05 - 06 July, 2011, Renaissance Beijing Capital Hotel, Beijing, China
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Back to the Future: Pharmacovigilance in China By Guo XioaJun
Both Pharmacovigilance (PV) and Pharmacoepidemiology (PE) are still young specialties
PE was introduced into China in late 80’s or early 90’s. In 1992, the professional journal,
Chinese Journal of Pharmacoepidemilogy, was publicly issued.
In 1995, the Special Committee of Pharmacoepidemiology was set up under the Chinese
Pharmaceutical Association, and the 1st National Conference on Epidemiology was held.
In September 2005, National Adverse Drug Reaction (ADR) Center held the International
Forum on ADR Monitoring in Beijing, in collaboration with AstraZeneca.
In September 2006, AstraZeneca-sponsored the Shanghai Center for Adverse Drug
Reaction (ADR) Monitoring to successfully hold the First Asian International Society for
pharmacoepidemiology Conference and the Third Shanghai International Conference on
Rational Drug Use and Pharmacoepidemiology in Shanghai. The major challenge in the
PE area is that very few databases or registries are available for pharmacoepidemiology
PV was first translated into Chinese in 1992. Between 1989 and 1990, Adverse Drug
Reaction Reporting was pioneered by several Chinese medical institutions, under
instruction of the Department of Medical Administration in the Ministry of Health
In 1998, a National ADR Monitoring Center was established in Ministry of Health
(MOH). In 1999, Administrative Regulation on Adverse Drug Reaction Monitoring (trial
version) was issued by State Drug Administration (later renamed as State Food and Drug
However, it was not until 2004 that the Administrative Regulation on Adverse Drug
Reaction Reporting and monitoring (1st version) was issued. As a result, the number of
ADR cases reported increased rapidly, from about 170,000 cases in 2005 to 690,000
cases in 2010. Also in 2004, the Chinese Journal of Pharmacovigilance was issued. It
shows the basic PV system has been established in China.
Most multinational pharmaceutical companies have established specialised drug
safety/patient safety departments to ensure they meet both national and international
regulatory requirements. In addition, there is a PV working group in R&D-Based
Pharmaceutical Association Committee (RDPAC), which consists of safety leaders
from big multinational companies who exchange best practice and communicate with
China Regulatory Authority.
Despite the above improvements, there are still a lot of challenges. These include:
Guo XiaoJun will be speaking at Pharmacovigilance China 2011.
For more details on the event email us at email@example.com or visit www.pharmacovigilancechina.com
The very first event tailored on PV on a great Asian perspective!
Simple enough to a beginner, complex enough for the experienced. Brilliant!
Very interesting with experienced key players
Very well organised conference. Attendees mix was nice – including industry and regulators! Well done!
A great opportunity to network with peers in the region!
This conference offers the opportunity for those working in pharmacovigilance to share expertise and learn about best practice and challenge the way they do things.
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