Interim Measures For The Administration Of Human Genetic Resources

Interim Measures for the Administration of Human Genetic Resources
Promulgated by the General Office of the State Council upon the approval of the State Council on June 10, 1998
The Ministry of Science and Technology and The Ministry of Public Health of
The People’s Republic of China
Chapter One: General Provisions
Article 1 The interim Measures for the Administration of Human Genetic
resources (hereinafter referred to as the Measures) are enacted for the purpose of
efficiently protecting and rationally utilizing human genetic resources in the People’
s Republic of China, strengthening the research and development of human genes
and promoting international cooperation and exchange on the basis of equality and
mutual benefits.
Article 2 The term “human genetic resources” in the Measures refers to the
genetic materials such as human organs, tissues, cells, blood specimens, preparations
of any types or recombinant DNA constructs, which contain human genome, genes or
gene products as well as to the information related to such genetic materials.
Article 3 Whoever involved in such activities in China as sampling, collecting,
researching, developing, trading or exporting human genetic resources or taking such
resources outside the territory of the People’s Republic of China shall abide by the
Measures.
Article 4 The State adopts a reporting and registration system on important
pedigrees and genetic resources in specified regions. Any institution or individual
who discovers or holds important pedigrees and genetic resources in the specified
regions shall immediately report to the relevant departments. No institution or
individual may sample, collect, trade, export human genetic resources or take them
outside the territory of the People’s Republic of China, or provide them to other
countries in any form without permission.
Article 5 Where the human genetic resources and the relevant information or
data are classified as State scientific or technological secrets, the Rules for the
Protection of State Secrets in Science and Technology shall be observed.
Chapter Two: Administration
Article 6 The State adopts a unified review-and-approval system regulated at
different levels over human genetic resources.
Article 7 The administrative department of science and technology and the
administrative department of public health under the State Council shall be jointly in
charge of the administration of human genetic resources of China in a national scale
and shall jointly establish the Human Genetic Resources Administration of China
(hereinafter referred to as the HGRAC) to carry out routine duties.
Article 8 The HGRAC in initially placed under the administrative department of
science and technology under the State Council. Under the direction of the
administrative department of science and technology and the administrative
department of public health under the State Council, the HGRAC shall perform the
following responsibilities.
1)To draft the relevant rules and implementory documents, promulgate such
rules for entering into force upon approval and ensure the enforcement of the
Measures through co-ordination and supervision;
2)To be in charge of the registration and administration of the important
pedigrees and genetic resources in the specified regions;
3)To review and examine international collaborative projects involving human
genetic resources in China;
4)To review and approve applications for exportation of human genetic
resources, and thereafter to issue Export Permit for Human Genetic Materials
(hereinafter referred to as the Export Permit and