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中国における医薬品臨床試験実施のための最新ガイドブック:規制から実施まで

Latest Guidebook for Conducting Pharma Clinical Trials in China: From Regulations to Practice (2014 Edition)

発行 Access China Management Consulting 商品コード 308353
出版日 ページ情報 英文 191 Pages
納期: 即日から翌営業日
価格
本日の銀行送金レート: 1USD=114.77円で換算しております。
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中国における医薬品臨床試験実施のための最新ガイドブック:規制から実施まで Latest Guidebook for Conducting Pharma Clinical Trials in China: From Regulations to Practice (2014 Edition)
出版日: 2014年08月25日 ページ情報: 英文 191 Pages
概要

中国は世界最大の医療市場のひとつです。持続的な経済・人口の成長および人口の高齢化によって、中国の医療市場は1990年代以降、16%以上の年間平均成長率を維持しています。2013年までに中国の医療市場における医薬品総額は1兆1,140億人民元(RMB)に達しています。中国の医療市場では海外・多国籍医薬品メーカーが製造する輸入薬が4分の1を占めています。中国の医療市場における医薬品総額は2015年までに1兆4,500億RMB以上になると見られ、日本を抜いて米国に次ぐ世界第2位の医薬品市場となる見込みです。多くの海外・多国籍医薬品メーカーはこの医薬品市場で大きなチャンスを得るため、医薬品の治験を中国で実施しています。しかし、中国のGCP(医薬品臨床試験実施基準)コンプライアンスへのアプローチは独特であり、海外・多国籍医薬品メーカーは治験に関する最新の中国の規制に ついての知識が必要です。

当レポートでは、中国における輸入薬登録のための治験に関する最新の規制について情報を提供しており、中国のGCP(医薬品臨床試験実施基準)ガイダンスなどをまとめ、お届けいたします。

第1章 エグゼクティブサマリー

第2章 中国の医薬品治験関係法令

第3章 中国の医薬品治験当局の概要

  • CFDA(中国国家食品薬品監督管理局)の主な責任
  • CFDAの組織構造
  • 輸入医薬品登録の治験申請・認可のロードマップ

第4章 輸入医薬品の治験を実施する前に備える情報

  • 定義
  • 医薬品の分類

第5章 輸入医薬品登録の治験申請・認可に関する一般的法律

  • 輸入医薬品登録の治験申請・認可に関する一般的法律
  • 輸入医薬品治験特定の規制

第6章 輸入医薬品登録の治験における全関係者の責任

  • スポンサーの責任
  • モニターの責任
  • 倫理委員会の責任
  • 治験責任医師の責任

第7章 輸入医薬品登録の治験における申請・認可手順

第8章 輸入医薬品登録の申請フォーム

  • 輸入医薬品登録の申請フォーム
  • 輸入医薬品登録の申請フォーム記入のための注記

第9章 輸入化学薬品登録用治験の実用的ガイダンス

  • 輸入化学薬品登録用治験の一般的規制
  • 輸入化学薬品登録用治験の特定規制
  • 輸入化学薬品登録用治験のデータ・資料

第10章 輸入生物学的製剤登録用治験の実用的ガイダンス

  • 治療生物学的製剤
  • 予防生物学的製剤

第11章 輸入生薬・漢方薬登録用治験の実用的ガイダンス

  • 輸入生薬・漢方薬登録用治験の一般的規制
  • 輸入生薬・漢方薬登録用治験の特定規制
  • 輸入生薬・漢方薬登録用治験のデータ・資料
  • 輸入生薬・漢方薬登録用治験のデータ・資料要件
  • 輸入生薬・漢方薬登録用治験のデータ・資料の注記
  • 輸入生薬・漢方薬登録用治験のデータ資料の提出

第12章 付録

目次
Product Code: ACMC 201408003

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 as well as an ageing population, 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. Many overseas and multinational pharmaceutical manufacturers are ardently conducting clinical trials for their drugs in China to seize a larger part of such drug market. However, the Chinese approach to GCP compliance is unique, from the application and approval process, the requirements for ethics committees, sponsors and investigators to the application dossiers. To enter such a lucrative drug market, overseas and multinational pharmaceutical manufacturers and producers must have a comprehensive and thorough knowledge of the latest Chinese regulations on clinical trials. Otherwise, the restrictive legal requirements and approval delays eat up your development time and budget.

This Latest Guidebook for Conducting Pharma Clinical Trials in China: From Regulations to Practice (2014 Edition) not only provided a comprehensive and thorough knowledge of the latest Chinese regulations on clinical trials for imported drug registration but also introdued the practical operation how to comply with the Chinese GCP to guide you use the Chinese trial venues to keep drug development lean and agile in the "post-patent-cliff" world step by step.

The organizations of this guidebook are arranged as follows. Chapter 2 provides an overview of the Chinese applicable laws and regulations for drug clinical trials. Chapter 3 introduced an overview of Chinese regulatory authorities for drug clinical trials to give the direction of gateway for clinical trials of imported drugs. Chapter 4 elaborated the definitions of some basic terms used in application and approval process of clinical trials for drug registration and the Chinese unique classification of drug registration, from the chemical drugs, biological products, natural medicines to traditional Chinese medicines (TCMs). Chapter 5 introduced the general regulations on application and approval for clinical trials of imported drug registration. Chapter 6 introduced the every party's responsibilities in clinical trials for imported drug registration. Chapter 7 delineated an entrie process of application and approval procedures for clinical trials of imported drug registration. Chapter 8 provided the full text in English of "Drug Registration Application Form for Imported Drug" to guide you fill it step by step. Chapter 9 gave the practical guidance for clinical trials of imported chemical drug registration, from the general and special regulations on clinical trials for imported chemical drug registration, the requirements for data and materials of application for approval of clinical trials for imported chemical drugs to the data and materials submission of application for approval of clinical trials for imported chemical drugs. Chapter 10 provided the practical guidance for clinical trials of imported biological product registration, also from the general and special regulations on clinical trials for imported biological product registration, the requirements for data and materials of application for approval of clinical trials for imported biological products to the data and materials submission of application for approval of clinical trials for imported biological products. Chapter 11 introduced the practical guidance for clinical trials of imported natural medicine and traditional Chinese medicine registration, again from the general and special regulations on clinical trials for imported natural medicine and traditional Chinese medicine registration, the the requirements for data and materials of application for approval of clinical trials for imported natural medicines and traditional Chinese medicines to the data and materials submission of application for approval of clinical trials for imported natural medicines and traditional Chinese medicines. Chapter 12 Appendices provided the full text in English of "Drug Administration Law of the People's Republic of China", "Regulations for Implementation of the Drug Administration Law of the People's Republic of China" and "The Chinese Good Clinical Practice of Pharmaceutical Products".

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 how to conduct smoothly clinical trials for their pharmaceutical products in China, and how to comply with the Chinese GCP. After having skimmed through this guidebook, audiences can clearly acquire not only a comprehensive and thorough knowledge of Chinese regulations on clinical trials for imported drug registration but also the practical operation how to comply with the Chinese GCP. 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 clinical trial market, and smoothly operate clinical trial for their products in China.

Report Highlights

  • An overview of the Chinese applicable laws and regulations for drug clinical trials.
  • An overview of organizational structure of Chinese regulatory authorities for drug clinical trials to give the direction of gateway for clinical trials of imported drugs.
  • The Chinese definitions of some basic terms used in application and approval process of drug clinical trials for drug registration, and the Chinese unique classification of drug registration, from the chemical drugs, biological products, natural medicines to traditional Chinese medicines (TCMs).
  • Chinese unique every party's responsibilities in clinical trials for imported drug registration.
  • An entrie process of application and approval procedures for clinical trials of imported drug registration.
  • The full text in English of "Drug Registration Application Form for Imported Drug".
  • The practical guidance for clinical trials of imported chemical drug registration, from the general and special regulations on clinical trials for imported chemical drug registration, the requirements for data and materials of application for approval of clinical trials for imported chemical drugs to the data and materials submission of application for approval of clinical trials for imported chemical drugs to smoothly navigate complex regulatory requirements step by step.
  • The practical guidance for clinical trials of imported biological product registration, also from the general and special regulations on clinical trials for imported biological product registration, the requirements for data and materials of application for approval of clinical trials for imported biological products to the data and materials submission of application for approval of clinical trials for imported biological products to smoothly navigate complex regulatory requirements step by step..
  • The practical guidance for clinical trials of imported natural medicine and traditional Chinese medicine registration, again from the general and special regulations on clinical trials for imported natural medicine and traditional Chinese medicine registration, the requirements for data and materials of application for approval of clinical trials for imported natural medicines and traditional Chinese medicines to the data and materials submission of application for approval of clinical trials for imported natural medicines and traditional Chinese medicines to smoothly navigate complex regulatory requirements step by step..
  • A set of full text in English of Chinese laws and regulations for pharmaceutical product clinical trials.

Who should buy this report?

  • Overseas pharmaceutical companies wishing to enter into the Chinese drug market.
  • Multinational pharmaceutical companies have penetrated into the Chinese drug market.
  • Companies interested in understanding the latest Chinese laws and regulations for pharmaceutical product clinical trials.
  • Senior executive officers engaging in regulatory affairs for imported drugs into Chinese lucrative drug market.
  • Senior executive officers engaging in conducting clinical trials for imported drugs in China.

Table of Contents

Chapter 1 Executive Summary

Chapter 2 Chinese Applicable Laws and Regulations for Drug Clinical Trials

Chapter 3 An Overview of Chinese Authorities for Drug Clinical Trials

  • 3.1. CFDA's Main Responsibilities
  • 3.2. CFDA's Organizational Structure
    • Figure 3.2.1. CFDA's Organizational Structure
    • Table 3.2.1. CFDA's affiliated organizations
  • 3.3. Roadmap of Application and Approval for Clinical Trials of Imported Drug Registration
    • Figure 3.3.1. Roadmap of Application and Approval for Clinical Trias of Imported Drug Registration

Chapter 4 Knowledge Preparation before conducting Imported Drug Clinical Trials

  • 4.1. Definitions.
  • 4.2. Classification of Drugs
    • 4.2.1. Classification of Chemical Drugs
    • 4.2.2. Classification of Biological Products
      • 4.2.2.1. Classification of Therapeutic Biological Products
      • 4.2.2.2. Classification of Prophylactic Biological Products.
    • 4.2.3. Classification of Natural Medicines and Traditional Chinese Medicines (TCMs)

Chapter 5 General Regulations on Application and Approval for Clinical Trials of Imported Drug Registration.

  • 5.1. General Regulations on Application and Approval for Clinical Trials of Imported Drug Registration
  • 5.2. Special Regulations for Imported Drug Clinical Trials.

Chapter 6 Every Party's Responsibilities in Clinical Trials for Imported Drug Registration

  • 6.1. The Sponsor's Responsibilities
  • 6.2. The Monitor's Responsibilities
  • 6.3. The Ethics Committee's Responsibilities
  • 6.4. The Investigator's Responsibilities.

Chapter 7 Application and Approval Procedures for Clinical Trials of Imported Drug Registration

  • Figure 7.1. An Entrie Process of Application and Approval Procedures for Imported Drug Registration
  • Figure 7.2. Application and Approval Procedure for Clinical Trials

Chapter 8 Application Form for Imported Drug Registration

  • 8.1. Drug Registration Application Form for Imported Drug
    • Table 8.1. Drug Registration Application Form for Imported Drug
  • 8.2. Explanatory Notes for filling Drug Registration Application Form for Imported Drug

Chapter 9 Practical Guidance for Clinical Trials of Imported Chemical Drug Registration

  • 9.1. General Regulations on Clinical Trials for Chemical Drug Registration
  • 9.2. Special Regulations for Imported Chemical Drug Clinical Trials
  • 9.3. Data and Materils of Application for Approval of Clinical Trials for Imported Chemical Drug Registration
    • 9.3.1. Data Items of Application for Approval of Imported Chemical Drug Clinical Trials
    • 9.3.2. Requirements for Data and Materials of Application for Approval of Imported Chemical Drug Clinical Trials
    • 9.3.3. Explanatory Notes for Data and Materials of Application for Approval of Imported Chemical Drug Clinical Trials
    • 9.3.4. Data and Materials submission of Application for Approval of Imported Chemical Drug Clinical Trials.

Chapter 10 Practical Guidance for Clinical Trials of Imported Biological Product Registration

  • 10.1. Practical Guidance for Clinical Trials of Imported Therapeutic Biological Product Registration
    • 10.1.1. General Regulations on Clinical Trials for Imported Therapeutic Biological Product Registration
    • 10.1.2. Special Regulations for Imported Therapeutic Biological Product Clinical Trials.
    • 10.1.3. Data and Materils of Application for Approval of Clinical Trials for Imported Therapeutic Biological Product Registration
    • 10.1.4. Requirements for Data and Materials of Application for Approval of Imported Therapeutic Biological Product Clinical Trials
    • 10.1.5. Explanatory Notes for Data and Materials of Application for Approval of Imported Therapeutic Biological Product Clinical Trials.
    • 10.1.6. Data and Materials submission of Application for Approval of Imported Therapeutic Biological Product Clinical Trials
  • 10.2. Practical Guidance for Clinical Trials of Imported Preventive Biological Product Clinical Trials
    • 10.2.1. General Regulations on Clinical Trials for Preventive Biological Product Registration
    • 10.2.2. Special Regulations for Imported Preventive Biological Product Clinical Trials
    • 10.2.3. Data and Materils of Application for Approval of Clinical Trials for Imported Preventive Biological Product Registration
    • 10.2.4. Requirements for Data and Materials of Application for Approval of Imported Preventive Biological Product Clinical Trials
    • 10.2.5. Explanatory Notes for Data and Materials of Application for Approval of Imported Preventive Biological Product Clinical Trials
    • 10.2.6. Data and Materials submission of Application for Approval of Imported Preventive Biological Product Clinical Trials.

Chapter 11 Practical Guidance for Clinical Trials of Imported Natural Medicine and Traditional Chinese Medicine Registration

  • 11.1. General Regulations on Clinical Trials for Natural Medicine and Traditional Chinese Medicine Registration.
  • 11.2. Special Regulations for Clinical Trials of Imported Natural Medicine and Traditional Chinese Medicine Registration
  • 11.3. Data and Materils of Application for Approval of Clinical Trials for Imported Natural Medicine and Traditional Chinese Medicine Registration
  • 11.4. Requirements for Data and Materials of Application for Approval of Clinical Trials for Imported Natural Medicines and Traditional Chinese Medicines
  • 11.5. Explanatory Notes for Data and Materials of Application for Approval of Clinical Trials of Imported Natural Medicines and Traditional Chinese Medicines
  • 11.6. Data and Materials Submission of Application for Approval of Clinical Trials of Imported Natural Medicines and Traditional Chinese Medicines

Chapter 12 Appendices

  • 12.1. The Drug Administration Law of the People's Republic of China.
  • 12.2. The Regulations for Implementation of the Drug Administration Law of the People's Republic of China.
  • 12.3. The Good Clinical Practice of Pharmaceutical Products
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