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Chinese Adverse Drug Reaction Reporting & Monitoring Regulations 2014

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 1450 billion RMB 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 adverse drug reaction reports for those that drugs made by overseas and multinational pharmaceutical manufacturers. How to report an adverse drug reaction and event to the Chinese regulatory authorities? Who should report adverse drug reaction and event to the Chinese regulatory authorities? How the Chinese regulatory authorities to monitor the adverse drug reaction and event reporting? How to comply with Chinese regulations for adverse drug reaction reporting and monitoring? A series of questions are facing overseas and multinational pharmaceutical manufacturers. 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 for adverse drug reaction reporting and monitoring. The regulations on adverse drug reaction reporting and monitoring 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.

Place a direct purchase order of "Chinese guidebook for Adverse Drug Reaction Reporting and Monitoring Regulations (2014)" report @ http://bit.ly/Qabm47.

Chinese guidebook for Adverse Drug Reaction Reporting and Monitoring Regulations (2014) is an essential resource for overseas and multinational pharmaceutical manufacturers and producers to handle an adverse drug reaction reporting smoothly in China, which provides a detailed guidance of comprehensive and thorough knowledge of the Chinese adverse drug reaction reporting and monitoring regulations.

Report Highlights

  • Chinese general regulations for adverse drug reaction and event reporting and monitoring, and the special regulations for adverse drug reaction and event reporting and monitoring of overseas manufacturers of imported drugs into the Chinese drug market.
  • The detailed Chinese regulations for the manufacturer’s duty for adverse drug reaction and event reporting, from the responsibilities and obligations, the operation procedures of adverse drug reaction and event reporting, the control and evaluation for adverse drug reaction, the focal point monitoring for drugs, the special regulations for reporting serious adverse event occurred outside of the territory of China to an entire process of adverse drug reaction and event reporting for manufacturer to guide agents within the territory of China designated by overseas and multinational pharmaceutical manufacturers to smoothly handle complex regulatory requirements step by step, because they must be in compliance with these regulations.
  • The detailed Chinese regulations for the distributor’s duty for adverse drug reaction and event reporting, from the responsibilities and obligations, the operation procedures of adverse drug reaction and event reporting to the control and evaluation for adverse drug reaction to guide distributors within the territory of China of overseas and multinational manufacturers of imported drugs to smoothly navigate complex regulatory requirements step by step, because they must be in compliance with these regulations.
  • The detailed Chinese regulations for medical institution’s duty for adverse drug reaction reporting.
  • An overview of Chinese monitoring network for adverse drug reaction and event reporting, which covers the detailed regulatory authorities at various administrative levels and their functions, and the complete picture of Chinese monitoring network for adverse drug reaction and event reporting and monitoring to provide a direction of gateway for adverse drug reaction and event reporting.
  • A brief introduction of citizens, legal persons and other social organizations’ right for adverse drug reaction reporting.
  • The Chinese regulations for disclosure and feedback of information about adverse drug reactions and events.
  • The Chinese regulations for legal liabilities of manufacturer, distributor and medical Institution to report and monitor the adverse drug reactions and events.
  • A full set of the English and Chinese bilingual forms relating to adverse drug reaction and event reporting to facilitate audiences to clearly understand submitted forms for adverse drug reaction and event reporting.
  • The detailed Chinese regulations for the user facility’s duty for medical device adverse event reporting.
  • An overview of Chinese monitoring network for medical device adverse event reporting, which covers the detailed regulatory authorities at various administrative levels and their functions, and the complete picture of Chinese monitoring network for medical device adverse event reporting and monitoring to provide a direction of gateway for medical device adverse event reporting.
  • The Chinese regulations for adverse event reporting of medical device in clinical trials.
  • A full set of the English and Chinese bilingual forms relating to medical device adverse event reporting to
    facilitate audiences to clearly understand submitted forms for medical device adverse event reporting.

Complete report available @ http://bit.ly/1drg1Jj.

Table of Contents

Chapter 1 Introduction.4

Chapter 2 General Regulations for Adverse Reaction Reporting and Monitoring.6
2.1. Definitions.6
2.1.1. Adverse Reaction of Drugs.6
2.1.2. Serious Adverse Reactions of Drugs.6
2.1.3. New Adverse Reactions of Drugs.6
2.1.4. Suspected Drugs.7
2.1.5. Simultaneously Using Drugs.7
2.1.6. Administration and Dosage.7
2.1.7. Medical and Health Institutions.7
2.2. Reporters of Adverse Drug Reaction .8
2.3. The special regulations for overseas manufacturers of imported drugs.8
2.4. The regulations for pharmaceutical manufacturers within the territory of China of multinational pharmaceutical companies 
2.5. The regulations for distributors of imported drugs.8
2.6. The serious adverse drug events occurred outside of the territory of China.8

Chapter 3 An Overview of Chinese Monitoring Network for Adverse Drug Reaction Reporting.9
3.1.Regulatory Authorities and their Functions.10
3.1.1. Regulatory Authorities at the city and county level.10
3.1.2. Regulatory Authorities of Provinces, Autonomous regions and Municipalities directly under the Central Government.11
3.1.3 National Regulatory Authorities.12
3.2. An Overview of Chinese Monitoring Network for Adverse Drug Reaction Reporting.14
Figure 3.2. An Overview of Chinese Monitoring Network for Adverse Drug Reaction Reporting.15

Chapter 4 Manufacturer’s Duty for Adverse Drug Reaction Reporting.16
4.1. Responsibilities and obligations.16
4.2. Designation of Specialized Agency and Requirements of Outfitting Personnel.17
4.3. Adverse Reaction and Event Reporting.17
4.3.1. Individual Adverse Drug Reaction Report (An Adverse Drug Reaction (ADR) Case Report).18
4.3.2. Group Adverse Event Report .20
4.3.3. Periodic Safety Update Report.21
4.3.4. An Entire Process of Adverse Reaction and Event Reporting for Manufacturer .23
Figure 4.3.4. An Entire Process of Adverse Reaction and Event Reporting for Manufacturer.24
4.4. The Special Regulations for Reporting Serious Adverse Event Occurred outside of the territory of China.27
4.5. Control and Evaluation for Adverse Drug Reaction.27
4.6. Focal Point Monitoring for Drugs.29

Chapter 5 Distributor’s Duty for Adverse Drug Reaction Reporting.29
5.1. Responsibilities and obligations.29
5.2. Designation of Specialized Agency and Requirements of Outfitting Personnel.30
5.3. Adverse Reaction and Event Reporting.30
5.3.1. Individual Adverse Drug Reaction Report (An Adverse Drug Reaction (ADR) Case Report).31
5.3.2. Group Adverse Event Report.31 
5.4. Control and Evaluation for Adverse Drug Reaction.32

Chapter 6 Medical Institution’s Duty for Adverse Drug Reaction Reporting.33
6.1. Responsibilities and obligations.33
6.2. Designation of Specialized Agency and Requirements of Outfitting Personnel.34
6.3. Adverse Reaction and Event Reporting.34
6.3.1. Individual Adverse Drug Reaction Report (An Adverse Drug Reaction (ADR) Case Report).34
6.3.2. Group Adverse Event Report .35
6.4. Control and Evaluation for Adverse Drug Reaction.36

Chapter 7 Citizens, Legal Persons and other Social Organizations’ Right for Adverse Drug Reaction Reporting.37

Chapter 8 Information Disclosure and Feedback.37

Chapter 9 Legal Liabilities.38

Chapter 10 Appendix.40
10.1. Form of Adverse Drug Reaction/ Event Reporting.41
10.2. Form of Basic Information of Group Adverse Drug Event Reporting.45
10.3. Form of Adverse Drug Reactions/ Event Occurred Outside of the Territory of China Reporting.49