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 China Food and Drug Administration (CFDA) - 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.


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