Gene therapy is allowed and clinical trials only require approval by an ethics committee of a hospital. Approval from national regulatory agencies is not required. Research ethics committees are responsible for ensuring compliance by performing ethical review of their institutions’ biomedical research activities involving human research participants. However, there is uncertainty about whether these regulations are subject to the force of law and penalties and enforcement mechanisms are unclear.
In 2018, a Chinese scientist altered the DNA of human embryos that were carried to term. The announcement sparked an international controversy, and as a result, the Chinese government says it will impose stricter human gene editing regulations
In 2019, a new draft of civil code was submitted by the National Health Commission, which, if approved, would bring medical and scientific germline research under civil legislation. The draft states that human clinical research, including gene editing, must get approval from China’s Ministry of Health (instead of only requiring approval from a hospital’s ethics committee). In addition, scientific and medical studies pertaining to human genes or embryos must “follow the relevant regulations and cannot harm people’s health, breach moral or ethical standards, or violate public interests”. The draft mentions fines and blacklists, but enforcement mechanisms are unclear. The civil code is expected to be adopted in March 2020. The regulations will not apply to preclinical research.
Medical research is regulated by the National Health and Family Planning Commission (NHFPC), formerly known as the Ministry of Health and the National Medical Products Administration (NMPA), formerly known as the China Food and Drug Administration (CFDA). The NMPA is the regulatory authority responsible for clinical trial oversight, approval, and inspections for drugs to be registered. However, national agencies tend only to give general guidance that is then interpreted by local organizations and committees, instead of developing and enforcing strict laws and regulations.
In 2017, the NMPA loosened their regulations for clinical trial approval. The Center for Drug Evaluation, a group within the NMPA, is responsible for processing new drug applications. Currently, if an institution in China wants to conduct clinical trials, it needs to be certified by health authorities. Under the new proposal, however, new sites would only need to register with the NMPA. In addition, the changes give the NMPA 60 working days to either reject or question a clinical trial application. Otherwise, the application is automatically considered approved.
Products/Research
- Cancer: There have been at least 11 clinical trials at various hospitals, beginning in 2015, to test CRISPR gene therapies for cancer treatment (including esophageal, nasal and head and neck) treatments in humans. Anhui Kedgene Biotechnology, a Chinese startup, is involved in most of the trials.
- Lung cancer: The first clinical trial of CRISPR. In 2016, researchers at the West China Hospital edited immune cells to treat lung cancer tumors.
- Head and neck cancer: The first gene therapy ever approved. Gendicine, developed by SiBiono GeneTech Co., was approved for the treatment of head and neck cancer, after a 2003 clinical trial.
- Melanoma: A gene therapy was approved in 2005 to treat melanoma in patients with recurring skin lesions.
- CAR-T therapies: Over 150 CAR T-cell therapy studies have been conducted. CAR T-cell therapies collect and use patients’ own immune cells to treat their cancer. One therapy, made by Innovative Cellular Therapeutics Co., is commercially available and clinical trials are underway for another CAR-T therapy to treat certain types of lymphoma.
- Relapsed cancer: In 2018, Chinese firm Nanjing Legend Biotech tested a CAR T-cell therapy treatment on relapsed multiple myeloma with promising results.
- HPV: In 2017, researchers at the First Affiliated Hospital of Sun Yat-Sen University targeted genes of the HPV virus to help patients avoid cervical cancer. This was the first trial to use CRISPR to edit cells while they are in the human body.
- HIV: In 2019, researchers completed the first published use of CRISPR to treat a disease in an adult. The treatment helped give the patient HIV resistance, but did not reach the level of a cure.
Regulatory Timeline
2020: Expected adoption of new civil code in China, which includes personal protections for human genes and stricter regulations for human gene editing.
2019: New civil code draft submitted that states studies involving human genes and embryos must follow the relevant regulations and cannot harm people’s health, breach moral or ethical standards or violate public interests.
2019: He Jiankui, who altered the DNA of human embryos that were carried to term, is censured by the Guangdong health ministry and fired from Southern University of Science and Technology.
2018: State Administration of Market Regulations (SAMR) established, which consolidates three separate ministries, the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) and the China Food and Drug Administration (CFDA).
2018: China’s National Health Commission orders an investigation into the work of He Jiankui.
2018: Chinese government orders temporary halt to human gene editing research in response to He Jiankui editing embryos that were carried to term.
2018: He Jiankui offers details about his work using CRISPR to edit human embryos at a gene-editing summit in Hong Kong and is roundly criticized.
2017: China first to use CRISPR on viable human embryos.
2016: National Health and Family Planning Commission issues Measures for the Ethical Review of Biomedical Research Involving Humans, which clarify the responsibilities of medical ethics committees and specify the basic scope of informed consent.
2015: Chinese researchers first to edit genes using CRISPR in a human embryo. A gene associated with a fatal blood disorder was modified, but the embryos were not implanted. The editing was not successful in most embryos in the experiment.
2008: Medical Ethics Expert Committee in the Ministry of Health created and Guidelines for Hospital Management Evaluation released.
2007: Ministry of Health releases Measures for the Ethical Review of Biomedical Research Involving Humans (For Trial Implementation).
2003: Chinese State Food and Drug Administration (CFDA; now called the National Medical Products Administration) publishes “Guidance for Human Gene Therapy Research and Its Products”, which outlines requirements for applications of gene therapy clinical study. The document also outlines requirements for quality controls and product efficacy and safety tests.
2003: State Food and Drug Administration (SFDA) issues the revised Norms on Quality Management of Drug Clinical Trials, requiring all medical institutions conducting clinical trials to be certified and establishing independent research ethics committees filed with the SFDA to “safeguard the rights and interests of all applicants for participation and participants in clinical trials”.
2003: Ministry of Health and the Ministry of Science and Technology jointly develop the Ethical Principles of Research of Human Embryonic Stem Cells.
2001: Ministry of Health releases the Administrative Measures for Assisted Human Reproduction.
1999: Guiding Principles for Human Gene Therapy Clinical Trials finalized.
1999: SFDA issues the Norms on Quality Management of Drug Clinical Trials.
1997: Minister of Health orders establishment of research ethics committees at medical research institutions.
1993: Chinese Ministry of Public Health releases “An Outline of Quality Controls for Clinical Studies of Human Somatic and Gene Therapy.”
1988: Chinese Society of Medical Ethics of the Chinese Medical Association founded.
NGO Reaction
The alteration of the DNA of human embryos that were carried to term has drawn international condemnation from scientists, researchers and organizations. Chinese researchers joined an international call in 2019 for a global moratorium on all clinical uses of germline editing. Worldwide, the scandal has initiated a re-evaluation of human gene editing laws.
Additional Resources
- Genetic Literacy Project’s FAQ on gene editing
- Library of Congress summary of China gene regulations includes detailed analysis of the country’s evolving biosafety laws and liabilities
- NIH ClinRegs: Aggregating clinical research regulations, China
- The Chinese Ethical Review System and its Compliance Mechanisms
- Chinese Clinical Trial Registry
