China Pharmaceutical Guidebook: 2013 - Vol. II

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1 - 9999
1 - 9999
April 2013

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?

Order Today

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.

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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.