Overview of EU and U.S. PV Regulations and PV Regulation Trend after China Joined ICH--China

China

In China, people often equate PV with adverse drug reaction (ADR) monitoring, but in fact, PV is not simply ADR monitoring; it is a gradual outward expanding process with ADR monitoring at its core. China’s PV work started late, with the entire system roughly experiencing the following periods:

1989-1999 was the preparation period in which pilot work was conducted. The Ministry of Health (dissolved) set up the Center for ADR Monitoring at China National Institute for the Control of Biological Products in 1989. Thereafter, provinces, autonomous regions and municipalities of China successively set up the center for ADR monitoring. The Good Manufacturing Practice for Drugs in 1998 proposed that pharmaceutical enterprises should establish the complaint and ADR reporting system.

1999-2004 was the initial development period. In 1999, the State Drug Administration (dissolved) and Ministry of Health (dissolved) organized the formulation of and issued the Administrative Measures for the Monitoring of Adverse Drug Reactions (Interim) to make detailed provisions on detailed content of ADR monitoring, marking the start of implementation of the ADR reporting system in China; in the same year, the National Center for ADR Monitoring, China (formerly the Center for ADR Monitoring of the Ministry of Health (dissolved)) was established; the Drug Administration Law amended in 2001 explicitly specified that China should implement ADR reporting system; the Interim Provisions on the Administration of Pharmaceutical Affairs of Medical Institutions was issued in 2002, and the Good Clinical Practice started to be implemented in 2003, to promote the establishment of ADR early warning mechanism.

2004-2011 was the rapid development period. In March 2004, the Ministry of Health (dissolved) and State Food and Drug Administration (SFDA, dissolved) jointly issued the Administrative Measures for the Reporting and Monitoring of Adverse Drug Reactions, to increase ADR regulation efforts, and require pharmaceutical factories, pharmaceutical product circulators and health organizations to monitor and report all adverse reactions. Provinces, autonomous regions and municipalities of China have all set up the center for ADR monitoring by the end of 2004, marking the initial formation of the organizational system framework of ADR monitoring in China.

The period after 2011 is the steady development period. China’s PV system has entered the steady development period with the implementation of the newly amended Measures for the Reporting and Monitoring of Adverse Drug Reactions in 2011.

China’s PV system is now generally divided into four levels of pharmaceutical product safety administrative regulation system, including state, province, city, and county, with ADR monitoring institutions at each level forming the technical support system for conducting ADR monitoring and evaluation. Along with the continuous exploration and development for over 20 years, the method of ADR reporting of monitoring institutions at each level has changed from paper reporting, stand-alone software reporting, to intelligent online direct reporting, and the ADR discovery, reporting, handling, risk control, and emergency management levels have been improved constantly, however, from the overall perspective, China still has certain gaps with the developed countries in Europe and America in terms of division of liability subjects, life cycle of pharmaceutical product monitoring, data collection, mining and management, disclosure of warning information, and application of risk management, etc.

However, the globalization of market will bring globalization of drug regulation, wherein, the trend of PV work becoming normalized and scientific is irresistible. And Chinese pharmaceutical practitioners’ active learning and participation in the PV work will serve as the foundation for enterprise compliance and smooth operation.

Related:

Overview of EU and U.S. PV Regulations and PV Regulation Trend after China Joined ICH--U.S.

Overview of EU and U.S. PV Regulations and PV Regulation Trend after China Joined ICH--EU

References:

1. Establishment and Operation of EU Pharmacovigilance System and Its Implementation Progress;

2. Official website of FDA

3. Official website of EMA

4. Official website of CFDA

5. Official website of NMPA

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