市場調査レポート

中国における副作用の報告・監視規制のガイドライン

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

発行 Access China Management Consulting 商品コード 297656
出版日 ページ情報 英文 50 Pages
納期: 即日から翌営業日
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中国における副作用の報告・監視規制のガイドライン Chinese guidebook for Adverse Drug Reaction Reporting and Monitoring Regulations (2014)
出版日: 2014年03月25日 ページ情報: 英文 50 Pages
概要

中国の2013年の医療市場の規模は1超4500億人民元に達し、日本を追い抜いて世界第2位の医薬品・医療機器市場となっています。そのうちの1/4が海外からの輸入品で、世界各国の製薬企業や医療機器メーカーが中国市場に引き寄せられています。しかし一方で、国の内外から医薬品・医療機器の副作用に関する情報が多数寄せられるようにもなっており、それに如何にして対処するのかが問題となっています。

当レポートでは、中国における医薬品・医療機器の副作用の症例報告および監視ネットワークの概要について分析し、医薬品・医療機器の各々について、全体的な規制構造や監視制度、メーカー側・流通企業側・医療機関側の監視・報告体制と責任・手続、治験段階の報告・監視体制、政府機関側の対応状況、市民の側の権利(情報公開状況ほか)などを調査すると共に、中国企業に輸出・進出する多国籍企業に向けての提言を盛り込んで、概略以下の構成でお届けします。

第1部 医薬品の副作用

第1章 イントロダクション

第2章 医薬品の副作用の報告・監視に関する一般的規制

  • 定義
  • 医薬品副作用の報告者
  • 外資系メーカー製の輸入薬に対する特殊規制
  • 外資系製薬企業が中国領内で製造する場合の規制
  • 輸入薬の販売業者に対する規制
  • 中国国外で発生した重大な薬物有害事象

第3章 中国の医薬品副作用報告・監視ネットワークの概要

  • 規制当局とその機能
    • 市・県レベルの規制当局
    • 省・自治区レベルの規制当局
    • 全国レベルの規制当局
  • 中国の医薬品副作用報告・監視ネットワークの概要

第4章 副作用の報告に関する医薬品メーカーの義務

  • 責任と義務
  • 専門機関の名称と対応人員の必要条件
  • 副作用と症例報告
    • 個別の症例報告
    • グループ単位での症例報告
    • 定期的な安全性情報の更新
    • メーカー側の副作用・奨励報告の全体的プロセス
  • 中国国外で発生した重大な副作用の報告に関する特殊規制
  • 医薬品副作用の管理と評価
  • 医薬品監視の焦点

第5章 副作用の報告に関する医薬品販売業者の義務

  • 責任と義務
  • 専門機関の名称と対応人員の必要条件
  • 副作用と症例報告
    • 個別の症例報告
    • グループ単位での症例報告
  • 医薬品副作用の管理と評価

第6章 副作用の報告に関する医療機関の義務

  • 責任と義務
  • 専門機関の名称と対応人員の必要条件
  • 副作用と症例報告
    • 個別の症例報告
    • グループ単位での症例報告
  • 医薬品副作用の管理と評価

第7章 副作用の症例報告に関する市民・法人・他の社会組織の権利

第8章 情報公開とフィードバック

第9章 法的責任

第10章 付録

第2章 医療機器の副作用

第1章 イントロダクション

第2章 医療機器の副作用の報告・監視に関する一般的規制

  • 定義
  • 医療機器の副作用と、品質問題・医療過誤との違い
  • 中国国内/国外の医療機器の副作用の報告制度
  • 治験段階における医療機器の副作用
  • 医療機器のリコールに適用される規制
  • 医療機器の副作用に関する報告機能と統計情報
  • 医療機器の副作用の報告者
  • 外資系メーカー製の輸入医療機器に対する特殊規制

第3章 副作用の報告に関する医療機器メーカーの義務

  • 責任と義務
  • 専門機関の名称と対応人員の必要条件
  • 主な監視制度
  • 主な運用課程
    • 副作用の症例の特定・収集
    • 副作用の症例の調査・評価
  • 医療機器の副作用の症例報告
    • 個別の症例報告
    • 抜き打ち・グループ単位での症例報告
    • 年間報告
    • メーカー側の副作用・奨励報告の全体的プロセス
  • 副作用の制御
  • 副作用症例監視の記録

第4章 副作用の報告に関する医療機器販売業者の義務

  • 責任と義務
  • 専門機関の名称と対応人員の必要条件
  • 主な監視制度
  • 主な運用課程
  • 医療機器の副作用の症例報告
    • 個別の症例報告
    • 抜き打ち・グループ単位での症例報告
    • 年間報告
    • メーカー側の副作用・奨励報告の全体的プロセス
  • 副作用の制御
  • 副作用症例監視の記録

第6章 副作用の報告に関する利用施設の義務

  • 責任と義務
  • 専門機関の名称と対応人員の必要条件
  • 主な監視制度
  • 主な運用課程
    • 副作用の症例の特定・収集
    • 副作用の症例の分析・確定
  • 医療機器の副作用の症例報告
    • 個別の症例報告
    • 抜き打ち・グループ単位での症例報告
    • 年間報告
    • メーカー側の副作用・奨励報告の全体的プロセス
  • 副作用の制御
  • 副作用症例監視の記録

第6章 医療機器の副作用の症例報告に関する市民・法人・他の社会組織の権利

第7章 中国における治験段階での医療機器の副作用の症例報告に対する監視ネットワークの概要

  • 規制当局とその機能
    • 市・県レベルの規制当局
    • 省・自治区レベルの規制当局
    • 全国レベルの規制当局
  • 中国の医療機器の副作用の症例報告のための監視ネットワークの概要

第8章 治験段階での医療機器の副作用報告に関する規制

第9章 付録

目次

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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