China Pharmaceutical Guidebook: 2013 - Vol. III
Product Details
China need not remain a mystery.
- Do you know the ins and outs of Chinese drug import laws and regulations?
- Could you complete a Chinese drug import application … error-free?
- Would you be able to set up a clinical trial acceptable to Chinese authorities?
If your company wants to enter the Chinese market, this is the resource you need — a step-by-step guide through the maze of Chinese drug import policies and procedures, written in the language you speak: English, plain and simple. You’ll discover:
- Structure of China’s FDA and affiliates, along with contact information
- Forms, documents and other materials to accompany drug import registration applications
- Procedures to submit supplementary applications
- 20 key terms relating to importing drugs into China
- Timelines to apply for registration and re-registration
- Procedures for applying to repackage imported drugs
- Procedures for applying to conduct clinical trials
- Classification of drugs
- And much more!
The China Pharmaceutical Guidebook: 2013 is really four books in one:
Vol. I, Latest Chinese Regulations for Imported Drug Registration, spells out how to register imported drugs with China’s Food and Drug Administration (CFDA). An inside look at Chinese rules and procedures, Vol. I features:
- Overview of the responsibilities and organization of the CFDA
- Interpretation of imported drug registration rules — classification, definitions, initial application for registration, supplementary applications and re-registration, clinical trials and time limits for registration
- Step-by-step map of the application process
- Expert advice on navigating the system
- Key laws and regulations and application forms — in English.
You’ll want to order Volume I for certain, then supplement it as appropriate with any or all of three companion volumes:
- Vol. II: Registration Application for Imported Chemical Drugs
- Vol. III: Registration Application for Imported Biological Products
- Vol. IV: Registration Application for Imported Traditional Chinese Medicines and Natural Medicines
Each volume is $750 per copy, delivered electronically as a PDF file.
China’s regulatory system is complex and lacks the transparency you expect as a U.S. drugmaker. Language and cultural differences further muddy the waters. Why risk missteps? Get ready now for the China boom-to-end-all-booms. Order your copies of China Pharmaceutical Guidebook: 2013.
Buy Now
China Pharmaceutical Guidebook: 2013 is created and published by Access China Management Consulting Ltd., a specialist in providing guidance to foreign manufacturers seeking entry to the China market; and distributed by FDAnews. China Pharmaceutical Guidebook: 2013 is available online in PDF format only. Each volume is $750 per single copy, delivered instantaneously via email.
Your purchase is nonrefundable. All sales are final.