Dr Guowei Sang, China

The State Drug Administration (SDA) was established in 1998, directly under the State Council, to improve the regulation of pharmaceutical products and medical devices, including the regulation of clinical trials and the protection of trial subjects in China.

On 1 December 2001, the newly revised Drug Administration Law was enacted in order to:

• ensure the protection of the rights, safety and welfare of human subjects;

• conform with internationally recognized ethical standards and scientific principles for clinical trials;

• ensure the clinical trial process is standardized and the results are scientific and credible;

• ensure that clinical trials of all drugs, including biotechnology products and traditional Chinese medicines, and in all phases, including human bioavailability or bioequivalence studies, are performed according to Chinese GCP.

Ethics committee approval and informed consent are measures used to ensure the protection of trial subjects.

SDA is responsible for drug administration nationwide. No clinical trials can be conducted unless all the related data have been submitted to the SDA for approval. In China, all clinical trials must follow Chinese GCP. The Department of Drug Registration and the Department of Drug Safety and Inspection are within the structure of the SDA and are jointly responsible for the evaluation and inspection of clinical trials of new drugs. Penalties are imposed for illegal activities in drug research and application.

Since 1992, China has recognized that GCP is an international ethical and scientific standard for the design, conduct, recording and reporting of clinical trials that involve human subjects. An internationally accepted GCP is also important to China, since it allows participation in international cooperation in medical and pharmaceutical science, technology and trade. Therefore, the Chinese GCP is based on the International Guidelines for Biomedical Research Involving Human Subjects, prepared by the Council of International Organizations in Medical Science and WHO. The Chinese GCP was adopted by the SDA and enacted in September 1999. In 2000, a number of GCP training and teaching activities were organized and related materials published.

While the Drug Administration Law and the Chinese GCP have improved clinical practice in China and led to greater protection of trial subjects’ rights, benefits, and safety, special guidelines are needed for clinical trials of biotechnology products and vaccine, taking into account their specific characteristics. It is also strongly recommended that a general training programme be conducted for medical doctors, manufacturers and the public on the ethical principles and protection of subjects in clinical trials, so that clinical trials in China will achieve an internationally recognized standard.