Pharmaceutical/Drug Registration in China

The pharmaceutical/drug market is currently worth about $37 billion. For pharmaceutical/drug companies in China, today is a very exciting time, but also a highly challenging one. Thanks to a rapidly rising China economy and newly prosperous citizens wanting better healthcare, the pharmaceutical market in China is growing quickly, at about 15% per year.

In China, drugs are classified as 3 types: Chemical Drugs, Biological Drugs, or Traditional Chinese Medicine/Natural Drugs. All drugs manufactured outside China must be registered via the imported drug application. The SFDA conducts a preliminary review of the dossier while the Center for Drug Evaluation (CDE) will do a technical review. Pharmaceutical Import Licenses or Drug Product Certificates are valid for 5 years.

PBM can act as your legal and after sales agent in China.

For more information on pharmaceutical/drug registration in China, please see the following PBM publications and/or contact us to discuss your specific needs.

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