Learn Regulatory Updates and Best Practices on Pharmacovigilance in the Greater China Region and Beyond

Back to the Future: Pharmacovigilance in China By Guo XioaJun

Both Pharmacovigilance (PV) and Pharmacoepidemiology (PE) are still young specialties in China.

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 researches.

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 (MOH).

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 Administration).

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:

• A lack of AE reporting awareness and attitudes among the frontline Health Care Professionals
• A lack of dedicated drug safety staffs and PV system in most local pharmaceutical companies
• Diverse regulatory requirements and interpretations against Council for International Organizations of Medical Sciences (CIOMS) or International Conference on Harmonisation (ICH) guidelines
• Inconvenience with using the online ADR reporting tool, caused by a focus on single case reporting rather than aggregate data as well as inaccurate codes and poor translations of Adverse Event (AE) terms.

Guo XiaoJun will be speaking at Pharmacovigilance China 2011.

For more details on the event email us at enquiry@iqpc.com.sg or visit www.pharmacovigilancechina.com

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