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市場調查報告書

中國實施醫藥品臨床試驗的最新指南:從法規到實施

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

出版商 Access China Management Consulting 商品編碼 308353
出版日期 內容資訊 英文 191 Pages
商品交期: 最快1-2個工作天內
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中國實施醫藥品臨床試驗的最新指南:從法規到實施 Latest Guidebook for Conducting Pharma Clinical Trials in China: From Regulations to Practice (2014 Edition)
出版日期: 2014年08月25日 內容資訊: 英文 191 Pages
簡介

中國是全球最大的醫療市場之一。由於持續性的經濟、人口成長及人口的高齡化,中國的醫療市場在1990年代之後,維持16%以上的年度平均成長率。至2013年中國的醫療市場上醫藥品總額達到1兆1,140億人民幣。中國的醫療市場上,海外、跨國醫藥品廠商製造的進口藥佔4分之一。中國的醫療市場上醫藥品總額預期到2015年達1兆4,500億人民幣以上,成為超過日本次於美國的全球第2大醫藥品市場。許多海外、跨國醫藥品廠商為了在這個醫藥品市場上取得大機會,在中國實施醫藥品臨床實驗。可是,遵守中國的GCP(醫藥品臨床試驗實施標準)的方法獨特,海外、跨國醫藥品廠商需要具有臨床實驗相關最新的中國法規知識。

本報告提供中國的進口藥登記前的臨床實驗相關最新的相關法規資訊、中國的GCP(醫藥品臨床試驗實施標準)指導等彙整資料,為您概述為以下內容。

第1章 摘要整理

第2章 中國的醫藥品臨床實驗關係法規

第3章 中國的醫藥品臨床實驗當局概要

  • CFDA(中國國家食品藥品監督管理局)的主要責任
  • CFDA的組織結構
  • 進口醫藥品登記的臨床實驗申請、認證發展藍圖

第4章 實施進口醫藥品臨床實驗之前準備的資訊

  • 定義
  • 醫藥品的分類

第5章 進口醫藥品登記臨床實驗申請、認證相關一般的法律

  • 進口醫藥品登記臨床實驗申請、認證相關一般的法律
  • 進口醫藥品臨床實驗特定的法規

第6章 進口醫藥品登記臨床實驗的全相關人員的責任

  • 贊助商的責任
  • 螢幕的責任
  • 倫理委員會的責任
  • 臨床實驗責任醫生的責任

第7章 進口醫藥品登記臨床實驗的申請、認證次序

第8章 進口醫藥品登記的申請表格

  • 進口醫藥品登記的申請表格
  • 進口醫藥品登記的申請表格記入的註記

第9章 進口化學藥品登記用臨床實驗的實用指導

  • 進口化學藥品登記用臨床實驗的一般法規
  • 進口化學藥品登記用臨床實驗的特定法規
  • 進口化學藥品登記用臨床實驗的數據、資料

第10章 進口生物製藥登記用臨床實驗的實用指導

  • 治療生物製藥
  • 預防生物製藥

第11章 進口生藥、中藥登記用臨床實驗的實用指導

  • 進口生藥、中藥登記用臨床實驗的一般法規
  • 進口生藥、中藥登記用臨床實驗的特定法規
  • 進口生藥、中藥登記用臨床實驗的數據、資料
  • 進口生藥、中藥登記用臨床實驗的數據、資料必要條件
  • 進口生藥、中藥登記用臨床實驗的數據、資料的註記
  • 進口生藥、中藥登記用臨床實驗的數據資料的提交

第12章 附錄

目錄
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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