Heavy! Detailed Rules for the Implementation of the Regulations on the Administration of Human Genetic Resources

In order to further implement the Regulations on the Management of Human Genetic Resources in the People's Republic of China (hereinafter referred to as the Regulations) and further improve the standardization of the management of human genetic resources in my country, the Ministry of Science and Technology has issued the Implementation Rules for the Regulations on the Management of Human Genetic Resources (hereinafter referred to as the Implementation Rules). Regarding the relevant issues of public concern in the Implementation Rules, the interpretation is as follows:

Question 1: The background and process of the formulation of the "Implementation Rules?

Answer: In order to strengthen the management of human genetic resources and promote the effective protection and rational use of human genetic resources, the Ministry of Science and Technology initiated the formulation of the Implementation Rules after the promulgation of the Regulations. After extensive consultation with relevant departments of the State Council, provincial science and technology administrative departments, After the opinions of relevant scientific research institutions, enterprises, experts, scholars and the public have been fully studied and absorbed, the "Implementation Rules" have been formed.

Question 2: What is the general idea of the Implementation Rules?

Answer: The "Implementation Rules" are based on the "the People's Republic of China Biosafety Law", "the People's Republic of China Administrative Licensing Law", "the People's Republic of China Administrative Punishment Law", "the People's Republic of China Science and Technology Progress Law" and other relevant laws, and are guided by problems and actual needs to implement the "Regulations." The first is to implement the "the People's Republic of China Biosafety Law", "Regulations" and other laws and regulations, administer according to law, perform duties with due diligence, and carry out scientific, rigorous and efficient management of human genetic resources. The second is to clarify the responsibilities of the central and local governments in the management of human genetic resources, and promote the establishment of an integrated supervision and management mechanism. The third is to clarify the management boundaries, deepen the reform of "release, management and service", strengthen the control of key links, and resolutely control the management and release under the premise of resolutely safeguarding national biosafety. The fourth is to realize the accessibility of the implementation of the system, improve procedural regulations in all aspects of administrative licensing, filing, and safety review, strengthen specific measures for supervision, inspection and administrative penalties, and ensure the efficient operation of human genetic resources management in accordance with laws and regulations.

Question 3: What are the optimization measures?

A: Deepen the reform of "release, management and service" and optimize the administrative licensing and filing requirements and procedures for human genetic resources activities.

One is to optimize the scope of administrative licensing and filing. Optimized the collection of human genetic resources, preservation, international scientific research cooperation administrative license, as well as international cooperation in clinical trial filing, information provided to the outside world or open the scope of the use of advance reports. For example, it is clear that the scope of human genetic resources information management is human gene, genome data and other information materials, excluding clinical data, image data, protein data and metabolic data; Refine the specific definition of foreign organizations, individuals and their establishment or actual control institutions; Add "human genetic resources collection for common diseases such as hypertension, diabetes, red-green blindness, hemophilia and other common diseases is not included in the management of important genetic families"; in order to obtain the marketing license of relevant drugs and medical devices in China, there is no need to apply for collection approval for clinical trials involving collection activities; for matters that meet the requirements of preservation license declaration, there is no need to apply for collection approval separately; the filing limit of international cooperative clinical trials for obtaining the marketing license of relevant drugs and medical devices in China will be expanded from clinical institutions to clinical medical and health institutions, or human genetic resources are collected in clinical medical and health institutions and tested, analyzed and processed by the domestic units designated by the clinical trial scheme of relevant drug and medical device marketing license, and the international cooperation approval meeting the above two conditions will be converted into international cooperation filing; the data and information generated by international scientific research cooperation that has obtained administrative license or completed filing are agreed to be used by both parties in the international cooperation agreement, there is no need for separate provisions such as prior reporting of information and submission of information backups. Through this series of combined provisions, we will earnestly fulfill the requirements of "letting go" and promote industry self-discipline.

The second is to strengthen the operability of the system. Standardize the procedures for the application, change, continuation and revocation of administrative approval and filing, refine the major changes and non-major changes in the approval of international cooperation, and simplify the change procedures for international multi-center clinical research.

The third is to implement the registration and reporting system for the management of human genetic resources. It is clear that the national survey of human genetic resources should be carried out every five years, and if necessary, it can be carried out according to actual needs. Strengthen the registration and active declaration system of important genetic resources, explore the establishment of a catalog management of important genetic resources, and discover important genetic families and human genetic resources in specific regions, and promptly make active declarations through the declaration and registration management information service platform. Establish an annual report and inspection system for preservation, and make it clear that the preservation situation of the previous year will be submitted to the Ministry of Science and Technology before January 31 each year. The Ministry of Science and Technology organizes various provincial science and technology administrative departments to conduct spot checks on the preservation activities of human genetic resources preservation units in the region every year. The two parties that have obtained the administrative license for international scientific research cooperation or completed the filing of international cooperative clinical trials shall jointly submit a report on the cooperative research to the Ministry of Science and Technology within six months after the expiration of the administrative license or filing.

Question 4: What are the specific provisions on the scope of the definition of foreign units that are of concern to the outside world?

Answer: The institutions established or actually controlled by overseas organizations or individuals as mentioned in these Regulations include the following situations:

(I) overseas organizations or individuals hold or indirectly hold more than 50% of the shares, equity, voting rights, property shares or other similar rights and interests of the institution;

(II) foreign organizations or individuals hold or indirectly hold less than 50% of the shares, equity, voting rights, property shares or other similar rights and interests of the institution, but their voting rights or other rights and interests are sufficient to dominate or exert significant influence on the decision-making and management of the institution;

(III) overseas organizations and individuals, through investment relationships, agreements or other arrangements, are sufficient to dominate or exert significant influence on the decision-making and management of the organization;

Other circumstances as prescribed by (IV) laws, administrative regulations and rules.

Question 5: What about the fast-track approval mechanism?

Answer: In response to major public health incidents and other emergencies, the Ministry of Science and Technology has established a rapid approval mechanism, and should speed up the processing of administrative license applications for human genetic resources involved in emergency response. For applications for administrative licensing of human genetic resources that are subject to rapid approval, the Ministry of Science and Technology shall, in accordance with the principles of unified command, efficient, rapid, and scientific approval, speed up the organization of the acceptance, review, and review of administrative licensing applications. The circumstances, procedures, time limits, requirements and other matters of rapid examination and approval shall be separately stipulated by the Ministry of Science and Technology.

Question 6: What are the provisions for supervision and inspection and administrative punishment?

Answer: On the basis of deepening the reform of "release to service", strengthen the supervision of human genetic resources activities, and realize the combination of strict supervision and promotion of innovation. The "Implementation Rules" provide for the entities and procedures of human genetic resources management supervision and inspection and administrative penalties. More detailed regulations. One is in terms of supervision and inspection. Differentiated and classified supervision mechanisms such as daily supervision and inspection, key supervision and inspection, and special supervision and inspection have been designed, and specific and clear provisions have been made for the implementation of the requirements of "two random and one open"; for the administrative coercion and evidence preservation that may be involved in the supervision and inspection process And other measures have been refined. The second is to establish and improve the administrative law enforcement mechanism in terms of administrative penalties, and specifically stipulate the hearing system, review and decision, and enforcement of administrative penalties, which not only meets the new requirements of the revision of the Administrative Punishment Law, but also strengthens the human genetic resources Legal responsibility for supervision.