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China Pharmaceutical Regulatory Report 2008 (with appendix)
Pacific Bridge Medical, April 2008, 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 overhauling of China’s drug regulations that just came into effect on October 1, 2007. It also contains the annexes to this document detailing dossier submission requirements, all up-to-date.
The report includes a 125-page appendix including translations of key pharmaceutical regulations, pharmaceutical statistics, registration forms, China CRO contacts, and a timeline for the pharmaceutical registration process.
Fully updated for 2008.
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