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China: Germline / Embryonic

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Highly Regulated

Germline gene editing is allowed for research but implanting genetically engineered embryos or allowing them to develop past 14 days is prohibited.

Germline gene editing research is allowed, but establishing a pregnancy with a genetically engineered embryo is prohibited under multiple regulations. Gene editing requires approval by an ethics committee of a hospital or IVF clinic, but 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 2015, Chinese researchers were the first to edit human embryos using CRISPR, which some researchers thought was premature, and in 2017 Chinese researchers were first to use CRISPR to edit viable human embryos. 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 November 2018, scientist He Jiankui, who was then employed by the Southern University of Science and Technology in Shenzhen, China, used CRISPR-Cas9 to successfully edit the embryos of twin girls that were carried to term, in an effort to make them resistant to HIV. The Chinese government has since renounced the experiments, as did 122 Chinese scientists, and He is expected to face criminal charges for forged documents. China’s vice-minister of science and technology claimed he “blatantly violated China’s relevant laws and regulations”.

In 2019, a new draft of civil code was submitted to the National People’s Congress Standing Committee, which, if approved, would bring medical and scientific germline research into 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.

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). NMPA is the regulatory authority responsible for clinical trial oversight, approval, and inspections for drugs to be registered in China. 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. Two regulations (that have the legal status of ministerial guidelines, not laws) issued by the Ministry of Health in 2003, prohibit the manipulation of human embryos for reproduction. A regulation issued the same year by both the Ministry of Health and the Ministry of Science and Technology states that embryos created through genetic modification must be destroyed after 14 days of development and must not be implanted into the reproductive system of a human or any other animal. It is also prohibited to create IVF embryos for research only. IVF clinics and Assisted Reproductive Technology centers can lose their license if they violate these guidelines.

Products/Research

  • HIV: In 2018, He Jiankui, a Chinese scientist, received international condemnation after announcing that he had edited the germline of multiple embryos, two of which were carried to term, in an attempt to make the embryos resistant to HIV, the disease that causes AIDS. His actions spurred an international call in 2019 for a global moratorium on all clinical uses of germline editing.
  • Marfan Syndrome: Chinese scientists published research detailing use of CRISPR to correct a single mutant amino acid in 16 out of 18 attempts in human embryos, providing evidence for the corrective value of gene therapy for the FBN1 mutation that causes Marfan syndrome in both somatic (adult) and germline cells.

Regulatory Timeline

2020: Expected date of 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: 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: China’s science ministry bans the implantation of genetically modified embryos for reproductive purposes and prohibits altered embryos developing past 14 days. No punishments are attached to the regulation.

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, which state that embryos derived by genetic modification must not be allowed to develop for more than fourteen days and that once they have been used for research, they cannot be implanted into humans or other species.

 2001: Ministry of Health releases the Administrative Measures for Assisted Human Reproduction.

 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.

1988: Chinese Society of Medical Ethics of the Chinese Medical Association founded.

NGO Reaction

He Jiankui’s alteration of the DNA of human embryos that were carried to term has drawn international condemnation from scientists, researchers and organizations. Some scientists argue that germline gene editing is not only an unethical practice, but a potentially dangerous one that could lead to irreversible harm and a new era of eugenics.

Additional Resources

Click on a country (eg. Brazil, US) or region (eg. European Union) below to find which human / health products and processes are approved or in development and their regulatory status.

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Human / Health Gene Editing Index
Compare Regulatory Restrictions Country-to-Country

Gene editing regulations worldwide are evolving. The Gene Editing Index ratings below represent the current status of gene editing regulations and will be updated as new regulations are passed.

Colors and ratings guide
 

Regulation StatusRating
Determined: No Unique Regulations*10
Lightly Regulated8
Proposed: No Unique Regulations†6
Ongoing Research, Regulations In Development5
Highly Regulated4
Mostly Prohibited2
Limited Research, No Clear Regulations1
Prohibited0
Lightly Regulated: Gene and stem cell therapies regulated with minimal restrictions and requirements.
*Determined: No Unique Regulations: Gene and stem cell therapies regulated as phamaceuticals with no additional restrictions.

†Proposed: No Unique Regulations: Decrees under consideration for gene and stem cell therapies that would not require unique regulations beyond current restrictions on pharmaceuticals.

Therapeutic:
Gene editing of adult human cells, including gene therapy and stem cell therapy, that is used to treat and cure disease. Recent breakthroughs include CAR T-cell therapy, which uses patients’ own immune cells to treat their cancer.
Germline:
Gene editing of the human embryo or germline that results in genetic changes that are passed down to the next generation. This type of gene editing is the most controversial because changes are inherited and because it could theoretically be used to create “designer babies”. A Chinese scientist announced in 2018 that he had successfully edited twins that were brought to term. International backlash from the announcement has resulted in China and other countries working to clarify regulations on germline gene editing.

Rating by Country / Region
Click each column header and arrow to sort the countries / regions

Swipe right/left if all columns aren't visible

Country / RegionTherapeuticGermlineHuman Rating
Japan888
Brazil402
Canada402
Russia1057.5
Argentina513
Israel825
Australia402
China846
US402
Chile412.5
New Zealand402
Ukraine1057.5
Central America111
Paraguay111
Uruguay111
India402
UK444
Mexico804
EU402
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Gene editing is a set of techniques that can be used to precisely modify the DNA of almost any organism. It is being used for applications in human health, gene drives and agriculture. There are numerous gene-editing tools besides CRISPR-Cas 9, which gets most of the attention because it is a comparatively easy tool to use.

Gene editing does not usually involve transgenics – moving ‘foreign’ genes between species. It also refers to a specific technique in contrast to the general term GMO, which is scientifically ambiguous, as genetic modification is a process not a product. Most gene editing involves creating new products by deleting very small segments of DNA (sometimes in agriculture called Site-Directed Nuclease 1 or SDN-1 techniques), which can silence a gene or change a gene’s activity. Countries are evaluating whether or not to regulate this type of gene editing, since it is so similar to natural mutations. The GLP’s Gene Editing Index ratings reflect the regulatory status of SDN-1 techniques, which are the most liberally regulated and will generate most products in the near term.

To develop different products, gene editing can change larger segments of DNA or add DNA from other species (a form of transgenics sometimes in agriculture called SDN-2 or SDN-3 techniques). While many countries are not regulating or lightly regulating SDN-1 techniques, most are moving toward tightly regulating or even restricting SDN-2 and SDN-3.

For more background on the various gene editing SDN techniques, read background articles here and here.

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