrawn from the trial.
19. The expected time period of the trial participant’s participation in the trial.
20. The estimated number of trial participant participating in the trial.

According to the current China GCP for Medical Devices effective from June 1, 2016, the informed consent form shall contain following basic elements:

1. Name and other basic information of the principal investigator.
2. Name of the clinical trial site.
3. Subject, purpose, methods and contents of the clinical trials.
4. Procedures and time periods of the clinical trials.
5. Source of funds for trials and potential conflict of interests.
6. Anticipated benefits and known or expected risks and adverse events that may happen to trial participants.
7. The alternative treatment available to trial participants and potential benefits and risks for the same.
8. The likelihood that the trial participants may be randomly assigned to any trial group, if needed.
9. The trial participant’s participation is voluntary, and refusal to participate or discontinuation with the trial at any stage will involve no discrimination or retaliation, and the medical treatment and benefits that such trial participant is entitled to will not be compromised.
10. The personal information of trial participants is kept confidential, but the ethics committee, NMPA and its local agencies, National Health Commission and its local agencies and sponsors of the trial may access such personal information to the extent necessary for carrying out their respective work, subject to prescribed procedures.
11. Trial participant’s entitlement to medical treatment and economic compensation in the event of trial related injury.
12. The trial participant may have access to information and materials that are related to him or her at any time during the trial.
13. (Free diagnosis and other relevant subsidies that the trial participant is entitled to during the trial.

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 participants participating in the clinical trials are entitled to other payments. In practice, the travel expenses and loss of earnings of the participants 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 participants and assume the treatment expenses and compensation that the participants may be entitled to in the event of the trial-related injuries or death.

The trial participant may also take legal action against the trial site (if there is malpractice of investigators or nurses) or the sponsors (if there is quality issue of drugs).