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市場調查報告書

中國副作用報告□監控規範指南

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

出版商 Access China Management Consulting 商品編碼 297656
出版日期 內容資訊 英文 50 Pages
商品交期: 最快1-2個工作天內
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中國副作用報告□監控規範指南 Chinese guidebook for Adverse Drug Reaction Reporting and Monitoring Regulations (2014)
出版日期: 2014年03月25日 內容資訊: 英文 50 Pages
簡介

中國2013年醫療市場規模達1兆4500億人民幣,超過日本成為全球第2大醫藥品□醫療設備市場。其中有1/4是海外進口,世界各國的製藥企業與醫療設備製造商皆受到中國市場吸引。另一方面、國內外出現許多醫藥□醫療設備副作用相關資訊,該如何處理已成為一大問題。

本報告針對中國醫藥□醫療設備副作用病例報告與監視網絡概要進行分析,提供、醫藥□醫療設備各種整體規範構造與監視制度、製造商□流通企業□醫療機關監控□報告體制與責任□手續、治療檢驗階段報告□監視體制、政府機關對應狀況、市民權利(資料公開狀況)調查、中國企業出口□進口跨國企業建議,目錄介紹如下。

第1部 醫藥副作用

第1章 介紹

第2章 醫藥副作用報告□監視相關一般規範

  • 定義
  • 醫藥副作用報告者
  • 外資製造商生產的進口藥品特殊規範
  • 外資製藥企業在中國領土內的製造規範
  • 進口藥販售業者規範
  • 中國在國外發生的重大藥物有害事件

第3章 中國醫藥副作用報告□監視網絡概要

  • 法規機關與機能
    • 市□縣等級的法規機關
    • 省□自治區等級的法規機關
    • 全國級法規機關
  • 中國醫藥副作用報告□監視網絡概要

第4章 副作用報告相關醫藥製造商義務

  • 責任與義務
  • 專門機關名稱與對應人員的必要條件
  • 副作用與病例報告
    • 個別病例報告
    • 群體的病例報告
    • 定期安全性情報更新
    • 製造商方面的副作用□獎勵報告全體流程
  • 中國在海外發生的重大副作用報告相關特殊規範
  • 醫藥副作用的管理與評價
  • 醫藥監視焦點

第5章 副作用報告相關醫藥販售業者義務

  • 責任與義務
  • 專門機關名稱與對應人員的必要條件
  • 副作用與病例報告
    • 個別病例報告
    • 群體的病例報告
  • 醫藥副作用的管理與評價

第6章 副作用報告相關醫療機關義務

  • 責任與義務
  • 專門機關名稱與對應人員的必要條件
  • 副作用與病例報告
    • 個別病例報告
    • 群體的病例報告
  • 醫藥副作用的管理與評價

第7章 副作用病例報告相關市民□法人□其他社會組織權利

第8章 情報公開與回應

第9章 法律責任

第10章 附錄

目錄

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.

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.

The organizations of this guidebook are arranged as follows. Chapter 2 provides the general regulations for adverse drug reaction reporting and monitoring, and the special regulations for overseas manufacturers of imported drugs. Chapter 3 provides an overview of Chinese monitoring network for adverse drug reaction 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 reporting and monitoring. Chapter 4 introduces the detailed 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, which is important for agents within the territory of China designated by overseas and multinational pharmaceutical manufacturers, because they must be in compliance with these regulations. Chapter 5 addresses the distributor's duty for adverse drug reaction reporting, also from the responsibilities and obligations, the operation procedures of adverse drug reaction and event reporting to the control and evaluation for adverse drug reaction, which is important for the distributors within the territory of China of overseas and multinational manufacturers of imported drugs, because they must be in compliance with these regulations. Chapter 6 elaborates the medical institution's duty for adverse drug reaction reporting. Chapter 7 provides a brief introduction of citizens, legal persons and other social organizations' right for adverse drug reaction reporting. Chapter 8 introduces the disclosure and feedback of information about adverse drug reactions and events. Chapter 9 addresses the legal liabilities for manufacturer, distributor and medical institution. Chapter 10 provides 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 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 Adverse Drug Reaction Reporting and Monitoring Regulations. After having skimmed through this guidebook, audiences can clearly acquire a comprehensive and thorough knowledge of the latest Chinese Adverse Drug Reaction Reporting and Monitoring Regulations. Access China Management Consulting Ltd hopes this guidebook, based on full and accurate regulations, can guide overseas and multinational pharmaceutical manufacturers and producers to achieve a successful entry into the Chinese drug market, and smoothly operate their companies in China.

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.

Table of Contents

Chapter 1 Introduction.

Chapter 2 General Regulations for Adverse Reaction Reporting and Monitoring.

  • 2.1. Definitions.
    • 2.1.1. Adverse Reaction of Drugs.
    • 2.1.2. Serious Adverse Reactions of Drugs.
    • 2.1.3. New Adverse Reactions of Drugs.
    • 2.1.4. Suspected Drugs.
    • 2.1.5. Simultaneously Using Drugs.
    • 2.1.6. Administration and Dosage.
    • 2.1.7. Medical and Health Institutions.
  • 2.2. Reporters of Adverse Drug Reaction .
  • 2.3. The special regulations for overseas manufacturers of imported drugs.
  • 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.
  • 2.6. The serious adverse drug events occurred outside of the territory of China.

Chapter 3 An Overview of Chinese Monitoring Network for Adverse Drug Reaction Reporting.

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

Chapter 4 Manufacturer's Duty for Adverse Drug Reaction Reporting.

  • 4.1. Responsibilities and obligations.
  • 4.2. Designation of Specialized Agency and Requirements of Outfitting Personnel.
  • 4.3. Adverse Reaction and Event Reporting.
    • 4.3.1. Individual Adverse Drug Reaction Report (An Adverse Drug Reaction (ADR) Case Report).
    • 4.3.2. Group Adverse Event Report .
    • 4.3.3. Periodic Safety Update Report.
    • 4.3.4. An Entire Process of Adverse Reaction and Event Reporting for Manufacturer .
    • Figure 4.3.4. An Entire Process of Adverse Reaction and Event Reporting for Manufacturer.
  • 4.4. The Special Regulations for Reporting Serious Adverse Event Occurred outside of the territory of China.
  • 4.5. Control and Evaluation for Adverse Drug Reaction.
  • 4.6. Focal Point Monitoring for Drugs.

Chapter 5 Distributor's Duty for Adverse Drug Reaction Reporting.

  • 5.1. Responsibilities and obligations.
  • 5.2. Designation of Specialized Agency and Requirements of Outfitting Personnel.
  • 5.3. Adverse Reaction and Event Reporting.
    • 5.3.1. Individual Adverse Drug Reaction Report (An Adverse Drug Reaction (ADR) Case Report).
    • 5.3.2. Group Adverse Event Report.3
  • 5.4. Control and Evaluation for Adverse Drug Reaction.

Chapter 6 Medical Institution's Duty for Adverse Drug Reaction Reporting.

  • 6.1. Responsibilities and obligations.
  • 6.2. Designation of Specialized Agency and Requirements of Outfitting Personnel.
  • 6.3. Adverse Reaction and Event Reporting.
    • 6.3.1. Individual Adverse Drug Reaction Report (An Adverse Drug Reaction (ADR) Case Report).
    • 6.3.2. Group Adverse Event Report .
  • 6.4. Control and Evaluation for Adverse Drug Reaction.

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

Chapter 8 Information Disclosure and Feedback.

Chapter 9 Legal Liabilities.

Chapter 10 Appendix.

  • 10.1. Form of Adverse Drug Reaction/ Event Reporting.
  • 10.2. Form of Basic Information of Group Adverse Drug Event Reporting.
  • 10.3. Form of Adverse Drug Reactions/ Event Occurred Outside of the Territory of China Reporting.

Chapter 1 Introduction.

Chapter 2 General Regulations for Medical Device Adverse Event Reporting and Monitoring.

  • 2.1. Definitions.
    • 2.1.1. Medical Device Adverse Event.
    • 2.1.2. Medical Device Adverse Event Monitoring.
    • 2.1.3. Serious Injuries.
    • 2.1.4. Medical and Health Institutions.
  • 2.2. The differentiation between the medical device adverse events and the quality accidents or medical malpractice.
  • 2.3. The adverse event reporting for products are on sale within the territory of China and outside of the territory of China.
  • 2.4. The adverse event reporting for medical device in clinical trials.
  • 2.5. The applicable regulations for medical device recall.
  • 2.6. The functions of medical device adverse event reporting content and statistical information.
  • 2.7. The reporters of medical device adverse events.
  • 2.8. The special regulations for overseas manufacturers of imported medical devices.

Chapter 3 Manufacturer's Duty for Medical Device Adverse Event Reporting.

  • 3.1. Responsibilities and obligations.
  • 3.2. Designation of Specialized Agency and Requirements of Outfitting Personnel.
  • 3.3. Main Monitoring Systems.
  • 3.4. Main Operation Procedures.
    • 3.4.1. Identification and Collection for Medical Device Adverse Events.
    • 3.4.2. Investigation and Evaluation of Medical Device Adverse Events.
  • 3.5. Medical Device Adverse Event Reporting.
    • 3.5.1. Individual Adverse Event Report (Suspected Medical Device Adverse Event Report).
    • 3.5.2. Unexpected and Group Adverse Event Report.
    • 3.5.3. Annual Summary Report.
    • 3.5.4. An Entire Process of Medical Device Adverse Event Reporting for Manufacturer.
    • Figure 3.5.4. An Entire Process of Medical Device Adverse Event Reporting for Manufacturer.
  • 3.6. Control of Adverse Events.
  • 3.7. Archives of Adverse Event Monitoring.

Chapter 4 Distributor's Duty for Medical Device Adverse Event Reporting.

  • 4.1. Responsibilities and obligations.
  • 4.2. Designation of Specialized Agency and Requirements of Outfitting Personnel.
  • 4.3. Main Monitoring Systems.
  • 4.4. Main Operation Procedures.
    • 4.4.1.Collection and Notification for Medical Device Adverse Events.
  • 4.5. Medical Device Adverse Event Reporting.
    • 4.5.1. Individual Adverse Event Report (Suspected Medical Device Adverse Event Report).
    • 4.5.2. Unexpected and Group Adverse Event Report.
    • 4.5.3. Annual Summary Report.
    • 4.5.4. An Entire Process of Medical Device Adverse Event Reporting for Distributor.
    • Figure 4.5.4. An Entire Process of Medical Device Adverse Event Reporting for Distributor.
  • 4.6. Control of Adverse Events.
  • 4.7. Archives of Adverse Event Monitoring.

Chapter 5 User Facility's Duty for Medical Device Adverse Event Reporting.

  • 5.1. Responsibilities and obligations.
  • 5.2. Designation of Specialized Agency and Requirements of Outfitting Personnel.
  • 5.3. Main Monitoring Systems .
  • 5.4. Main Operation Procedures.
    • 5.4.1. Identification and Collection for Medical Device Adverse Events.
    • 5.4.2. Analysis and Confirmation for Medical Device Adverse Events.
  • 5.5. Medical Device Adverse Event Reporting.
    • 5.5.1. Individual Adverse Event Report (Suspected Medical Device Adverse Event Report).
    • 5.5.2. Unexpected and Group Adverse Event Report.
    • 5.5.3. Annual Summary Report.
    • 5.5.4. An Entire Process of Medical Device Adverse Event Reporting for User Facility.
    • Figure 5.5.4. An Entire Process of Medical Device Adverse Event Reporting for User Facility.
  • 5.6. Control of Adverse Events.
  • 5.7. Archives of Adverse Event Monitoring.

Chapter 6 Citizens, Legal Persons and other Social Organizations' Right for Medical Device Adverse Event Reporting.

Chapter 7 An Overview of Chinese Monitoring Network for Medical Device Adverse Event Reporting.

  • 7.1. Regulatory Authorities and their Functions.
    • 7.1.1. Regulatory Authorities at the city and county level.
    • 7.1.2. Regulatory Authorities of Provinces, Autonomous regions and Municipalities directly under the Central Government.
    • 7.1.3. National Medical Device Adverse Event Monitoring technical institution (National Center for ADR Monitoring).
  • 7.2. An Overview of Chinese Monitoring Network for Medical Device Adverse Event Reporting.
    • Figure 7.2. An Overview of Chinese Monitoring Network for Medical Device Adverse Event Reporting.

Chapter 8 Regulations for Adverse Event Reporting of Medical Device in Clinical Trials.

Chapter 9 Appendix.

  • 9.1. Form of Suspected Medical Device Adverse Event Reporting.
  • 9.2. Supplementary Form of Medical Device Adverse Event Reporting.
  • 9.3. Annual Summary Form of Medical Device Adverse Event Reporting.
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