Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages) View the PDF document
Table of Contents
View the documentAbbreviations and acronyms used in this report
Open this folder and view contentsOpening ceremony
Open this folder and view contentsHerbal medicines
Open this folder and view contentsKeynote address
Open this folder and view contentsSafety of blood-derived products
Open this folder and view contentsAntimicrobial resistance - new initiatives
Open this folder and view contentsHarmonization I
Open this folder and view contentsHarmonization II
Close this folderProtection of trial subjects in clinical trials
View the documentCross-border movement of clinical trial subjects
View the documentCross-border movement of clinical trial subjects and regulatory communication
View the documentEthical principles and protection of trial subjects in China
View the documentRecommendations
Open this folder and view contentsRegulating biotechnology products
Open this folder and view contentsRegulatory challenges: health sector reform and drug regulatory capacity
Open this folder and view contentsAccess to drugs and vaccines I
Open this folder and view contentsAccess to drugs and vaccines II
Open this folder and view contentsCounterfeit pharmaceutical products
Open this folder and view contentsHomoeopathy
Open this folder and view contentsSafety monitoring
Open this folder and view contentsE-Commerce
Open this folder and view contentsCurrent topics
Open this folder and view contentsRegulatory challenges of new technologies
View the documentList of participants
View the documentBack cover
 

Ethical principles and protection of trial subjects in China

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.

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