株式会社グローバルインフォメーション
TEL: 044-952-0102
市場調査レポート

中国国内での医薬品の国際多施設共同治験に関する最新の規制

Latest Regulations on Pharmaceutical International Multi-Center Clinical Trials in China

発行 Access China Management Consulting 商品コード 326157
出版日 ページ情報 英文 101 Pages
即納可能
価格
本日の銀行送金レート: 1USD=114.58円で換算しております。
Back to Top
中国国内での医薬品の国際多施設共同治験に関する最新の規制 Latest Regulations on Pharmaceutical International Multi-Center Clinical Trials in China
出版日: 2015年03月19日 ページ情報: 英文 101 Pages
概要

中国の医薬品市場は世界の大手製薬企業にとって無視できない存在ですが、国内の治験規制は現在、大幅な改定の最中にあります。中国当局は2015年3月1日より、国際多施設共同治験に関するガイドラインを正式に公表する予定です。将来有望な中国市場に参入するためには、外資系の製薬企業はこのガイドラインを遵守する必要があります。また、各社の規制担当役員はこのガイドラインについて熟知し、最新の規制に従って治験を進めていく必要があります。

当レポートでは、中国国内における国際・多施設共同治験の実施・申請・認証の過程や関連規制の概要について分析し、中国国内の治験の監督体制や、国際多施設共同治験に関する一般的・科学的・コンプライアンス上の留意点、実際の治験の実施・申請・認証過程、中国国内での申請・認証ガイドラインや実際上の注意点といった情報を取りまとめてお届けいたします。

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連の規制当局の概要

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

第3章 背景事情

第4章 適用範囲

第5章 一般的要件

  • 医薬品の国際多施設共同治験の基本的な条件
  • 医薬品の国際多施設共同治験に関する戦略選定
  • 中国国内での医薬品登録に際しての、国際多施設共同治験データの受容要件

第6章 科学的問題に関する考察

  • 疾患の疫学
  • 医療行為の違い
  • 薬物代謝の違い
  • 服用量の選定
  • 対照薬の選定
  • 効能の評価指標
  • サンプルサイズに関する考察
  • 統計データに関する考察
  • 有害事象/副作用の情報収集と評価
  • その他の考慮すべき課題

第7章 コンプライアンス上の課題に関する考察

  • 治験認可の申請と情報公開
  • 倫理委員会の認可
  • 文章用の言語
  • インフォームド・コンセント
  • 情報の提出
  • 治験対象者への報酬
  • 治験薬に関する情報
  • 生体試料
  • データ処理センター
  • 有害事象 (AE) の情報収集・評価
  • コンピューターシステムの活用
  • 治験センターのモニタリング・検証

第8章 治験プロトコルの修正

第9章 医薬品登録のための申請

第10章 現地での審査・認証

第11章 中国国内での医薬品の国際多施設共同治験の申請・認証に関する実践的なガイドライン

  • 中国国内での医薬品の国際多施設共同治験の申請・認証に関する事前知識
    • 外国企業が中国で医薬品の国際多施設共同治験を申請する際の特殊規制
    • 難病・重病の治療用新薬/革新的医薬品に関する、特別な検証・認証過程
    • 中国で国際多施設共同治験により申請される医薬品の種類
  • 中国国内での医薬品の国際多施設共同治験の申請・認証に関する実践的なガイドライン
    • 中国での医薬品の国際多施設共同治験の申請・認証に先立つ準備
    • 中国での医薬品の国際多施設共同治験の申請・認証に関する特殊条項
    • 中国での医薬品の国際多施設共同治験の申請・認証の実際の運用状況
    • 中国国内での医薬品の国際多施設共同治験の申請・認証過程
    • 中国国内の医薬品の国際多施設共同治験に関する規制と情報公開

第12章 包括的分析

  • 中国での医薬品の国際多施設共同治験に関する機会と課題
  • 中国での医薬品の国際多施設共同治験に関する機会とは何か?
  • 中国での医薬品の国際多施設共同治験に関する課題とは何か?

第13章 付録

  • 付録1:新薬登録の特殊検査・認証のための申請フォーム
  • 付録2:新薬登録のための特殊検査・認証の伝達のための申請フォーム
  • 付録3:医薬品登録の申請フォーム
目次
Product Code: ACMC201503008

China's healthcare market is indispensable for overseas and multinational pharmaceutical companies, but Chinese regulations on pharmaceutical clinical trials are undergoing sharp changes. This is first time in history, Chinese pharmaceutical authorities officially issued a guidance on international multi-center clinical trials of drugs in China, which has begun to be implemented on March 1, 2015. To enter into Chinese lucrative drug market, the overseas and multinational pharmaceutical manufacturers must be compliance with this latest regulations. How do respond such challenges? The overseas and multinational pharmaceutical anufacturers and their senior executive officers engaging in regulatory affairs must have a comprehensive and thorough knowledge of the Guidance on Chinese international multi-center clinical trials of drugs, and must be compliance with the latest regulations.

Latest Regulations on Pharmaceutical International Multi-Center Clinical Trials in China provided a comprehensive and thorough knowledge of the Guidance on international multi-center clinical trials of drugs in China and guide you use the Chinese trial venues to keep drug development lean and to smoothly operate in China step by step.

The organizations of this guidebook are arranged as follows. Chapter 2 provides an overview of the Chinese regulatory authorities -- China Food and Drug Administration (CFDA) being responsible for application and approval for international multi-center clinical trials of drug registration to give the direction of gateway for application for approval of clinical trial of imported overseas drug registration. Chapter 3 elaborates the background of promulgating Guidance. Chapter 4 introduces the applicable scope of Guidance. Chapter 5 introduces the general requirements of international multi-center clinical trials of drugs in China. Chapter 6 elaborates a series of scientific issues that Guidance requires sponsors to be considered. Chapter 7 elaborates a series of compliance issues that Guidance requires sponsors to be considered. Chapter 8 elaborates the clinical trial protocol amendment. Chapter 9 introduces the requirements for using the data from international multi-center clinical trials to support the application for drug registration in China. Chapter 10 introduces the authority, objects, contents, scope and requirements of Chinese drug regulatory authorities implementing inspection and verification on clinical trial sites. Chapter 11 provides a comprehensively and thoroughly practical guidance for application and approval of pharmaceutical international multi-center clinical trials in China, from the knowledge preparation and operation preparation before application, the specific regulations on overseas applicant and application, to the practical operation of application for approval as well as registration and information disclosure of international multi-center clinical trials of drugs in China to smoothly navigate complex regulatory requirements step by step. Chapter 12 provides a comprehensively comparative analysis to reveal the opportunities and challenges of international multi-center clinical trials of drugs in China, and to tell overseas and multinational pharmaceutical companies how to respond challenges. Chapter 13 Appendices provide a complete set of full text in English of application forms involved in application for approval of pharmaceutical international multi-center clinical trials in China, which include "Application Form of Drug Registration", "Application Form for Special Examination and Approval of New Drug Registration", and "Application Form for Communication of Special Examination and Approval of New Drug Registration".

The audiences of this guidebook are overseas pharmaceutical manufacturers 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 apply for international multi-center clinical trials and registration of their pharmaceutical products in China, how to comply with the latest guidance on international multi-center clinical trials of drugs in China.

After having skimmed through this guidebook, audiences can clearly acquire not only a comprehensive and thorough knowledge of the latest guidance on international multi-center clinical trials of drugs in China but also the practical operation how to comply with the latest guidance on international multi-center clinical trials of drugs in China. 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 products in China.

Report Highlights

  • l An overview of organizational structure of Chinese regulatory authorities -- China Food and Drug Administration (CFDA) for approval for international multi-center clinical trials in China to give the direction of gateway for clinical trials of imported drugs.
  • l The background of promulgating Guidance.
  • l The applicable scope of Guidance.
  • l The general requirements of international multi-center clinical trials of drugs in China.
  • l A series of scientific issues that overseas sponsors must be considered.
  • l A series of compliance issues that overseas sponsors must be considered.
  • l The detailed requirements for using the data from international multi-center clinical trials to support the application for imported overseas drug registration in China.
  • l Chinese drug regulatory authorities how to implement the inspection and verification on clinical trial sites.
  • l A comprehensively and thoroughly practical guidance for application and approval of pharmaceutical international multi-center clinical trials in China, from the knowledge preparation and operation preparation before application, the specific regulations on overseas applicant and application, to the practical operation of application for approval as well as registration and information disclosure of international multi-center clinical trials of drugs in China to smoothly navigate complex regulatory requirements step by step.
  • l An entrie process of application and approval procedures for international multi-center clinical trials of drugs in China.
  • l The detailed regulations on registration and information disclosure for international multi-center clinical trials of drugs in China.
  • l A comprehensively comparative analysis to reveal the opportunities and challenges of international multi-center clinical trials of drugs in China, and to tell overseas and multinational pharmaceutical companies how to respond challenges.
  • l A complete set of full text in English of application forms involved in application for approval of pharmaceutical international multi-center clinical trials in China, which include "Application Form of Drug Registration", "Application Form for Special Examination and Approval of New Drug Registration", and "Application Form for Communication of Special Examination and Approval of New Drug Registration".

Table of Contents

Chapter 1 Executive Summary

Chapter 2 An Overview of Chinese Regulatory Authorities for Drug Clinical Trials

  • 2.1. CFDA's Main Responsibilities
  • 2.2. CFDA's Organizational Structure
    • Figure 2.2.1. CFDA's Organizational Structure
    • Table 2.2.1. CFDA's affiliated organizations
  • 2.3. Roadmap of Application and Approval for Clinical Trials of Imported Drug Registration
    • Figure 2.3.1. Roadmap of Application and Approval for Clinical Trias of Imported Drug Registration

Chapter 3 Background

Chapter 4 Applicable Scope

Chapter 5 General Requirements

  • 5.1. Basic Conditions of International Multi-center Clinical Trials for Drugs
  • 5.2. Belection of Strategies for International Multi-center Clinical Trials of Drugs
  • 5.3. Requirements for Accepting International Multi-center Clinical Trial Data for Drug Registration in China

Chapter 6 Consideration for Scientific Issues

  • 6.1. Epidemiology of Disease
  • 6.2. Differences in Medical Practice
  • 6.3. Differences in Drug Metabolism
  • 6.4. Selection of Dose
  • 6.5. Selection of Control Drugs
  • 6.6. Assessment Indexes of Efficacy
  • 6.7. Consideration for Sample Size
  • 6.8. Consideration for Statistics
  • 6.9. Collection and Assessment of Adverse Events / Reactions
  • 6.10. Other Consideration Issues

Chapter 7 Consideration for Compliance Issues

  • 7.1. Application for Approval of Clinical Trials and Information Publicity
  • 7.2. Approval of Ethics Committee
  • 7.3. Language of Documents
  • 7.4. Informed Consent
  • 7.5. Information Submission
  • 7.6. Compensation to Trial Subjects
  • 7.7. Information about Clinical Trial Drug
  • 7.8. Biological Samples
  • 7.9. Data Processing Centers
  • 7.10. Collection and Assessment of Adverse Events (AE
  • 7.11. Application of Computerized System
  • 7.12. Monitoring and Verifying for Clinical Trial Centers

Chapter 8 Clinical Trial Protocol Amendment

Chapter 9 Application for Drug Registration

Chapter 10 Inspection and Verification on Sites

Chapter 11 Practical Guidance for Application and Approval of Pharmaceutical International Multi-Center Clinical Trials in China

  • 11.1. Knowledge Preparation before Application for Approval of International Multi-Center Clinical Trials of Drugs in China
    • 11.1.1. Specific Regulations on Overseas Applicant to Apply for International Multi-Center Clinical Trials of Drugs in China
    • 11.1.2. Special Examination and Approval Procedures for Innovative Drugs, New Drugs for Treatment of Difficult and Critical Diseases
    • 11.1.3. What Pharmaceutical Products may be Applied for International Multi-Center Clinical Trials in China
  • 11.2. Practical Guidance for Application and Approval of Pharmaceutical International Multi-Center Clinical Trials in China
    • 11.2.1. Preparation before Application for Approval of International Multi-Center Clinical Trials of Drugs in China
    • 11.2.2. Specific Provisions on Application for Approval of International Multi-Center Clinical Trials of Drugs in China
    • 11.2.3. Practical Operation of Application for Approval of International Multi-Center Clinical Trials of Drugs in China
    • 11.2.4. Application and Approval Procedure for International Multi-Center Clinical Trials of Drugs in China
      • Figure 11.2.4. Application and Approval Procedure for International Multi-Center Clinical Trials of Drugs in China
    • 11.2.5. Registration and Information Disclosure for International Multi-Center Clinical Trials of Drugs in China

Chapter 12 A Comprehensive Analysis

  • Opportunities and Challenges of International Multi-Center Clinical Trials of Drugs in China
  • 12.1. What are Opportunities of International Multi-Center Clinical Trials in China?
    • Figure 12.1. Quantity of Clinical Trials in Chinese Region Registered on ClinicalTrial.gov
    • Figure 12.2. Quantity of Global Clinical Trials Registered on ClinicalTrial.gov
  • 12.2.What are Challenges of International Multi-Center Clinical Trials in China?
    • Table 12.2. Approval Timeframe and Regulatory System for Clinical Trials

Chapter 13 Appendices.80

  • Appendix 1 Application Form for Special Examination and Approval of New Drug Registration
  • Appendix 2 Application Form for Communication of Special Examination and Approval of New Drug Registration
  • Appendix 3 Application Form of Drug Registration
Back to Top