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Latest guidebook for Chinese Drug Recall Regulations (2014 Edition)

  • March 2014
  • -
  • Access China Management Consulting Ltd.
  • -
  • 26 pages

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.

However, when searching on website of the Chinese regulatory authority of drugs, China Food and Drug Administration, you may find there are many announcements of drug recall for those that drugs made by overseas and multinational pharmaceutical manufacturers. How to handle a drug recall smoothly in China? When is recall reporting voluntary vs. mandatory? What characteristics of the recall must you consider when making that determination? How to comply with Chinese drug recall regulations? The overseas and multinational pharmaceutical manufacturers and their senior executive officers engaging in regulatory affairs need a comprehensive and thorough knowledge of the Chinese regulations on drug recall. Otherwise the overseas and multinational pharmaceutical manufacturers and their imported drug into the Chinese mainland will lose a lucrative drug market. The regulations on drug recall between China and US-EU are different. Moreover, the cultural difference between China and Western countries as well as the language barriers will increase the challenge faced by overseas and multinational pharmaceutical manufacturers and producers.

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.

Latest guidebook for Chinese Drug Recall Regulations (2014 Edition) provide highlights as followings:

- An overview of organizational structure of Chinese regulatory authorities for drug recall and the complete picture of organizational structure of Chinese regulatory authorities for drug recall.
- The Chinese general regulations for drug recall, which cover the definitions relating to drug recall, the answers of who, where and how to submit the report relating to drug recall, the pharmaceutical manufacturer’s duty for drug recall, the distributor and user facility’s duty for drug recall, the investigation and evaluation of drug safety hazards, the classification for drug recall, as well as the special regulations for overseas manufacturers of imported drugs.
- The detailed regulations for voluntary recall of drugs, from the time limits of notifying, the indispensable content of the recall plan and the investigation and evaluation report, the report of recall program implementation situation to smoothly navigate complex regulatory requirements step by step for agents within the territory of China designated by overseas manufacturers of imported drugs, because they must be in compliance with these regulations.
- An entire process of voluntary recall of drug.
- The detailed regulations for mandatory recall of drug, which covers how would trigger a mandatory recall of drug, how the pharmaceutical manufacturer copes with a mandatory recall of drug, and how to handle a mandatory recall of drug smoothly in China for agents within the territory of China designated by overseas manufacturers of imported drugs, because they must be in compliance with these regulations.
- An entire process of mandatory recall of drug.
- The detailed legal liabilities for the pharmaceutical manufacturer, the distributors, and the user facilities of drugs for drug recall.
- A case study of drug recall to expose practical operation.

The audiences of this guidebook are overseas pharmaceutical companies wishing to enter into the Chinese drug market, and multinational pharmaceutical companies have penetrated into the Chinese drug market, and their senior executive officers engaging in regulatory affairs expecting to understand the latest Chinese Drug Recall Regulations. After having skimmed through this guidebook, audiences can clearly acquire a comprehensive and thorough knowledge of the latest Chinese Drug Recall Regulations.

Table Of Contents

Latest guidebook for Chinese Drug Recall Regulations (2014 Edition)
Table of Contents.1

Chapter 1 Introduction.2

Chapter 2 An Overview of Chinese Regulatory Authorities for Drug Recall.4
Figure 2.1. Organizational Structure of Chinese Regulatory Authorities for Drug Recall.5

Chapter 3 General Regulations for Drug Recall.6
3.1. Definitions.6
3.1.1. Drug Recall.6
3.1.2. Safety Hazards.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 Manufacturer's Duty for Drug Recall.7
3.5. The Distributor and User Facility's Duty for Drug Recall.8
3.6. Investigation and Evaluation of Drug Safety Hazards.9
3. 7. Classification for Drug Recall.10

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
Figure 4.2. An Entire Process of Voluntary Recall of Drugs.14
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
Figure 5.2. An Entire Process of Mandatory Recall of Drugs.19

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

List of Figures

Figure 2.1. Organizational Structure of Chinese Regulatory Authorities for Drug Recall.
Figure 4.2. An Entire Process of Voluntary Recall of Drugs.
Figure 5.2. An Entire Process of Mandatory Recall of Drugs.

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