Environment, Science & Technology

Procedures for Exporting Human and Animal Specimens from China

A May 2003 report from Embassy Beijing

Responding to interest from U.S.-based scientists, the Embassy has confirmed the following Chinese government procedures regarding the exporting of human and animal specimens from China.

Human Specimens with Genetic Content

Anyone planning to export human specimens from which human genetic resources can be derived -- for example, whole blood -- must apply to the Human Genetic Resources Administration of China (HGRAC), a small specialized agency jointly established by the Ministry of Science and Technology (MOST) and Ministry of Health (MOH). These exports are subject to the “Interim Measures for the Administration of Human Genetic Resources,” promulgated by the State Council on June 10, 1998. In the case of an international collaborative project, the Chinese partner to the project is to apply to the HGRAC. Principal criteria in determining whether to approve the export include:

· Whether proper informed consent procedures have been followed in the collection of the samples;

· Whether the apportioning of ownership and intellectual property deriving from the samples is “fair;”

· Whether the research-related purpose of the export is clear; and

· Whether the recipient organization has the capability to conduct the intended research.

Significant paperwork is involved in documenting compliance with these criteria. Export of human genetic material without a permit can be punished by confiscation of the material and a fine. The agent can also be held legally responsible as an individual. Reviewing officials at HGRAC can also be punished for violating confidentiality.

Human Specimens without Genetic Content

Exporting specimens - for example, serum or urine -- from which human genetic resources CANNOT be derived requires approval from the Ministry of Health. The Chinese collaborating party of the joint project should apply to the Division of Health Technology Management in the Department of Science Technology and Education of the Ministry of Health, with the following documents:

A formal application letter (including purpose, name of specimens, place and time of export, and destination);
Detailed information on the specimen (including name, quantity, unit, package, safety and notice of opening for inspection);
A copy of the project approval document or the certificate for the project or work unit;
A copy of the contract (in Chinese and English) between the applicant and overseas collaborating institute or laboratory;
A copy of the contract between the applicant and domestic collaborating research institutes;
A copy of an approval letter from the Ethics Committee of the domestic collaborating research institute;
The formal research plan;
Informed consent forms and copies of signatures of the individuals being tested; and,
Other documents required by the approving authority.

The Ministry of Health says that applications should be made 30 days in advance of shipment of samples. The Department of Science Technology and Education should reply within 15 days after receiving the application.

The Ministry of Health point of contact is:

Ms. LIU Shuang

Division of Health Technology Management

Department of Education and S&T

Ministry of Health

Tel: (8610) 6879-2240

Fax: (8610) 6879-2234

Animal Specimens

The Division of Animal Quarantine in the Department of Animal and Plant Quarantine Supervision at the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) is responsible for animal specimens exported for research purposes. The Division will approve applications from Chinese collaborating parties “according to Chinese regulations and requirements of the importing country" -- for the United States, the U.S. Animal and Plant Health Inspection Service (APHIS). Once approved by the Division, the application will be forwarded to the Beijing Entry-Exit Inspection and Quarantine Bureau for detailed inspection of the shipment. The Beijing Entry-Exit Inspection and Quarantine Bureau is responsible for issuing the final approval document.

The point of contact at AQSIQ is:

Division of Animal Quarantine

Department of Animal and Plant Quarantine Supervision

General Administration of Quality Supervision, Inspection and Quarantine

Tel: (8610) 8226-1914/15/16