China Pharmaceutical Regulation Strategies
China's pharmaceutical market is about $37 billion. To be successful in China, pharmaceutical companies need an excellent regulatory strategy.
The first issue is to establish a China pharmaceutical registration- either as a chemical drug, biological drug, or Traditional Chinese Medicine (TCM). Drugs can be imported into China only after they obtain product approval from the State Food and Drug Administration (SFDA)- the China drug administration.
The Chinese government pays for almost all of the drugs on the National Medical Insurance Drug List. There are also specific China drug regulations on advertising, labeling, and packaging. Clinical research and clinical studies are also exploding in China.
For more information on China drug approval issues, please see the following PBM publications and/or contact us to discuss your specific needs.
- China Pharmaceutical Regulatory Report 2011 (publication for sale)
- China Pharmaceutical Market Report 2011 (publication for sale)
- China Distribution for Medical Devices/Drugs/OTC Products (webcast for sale)
- Strategies for Success in China, Japan and India (webcast for sale)
- Changing Business Practices in the Chinese Pharmaceutical Market
- Business and Marketing Strategy for China's Pharmaceutical Market (webcast for sale)
- China Product Registration and Regulatory Issues Webcast (webcast for sale)


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