Clinical trials in China
are closely regulated by the government, and may only involve hospitals
and physicians that are endorsed by the government. Clinical trials
must be conducted in accordance with Good Clinical Practice. Regulations
concerning clinical trials are the Drug Administration Law of 2001
and the Drug Registration Regulation of 2002.
The State Drug Administration (SDA) is the competent national authority
for review and approval of clinical research. Applications for clinical
trials are subject to strict review, which is a relatively long process;
accelerated review may be possible for clinical trials of new drugs
which treat difficult, serious or life-threatening diseases, and for
clinical trials of a drug which is the same kind as an already approved
drug.
Ethics committee approval must also be obtained, and the written opinion
submitted to the SDA before completion of the review of the clinical
trial application.
 Health
Care System |
| Only a minority of
China's population is covered by health insurance; employees
of state-owned enterprises are entitled to receive virtually
free medical care. With the introduction of a new urban medical
insurance system in 2000, basic health care is offered to urban
workers. |
ECRON/ARI |
ECRON provides through
Astrom Research International (ARI) a full range of services
in China.
- Introduction of clients to key investigators at Chinese hospitals and clinics
- Trial management of phase I, II, III & IV clinical trials
- Monitoring of clinical trials according to GCP-ICH
- Application for regulatory SFDA and IRBs for trials in China
- GCP training of investigators and monitors
- Registration of medical device products in China |
Local
office/staff |
ECRON / ARI
133 Lin Ping Road, Building 10, Suite 504
Hong Kou district, 200086, Shanghai, China
Phone: +86 (13) 48 241 8678 |
|
CHINA
