China is one of the fastest growing global economies with a fifth population in the world, and is one of the largest healthcare markets around the world. Along with sustained economic and population growth, Chinese healthcare market has maintained annually average growth rate above 16 % since 1990s. By 2013, total value of drugs on Chinese healthcare market has reached RMB 1114 billion. On the Chinese healthcare market, imported drugs made by overseas and multinational pharmaceutical manufacturers account for about one fourth. It is estimated that total value of drugs on Chinese healthcare market will be likely to be more than 1450 billion RMB by 2015, and will surpass Japan to become the second largest drug market following the United States. The Chinese healthcare market will attract more and more overseas pharmaceutical manufacturers and producers to penetrate such market.
However, when searching on website of the Chinese regulatory authority of drugs, China Food and Drug Administration, you may find there are many announcements of adverse drug reaction reports for those that drugs made by overseas and multinational pharmaceutical manufacturers. How to report an adverse drug reaction and event to the Chinese regulatory authorities?
Chinese guidebook for Adverse Drug Reaction Reporting and Monitoring Regulations (2014) is an essential resource for overseas and multinational pharmaceutical manufacturers and producers to handle an adverse drug reaction reporting smoothly in China, which provides a detailed guidance of comprehensive and thorough knowledge of the Chinese adverse drug reaction reporting and monitoring regulations.
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