This spiral-bound, 5" x 7.5" book is a compilation of various English translations of regulatory and guidance documents from the State Food & Drug Administration and Ministry of Health of the People's Republic of China. It includes the laws governing the registration and approval of drugs; and regulations on Good Clinical Practice and Good Manufacturing Practice, among others.
Who Uses this Book?
• English-speaking US or P.R. China staff conducting research in China
• China-based staff responsible for complying with China's Good
Manufacturing Practice regulations
• GCP and GMP Training personnel
• Regulatory and Legal departments
What's the Price?
• 1-249 copies: $15.95 • 250-499 copies: $14.95
• 500-749 copies: $13.95 • 750+ copies: $12.95
Custom Cover Prices*?
• 1-24 copies: unavailable • 25-100 copies: $2.00/book
• 100-249 copies: $1.00/book • 250+ copies: No charge
* Based on quantities of a single book title
• Drug Administration Law of the People's Republic of China
• Regulations for Implementation of the Drug Administration
Law of the People's Republic of China
• Provisions for Drug Registration in the People's Republic of
• Regulations on Administrative Protection for
Pharmaceuticals in the People's Republic of China
• Special Review and Approval Procedure for Drug
Registration of the State Food and Drug Administration,
People's Republic of China
• Regulation on Good Clinical Practice in the People's Republic of China
• Regulation on Good Manufacturing Practice in the People's
Republic of China
Click here to see an enlarged pdf cover