Service Guidelines for Administrative License Matters Concerning the Examination and Approval of Sampling, Collection, Trade, Export and Exit of Chinese Human Genetic Resources
I. Scope of Application
The license applies to the regulation and administration of sampling, collection, trade, export, exit and other matters of Chinese human genetic resources conducted within the territory of China. Sampling applies to sampling activities involving human genetic resources within the territory of China, including human genetic resources of important genetic pedigrees and populations in specific regions; collection applies to collection activities of human genetic resources for the purpose of preservation or international cooperation; according to the provisions of relevant laws and regulations, it is prohibited to purchase and sell human genetic resources, but transfer of human genetic resources for the purpose of scientific research does not fall into Trade; export and exit applies to circumstances where human genetic resources are transferred abroad.
Sampling, collection, export and exit activities of human genetic resources for clinical diagnosis and treatment, blood (plasma) sampling and supply services, forensic authentication, investigation of crime, doping tests, funeral and other purposes alike are managed according to relevant laws and regulations of the State, and do not fall into the applicable scope of the license.
II. Project Information
(I) Project name: Examination and approval of sampling, collection, purchases and sales, export and exit of human genetic resources.
(II) Type of examination and approval: Administrative license.
(III) Project number: 03002
III. Handling Basis
1. Administrative License Law of the People’s Republic of China.
2. Interim Measures for the Administration of Human Genetic Resources.
3. Item 26 in the Attachment to Decision of the State Council on Establishing Administrative License for Items Indeed Necessary for Administrative Examination and Approval (Decree No. 412 of the State Council), implementing authority: Ministry of Science and Technology, Ministry of Health.
4. Decision of the State Council on the Sixth Round of Cancellation and Adjustment of Items for Administrative Examination and Approval (G.F. [2012] No. 52), examining and approving department after adjustment: Ministry of Science and Technology.
IV. Accepting Authority
Ministry of Science and Technology
V. Decision-making Authority
Ministry of Science and Technology
VI. Quantity Limitation
There is no quantity limitation.
VII. Handling Conditions
(1) Applicant conditions
Legal person institutes legally established within the territory of China.
(II) Examination and approval conditions
1. Sampling and collection of human genetic resources.
1.1. Applicants applying for carrying out sampling and collection activities of human genetic resources shall have or meet the following conditions:
(1) The applicant shall have a relevant department in charge of the management of human genetic resources and have established an appropriate management system;
(2) Obtain consent from the Ethics Committee after review;
(3) Have a format text of informed consent form for providers of human genetic resources;
(4) Have definite purpose of sampling or collection of human genetic resources;
(5) Have the personnel, sites, facilities and equipment required for the sampling or collection of human genetic resources;
(6) Have a reasonable plan and protocol for the sampling or collection of human genetic resources;
(7) Meet other conditions stipulated by laws and regulations.
1.2. Sampling, collection or study activities of human genetic resources involving the participation of foreign parties fall into the scope of international cooperation, which shall meet the following conditions in addition to the conditions listed in 1.1.
(1) The Chinese partner shall handle formalities to apply for approval;
(2) All cooperating parties have the foundation and capability to carry out relevant work;
(3) The purpose and protocol of cooperation are clear;
(4) The cooperation period is reasonable;
(5) The sources of human genetic resources are clear and legitimate;
(6) There is a draft of the contract text;
(7) Obtain consent from the Ethics Committee of all cooperating parties after review, and provide a format text of the informed consent form for providers of human genetic resources;
(8) The ownership of intellectual property rights is clear, and the sharing scheme is reasonable;
(9) There is no harm to the national security, national interests and public security of China.
1.3. Under any of the following circumstances, applications for carrying out sampling or collection activities of human genetic resources will not be approved:
(1) The applicant does not have any relevant department in charge of management of human genetic resources;
(2) The applicant has not established appropriate management systems;
(3) No consent has been obtained from the Ethics Committee;
(4) No format text of informed consent form for providers of human genetic resources is provided.
(5) The purpose of sampling or collection of human genetic resources is unclear or illegitimate;
(6) There are no personnel, sites, facilities and equipment required for the sampling or collection of human genetic resources;
(7) The plan and protocol for the sampling or collection of human genetic resources is unreasonable;
(8) Harms may be caused to the national security, national interests and public security of China;
(9) Other circumstances that shall not be approved according to the provisions of laws and regulations.
1.4. Under any of the following circumstances, sampling, collection or study activities of human genetic resources involving the participation of foreign parties will not be approved:
(1) The Chinese partner fails to handle formalities to apply for approval;
(2) The cooperating parties do not have the foundation and conditions to engage in relevant studies;
(3) There are lack of clear purpose and direction of cooperation;
(4) The cooperation period is unreasonable;
(5) The sources of human genetic resources are unclear or illegitimate;
(6) The ownership of intellectual property rights and the sharing arrangement are unclear or unreasonable.
2. Export and exit of human genetic resources.
2.1. Applicants applying for carrying out export and exit activities of human genetic resources shall have or meet the following conditions:
(1) The cooperating parties have the foundation and capability to carry out relevant studies;
(2) The purpose and protocol of cooperation are clear;
(3) The cooperation period is reasonable;
(4) The sources of human genetic resources are clear and legitimate;
(5) There is a draft of the contract text;
(6) Obtain consent from the Ethics Committee of all cooperating parties after review, and provide a format text of the informed consent form for providers of human genetic resources;
(7) The ownership of intellectual property rights is clear, and the sharing scheme is reasonable;
(8) There is no harm to the national security, national interests and public security of China.
(9) Meet other conditions stipulated by laws and regulations.
2.2. Under any of the following circumstances, applications for carrying out export and exit activities of human genetic resources will not be approved:
(1) The cooperating partners do not have the foundation and conditions to engage in relevant studies;
(2) There are lack of clear purpose and direction of cooperation;
(3) The cooperation period is unreasonable;
(4) There is no draft of contract text;
(5) No consent has been obtained from the Ethics Committee after review;
(6) No format text of the informed consent form for providers of human genetic resources is provided;
(7) The sources of human genetic resources are unclear or illegitimate;
(8) The ownership of intellectual property rights and the sharing arrangement are unclear or unreasonable;
(9) There may be possible harms to the national security, national interests and public security of China;
(10) Other circumstances that shall not be approved according to the provisions of laws and regulations.
2.3. Under special circumstances, if it is indeed necessary to temporarily provide human genetic resources for receivers outside China, an application form for export and exit of human genetic resources and other materials required by the examining and approving authority shall be filled out; after local competent departments or relevant departments under the State Council review and approve, the application will be reported to the Human Genetic Resources Administration of China (HGRAC), and after approval thereof, an export and exit certificate will be issued.
VII. Application Materials
(I) List of application materials
(II) Submission of application materials
The applicant shall submit electronic application materials through the online application platform, and Paper materials may be submitted through the window or by mail:
1. Link to the online application system:
http://www.cncbd.org.cn/TColumn/Detail/3428;
2. Submission through the window: Administrative examination and approval acceptance window of the Ministry of Science and Technology (address: Building 4, No. 16 Yard, Middle section of West Fourth Ring Road, Haidian District, Beijing, China National Center of Biotechnology Development of the Ministry of Science and Technology);
3. Submission by mail: Administrative examination and approval acceptance window of the Ministry of Science and Technology (address: Building 4, No. 16 Yard, Middle section of West Fourth Ring Road, Haidian District, Beijing, China National Center of Biotechnology Development of the Ministry of Science and Technology, postal code: 100039, tel: 010-********).
IX. Application Receiving
(I) Method of receiving
Electronic application materials may be received through the online application platform, while paper application materials may be received through the window or by mail:
1. Online receiving:
http://www.cncbd.org.cn/TColumn/Detail/3428;
2. Receiving through the window: Administrative examination and approval acceptance window of the Ministry of Science and Technology (address: Building 4, No. 16 Yard, Middle section of West Fourth Ring Road, Haidian District, Beijing, China National Center of Biotechnology Development of the Ministry of Science and Technology);
3. Receiving by mail: Administrative examination and approval acceptance window of the Ministry of Science and Technology (address: Building 4, No. 16 Yard, Middle section of West Fourth Ring Road, Haidian District, Beijing, China National Center of Biotechnology Development of the Ministry of Science and Technology, postal code: 100039, tel: 010-********).
(II) Business hours
Working days: 8:00—11:30, 13:30—17:00.
X. Handling Process
Schematic diagram for the application and handling process:
XI. Method of Handling
The administrative license is handled according to general procedures, including application, acceptance, technical evaluation, decision-making, document delivery, etc.
(I) Online application
The applicant may submit electronic application materials through the “sampling, collection, Trade, export and exit examination and approval of human genetic resources” online application form.
(II) Online pre-acceptance
After the HGRAC receives the electronic application materials submitted online by the applicant, it will complete review within 5 working days. If the application materials are complete and comply with the stipulated form, the applicant will be informed to print the paper materials; if the application materials are incomplete or fail to comply with the requirements, the applicant will be informed of all contents to be supplemented and corrected through the online application platform in writing once and for all.
(III) Submission of paper application materials
After the applicant prints the electronic application materials that have been pre-accepted online, the application will be reported to the relevant department under the State Council or local provincial competent department in charge of science and technology according to the affiliation relationship. After such department’s review and approval, the paper application materials will be submitted to the HGRAC.
(IV) Review and acceptance of paper materials
After the HGRAC receives paper application materials submitted to the applicant, it will complete type review within 5 working days. If the application materials are complete and comply with the stipulated form, the HGRAC will officially accept the application and issue an acceptance form. Application materials which are incomplete or fail to comply with the stipulated form will be returned to the applicant.
(V) Technical evaluation
The HGRAC selects experts from the human genetic resources management expert group for technical evaluation of the application project accepted, and form expert evaluation opinions.
(VI) Work meeting examination and approval
The HGRAC holds work meetings to review the expert evaluation opinions, and make a decision approving or disapproving the application.
(VI) Results publicizing
The HGRAC notifies the applicant in writing, send a copy to its administrative competent department, and publicize the examination and approval results on the website of the Ministry of Science and Technology.
(VIII) Certificate delivery
The applicant receives examination and approval letter at the administrative examination and approval acceptance window by virtue of the acceptance form, or the acceptance window will mail the examination and approval letter to the applicant.
(IX) Handling of export and exit certificate
For applications involving the export and exit of human genetic resources, the applicant shall fill out an application form for the export and exit of Chinese human genetic resources (see Annex 3 for the template) according to the sample exit plan approved by the HGRAC, and submit an informed consent form (duplicate) signed by the providers of genetic resources. After review by the HGRAC, an export and exit certificate for human genetic resource materials will be handled.
XII. Administrative License Certificates
(I) Examination and approval letter for the sampling, collection, Trade, export and exit of Chinese human genetic resources (see Annex 2 for the style).
(II) Export and exit certificate for human genetic resources (see Annex 4 for the style).
XIII. Time Limit for Examination and Approval
The HGRAC will issue the examination and approval letter within three months after issuing the acceptance form (including time of expert evaluation). If the time limit for examination and approval indeed needs to be extended under special circumstances. Upon approval by the person in charge of the administrative authority, the time limit may be extended by 10 working days, and the applicant shall be informed of the reason for such extension.
XIV. Result Delivery
After the administrative license decision is made, the applicant will be informed by means of online announcement and telephone notification within 10 working days, and the examination and approval letter may be delivered on the spot or mailed to the applicant.
XV. Examination and Approval Charges
The examination and approval matters are free of charge.
XVI. Rights and Obligations of the Applicant
(I) According to provisions of the Administrative License Law of the People’s Republic of China and Interim Measures for the Administration of Human Genetic Resources, the applicant enjoys the following rights in accordance with the law:
1. The applicant enjoys the right of statement and the right to defend itself for the administrative license implemented by the administrative authority; if its legitimate rights and interests are damaged by the administrative license illegally implemented by the administrative authority, the applicant has the right to demand compensation.
2. If the applicant holds objection to the examination and approval decision, it may apply to the Ministry of Science and Technology for administrative reconsideration within 60 days after receiving the notice, or may file a lawsuit to the People’s Court within 6 months after receiving the notice.
(II) According to provisions of the Administrative License Law of the People’s Republic of China and Interim Measures for the Administration of Human Genetic Resources, the applicant shall honestly submit relevant materials to the administrative authority and report the real situation when applying for administrative license, and be responsible for the authenticity of substantial contents of the application materials.
If the applicant commits fraud and other behaviors in the administration application process, the Ministry of Science and Technology will terminate its review of the application or cancel the examination and approval decision that has been made, inform its competent department in writing, and investigate its responsibilities according to the Administrative License Law and Interim Measures for the Administration of Human Genetic Resources depending of the severity.
XVII. Consulting Channels
(I) Consulting through the window: Administrative examination and approval acceptance window of the Ministry of Science and Technology (address: Building 4, No. 16 Yard, Middle section of West Fourth Ring Road, Haidian District, Beijing, China National Center of Biotechnology Development of the Ministry of Science and Technology);
(II) Online consulting:
http://appweblogic.most.gov.cn/gzwd/gzwd_jsjg.jsp；
(III) Consulting through letters: Science and Technology for Social Development Department of the Ministry of Science and Technology (address: B No. 15, Fuxing Road, Haidian District, Beijing, Science and Technology for Social Development Department of the Ministry of Science and Technology, postal code: 100862);
(IV) Consulting via email: sfs_zhc@most.cn;
(V) Consulting by phone: 010-********, 010-********.
XVIII. Channels for Supervision, Complaint and Reporting
(I) Complaining through the window: Department of Policy, Regulations and Supervision of the Ministry of Science and Technology (B No. 15, Fuxing Road, Haidian District, Beijing);
(II) Complaining by phone: Department of Policy, Regulations and Supervision of the Ministry of Science and Technology 010-********;
(III) Online complaining:
http://appweblogic.most.gov.cn/gzwd/gzwd_jsjg.js；
(IV) Complaining via email: zhengj@most.cn；
(V) Complaining through letters: Department of Policy, Regulations and Supervision of the Ministry of Science and Technology (B No. 15, Fuxing Road, Haidian District, Beijing; postal code: 100862).
XIX: Business Hours and Address
Business hours: Working days: 8:00-11:30, 13:30-17:00.
Address 1: China National Center of Biotechnology Development of the Ministry of Science and Technology (Building 4, No. 16 Yard, Middle section of West Fourth Ring Road, Haidian District, Beijing).
Bus route: Take Subway Line 1, come out from B exit at Wukesong Station, and then take bus Line 627, 634 or 568 to Jingouhe Bus Station.
Address 2: Science and Technology for Social Development Department of the Ministry of Science and Technology (Department of the Ministry of Science and Technology, B No. 15, Fuxing Road, Haidian District, Beijing)
Bus route: Take Subway Line 1, come out from Military Museum Station, walk 50 meters westward along Fuxing Road to the intersection of Fuxing Road and Liulinguan Road, and then walk 50 meters northward along Liulinguan Road to arrive at the destination on the west side of the road.
XX. Public Query
Since the date of acceptance, applicants may inquire the examination and approval status by phone (010-********) or through the online application system of the Ministry of Science and Technology.
Three months after the date of acceptance, applicants may inquire the result by phone (010-********) or on the official website of the Ministry of Science and Technology.
Annex 1:
Application number:
Application Form for Examination and Approval of Sampling, Collection, Trade, Export and Exit of Human Genetic Resources:
mm dd yyyy
Made by the Human Genetic Resources Administration of China
Filling Instructions
1. The applicant shall carefully read the Interim Measures for the Administration of Human Genetic Resources and relevant documents before filling out the application form.
2. Please formally, carefully and honestly fill out the application form item by item according to its format.
3. The application form shall be filled out in neat and clear handwriting, and the expression shall be clear and rigorous.
4. The competent department referred to in the application form means relevant department under the State Council, or the competent department in charge of science and technology in the province, autonomous region or municipality directly under the Central Government where the applicant is located.
5. The application form is made in one copy. After the institute and the competent department has reviewed and signed their opinions, the application form shall be submitted to the Human Genetic Resources Administration of China.
Address: Building 4, No. 16 Yard, Middle section of West Fourth Ring Road, Haidian District, Beijing, postal code: 100039
6. When you use any abbreviation in a foreign language for the first time, please give the full name in the original language.
I. Basic Information Table of the Project
II. Purpose and Necessity of the Work
III. Working Foundation and Conditions
IV. Work Plan
IV. Ownership of Intellectual Property Rights and Sharing Arrangement
VI. Plan Table for Sampling, Collection, Export and Exit of Human Genetic Resources
VII. Review Opinions
Annex 2:
G.K.Y.B.SH.Zi. [20XX] No. XX
Examination and Approval Letter on Sampling, Collection, Trade, Export and Exit of Human Genetic Resources
XXXX：
According to relevant provisions of the Interim Measures for the Administration of Human Genetic Resources and expert evaluation opinions, after review, our Office approves “XXXXXX” project applied for by your institute to carry out XXXX activities of human genetic resources. Our reply is as follows:
1. Samples we approve your institute to sample are: XXXX (sample name): XXXX (quantity), XXXX (specification). The time limit for the execution of sampling activities is from X (month) XXXX (year) to X (month) XXXX (year).
2. Samples we approve your institute to collect for the purpose of preservation are: XXXX (sample name): XXXX (quantity), XXXX (specification). The time limit for sample preservation is from X (month) XXXX (year) to X (month) XXXX (year).
3. Samples we approve your institute to carry out international cooperation on with XXXXX and collect during cooperation: XXXX (sample name): XXXX (quantity), XXXX (specification). The time limit for the execution of international cooperation is from X (month) XXXX (year) to X (month) XXXX (year).
4. Samples we approve your institute to take abroad are: XXXX (sample name): XXXX (quantity), XXXX (specification). The time limit for exit is from X (month) XXXX (year) to X (month) XXXX (year).
5. When providing human genetic resources for receivers outside China, you shall proceed export and exit certificate according to the provisions, and provide “Application Form for the Export and Exit of Chinese Human Genetic Resources”, a copy of the examination and approval letter and a copy of the informed consent form for this batch of samples.
Human Genetic Resources Administration of China
XX XX, XXXX
cc:
G.K.Y.B.SH.Zi. [20XX] No. XX
Examination and Approval Letter on Sampling, Collection, Trade, Export and Exit of Human Genetic Resources
XXXX：
According to relevant provisions of the Interim Measures for the Administration of Human Genetic Resources and expert evaluation opinions, after review, our Office disapproves “XXXXXX” project applied for by your institute to carry out XXXX activities of human genetic resources. The reasons are as follows:
1.
2.
3.
If the applicant holds objection to the above decision, it may apply to the Ministry of Science and Technology for administrative reconsideration within 60 days after receiving the notice, or may file a lawsuit to the people’s court within 6 months after receiving the notice.
Human Genetic Resources Administration of China
XX XX, XXXX
cc:
Annex 3：
Application Form for Export and Exit of Human Genetic Resource Materials
No.:
Annex 4:
Certificate for Export and Exit of Human Genetic Resources
No.:
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