China is one of the fastest growing global economies with a fifth population in the world, and is one of the largest healthcare markets around the world. Along with sustained economic and population growth, Chinese healthcare market has maintained annually average growth rate above 16 % since 1990s. By 2013, total value of drugs on Chinese healthcare market has reached RMB 1114 billion. On the Chinese healthcare market, imported drugs made by overseas and multinational pharmaceutical manufacturers account for about one fourth. It is estimated that total value of drugs on Chinese healthcare market will be likely to be more than RMB 1450 billion by 2015, and will surpass Japan to become the second largest drug market following the United States. The Chinese healthcare market will attract more and more overseas pharmaceutical manufacturers and producers to penetrate such market.
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Latest guidebook for Chinese Drug Recall Regulations (2014 Edition) is an essential resource for overseas and multinational pharmaceutical manufacturers and producers to handle a drug recall smoothly in China, which provides a detailed guidance of comprehensive and thorough knowledge of the Chinese drug recall regulations.
Table Of Content
Chapter 1
Introduction.2
Chapter 2 An Overview of Chinese Regulatory Authorities
for Drug Recall.4
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Chapter 3 General
Regulations for Drug Recall.6
3.1. Definitions.6
3.2. The special regulations for overseas manufacturers of imported
drugs.6
3.3. Who, Where and How to Submit the Report relating to Drug Recall?.6
3.4. The Manufacturers Duty for Drug Recall.7
3.5. The Distributor and User Facilitys Duty for Drug Recall.8
Chapter 4 Voluntary
Recall of Drugs.11
4.1. Regulations for Voluntary Recall of Drugs.11
4.2. An Entire Process of Voluntary Recall of Drugs.13
Chapter 5 Mandatory
Recall of Drugs.16
5.1. Regulations for Mandatory Recall of Drugs.16
5.2. Entire Process of Mandatory Recall of Drugs.18
Chapter 6 Legal
Liabilities.22
Chapter 7 Case
Study
Agent
(Xi'an-Janssen Pharmaceutical Ltd) Recall Imported Drug Caelyx and Velcade
produced at Ben Venue Laboratories, U.S.A. 25
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