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China Pharmaceutical Regulatory Report 2009 (W/Appendix)
Pacific Bridge Medical, Jan 2009, Pages: 181
This report includes a brief overview of the pharmaceutical and healthcare industry in China, as well as a discussion of all the relevant laws and regulations that govern the testing, registration, manufacture, import, marketing, and sale of pharmaceutical products. Specific topics include: product registration, pricing and reimbursement, importation, GMP, GCP, orphan drugs, and intellectual property protection.
This report's appendix contains a full translation of the revised Administrative Provisions for Drug Registration, the recent overhaul of China's drug regulations. It also contains the annexes to this document detailing dossier submission requirements, all up-to-date.
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