Welcome Guest | Register / Login

Chinese guidebook for Adverse Drug Reaction Reporting and Monitoring Regulations (2014)

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

Why http://www.marketreportsonline.com/
Price
Live Chat
Live Chat by Comm100