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China Pharmaceutical Regulatory Report 2011
Pacific Bridge Medical, Jan 2011, Pages: 74
This regulatory report includes an overview of the pharmaceutical and healthcare industry in China, as well as a discussion of all the relevant Chinese laws and regulations that govern the testing, registration, manufacture, import, marketing, and sale of pharmaceutical products. Specific topics for drug companies 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. These will help drug companies in their product registration process in China.
Updates for 2011 include:
- Latest healthcare developments in China and their impact on foreign drug companies
- China’s new healthcare reform policies and its impact on pharmaceutical regulations
- New Chinese pharmaceutical regulations and updated policies on drug manufacturing (GMP), distribution and clinical research in China
Also available
China Pharmaceutical Regulatory Report 2011 + Appendix
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