China Stops Clinical Application of Gene Sequencing

A few days ago, the State Food and Drug Administration and the National Health and Family Planning Commission jointly issued a notice requiring that no medical institution should carry out clinical applications of gene sequencing before the relevant access standards and management regulations are promulgated. If the notice continues after the issuance, the local health administrative department shall investigate and deal with it in accordance with laws and regulations.

Among the various propaganda about gene sequencing, the most well-known is the movie star Angelina Jolie. Through genetic testing, she chose surgery to remove the breast to reduce the risk of breast cancer; Apple founder Stephen Jobs, who died in 2011, has cancer At that time, I also received whole gene sequencing. In recent years, gene sequencing has been widely used in high-end physical examination (such as health status evaluation, early detection of cancer), prenatal diagnosis (such as genetic disease prediction) and other fields due to the "celebrity effect" in recent years, and the price is expensive. Some medical examination projects that claim personal whole-genome sequencing cost as much as tens of thousands of yuan.

As early as November 2013, the personal DNA testing service launched by 23andMe, the most prestigious company in the field of personal DNA testing, was also suspended by the US Food and Drug Administration (FDA).

However, the joint notice of the two ministries and commissions pointed out that gene sequencing-related products and technologies, including prenatal genetic testing, belong to the frontier of contemporary technology research, involving ethics, privacy, and protection of human genetic resources, biosecurity, and medical institutions to carry out genetic diagnosis services Management, price, quality supervision and other issues. At present, products and technologies related to gene sequencing have evolved from laboratory research to clinical use, and relevant departments of the State Council attach great importance to this. In order to ensure the safety and effectiveness of the public's use of gene sequencing diagnostic products, the State Food and Drug Administration and the National Health and Family Planning Commission are organizing investigations and demonstrations by experts in related fields.

Therefore, as of the date of this notice, all gene sequencing products and technologies including prenatal genetic testing, such as disease prevention, diagnosis, monitoring, treatment monitoring, health status evaluation and genetic disease prediction, It is subject to approval and registration by the food and drug regulatory authorities and technical approval by the health and family planning administrative department before it can be applied. What has been applied must be stopped immediately.

With joint notice

Notice of the General Office of the General Administration of Food and Drug Administration of the General Office of the National Health and Family Planning Commission on Strengthening the Management of Clinical Use of Gene Sequencing Related Products and Technologies

Food and Drug Administration Office Machinery Management (2014) No. 25

Food and Drug Administrations, Health and Family Planning Commissions (Bureaus of Health) of various provinces, autonomous regions and municipalities directly under the Central Government, Food and Drug Administration and Health Bureau of Xinjiang Production and Construction Corps:

Gene sequencing related products and technologies, including prenatal genetic testing, belong to the category of contemporary cutting-edge products and technology research, involving ethics, privacy and protection of human genetic resources, biosecurity, and medical institutions to carry out genetic diagnosis service technology management, price, quality supervision, etc. problem. At present, products and technologies related to gene sequencing have evolved from laboratory research to clinical use, and relevant departments of the State Council attach great importance to this. In order to ensure the safety and effectiveness of the use of gene sequencing diagnostic products by the public, strengthen the management of clinical application of medical technology. After investigation and research by the Food and Drug Administration and the National Health and Family Planning Commission, and organizing experts in related fields to demonstrate, it is now time to strengthen the clinical use of gene sequencing related products and The technical management notice is as follows:

1. In accordance with the "Regulations for the Supervision and Administration of Medical Devices", "Administrative Measures for the Registration of Medical Devices", "Administrative Measures for the Registration of In Vitro Diagnostic Reagents (Trial)", etc., gene sequencing diagnostic products (including gene sequencers and related diagnostic reagents and software), Through in vitro testing of human samples, it is used for disease prevention, diagnosis, monitoring, treatment monitoring, health status evaluation and prediction of genetic diseases, etc. It meets the definition of medical devices and should be managed as a medical device and should be in accordance with the "Medical Devices" The Regulations on Supervision and Administration and relevant product registration requirements apply for product registration; medical device products that are not approved for registration shall not be produced, imported, sold or used.

2. As of the date of this notice, all medical technologies including prenatal genetic testing, including testing instruments, diagnostic reagents, and related medical software products, such as disease prevention, diagnosis, monitoring, treatment monitoring, The evaluation of health status and the prediction of hereditary diseases require the approval of the Food and Drug Supervision Department for registration, and the approval of technical approval by the Health and Family Planning Administration before they can be applied. What has been applied must be stopped immediately.

3. The above-mentioned related products should apply for product registration in accordance with the provisions of the "Regulations for the Supervision and Administration of Medical Devices", "Administrative Measures for the Registration of Medical Devices" and "Administrative Measures for the Registration of In Vitro Diagnostic Reagents (Trial)". Among them, gene sequencers and diagnostic software products used for clinical testing should be applied for registration in accordance with the relevant procedures and requirements of the "Administrative Measures for the Registration of Medical Devices"; relevant in vitro diagnostic reagents should be in accordance with Procedures and requirements to apply for registration. In order to apply for product registration to carry out clinical trials in medical institutions, it should meet the requirements of the "Regulations for Clinical Trials of Medical Devices" and related regulations. The Food and Drug Administration encourages and supports the development of innovative medical devices.

4. The National Health and Family Planning Commission is responsible for the clinical application management of gene sequencing technology. The pilot unit for clinical application of gene sequencing determined by the National Health and Family Planning Commission may try gene sequencing products in accordance with the relevant regulations on the clinical application management of medical technology, and do the verification and evaluation of the corresponding technology.

The health and family planning committees (bureaus of health) of various provinces, autonomous regions and municipalities directly under the Central Government should strengthen the management of gene sequencing technology. Before the relevant access standards and management regulations are issued, no medical institution can carry out clinical applications of gene sequencing. Those that have already been carried out must be stopped immediately. If the notice continues after the issuance, it shall be investigated and dealt with in accordance with the law and regulations, and the relevant situation shall be reported to the National Health and Family Planning Commission in a timely manner.

5. The Food and Drug Administration of each province, autonomous region and municipality directly under the Central Government shall strengthen the supervision of the quality of medical devices in the research, production, circulation and use of relevant products in accordance with their duties. For the existence of unregistered application of gene sequencing related products in clinical practice, the relevant units shall be supervised and implemented in accordance with the requirements of the notice. Those that should be stopped but continued to be carried out shall be investigated and dealt with in accordance with the "Regulations for the Supervision and Administration of Medical Devices" and related regulations, and the relevant situation shall be reported to the Food and Drug Administration in a timely manner.

General Office of the State Food and Drug Administration General Office of the National Health and Family Planning Commission

February 9, 2014

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