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中国の輸入薬剤登録申請・承認のための書類および治験要求事項:輸入化学薬剤の登録申請ガイドブック

China Pharmaceutical Guidebook Series (2) 2013 - Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Chemical Drugs

発行 Access China Management Consulting 商品コード 196754
出版日 ページ情報 英文 121 Pages
納期: 即日から翌営業日
価格
本日の銀行送金レート: 1USD=101.55円で換算しております。
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中国の輸入薬剤登録申請・承認のための書類および治験要求事項:輸入化学薬剤の登録申請ガイドブック China Pharmaceutical Guidebook Series (2) 2013 - Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Chemical Drugs
出版日: 2013年04月20日 ページ情報: 英文 121 Pages
概要

2012年に中国の医薬品市場は、9,261億人民(およそ1470億米ドル)に達したと推計されており、2015年には世界第2位の規模に達する見通しです。中国では欧米諸国と同様に、医薬品当局であるSFDAが申請者に薬剤登録のための複雑かつ信頼性の高い書類の提出を求めています。

当レポートでは、中国の医薬品ガイドブックシリーズとして、放射性薬品を含め、SFDAによる輸入化学薬剤の登録申請書類および治験要求事項について詳細に検証し、その概要と分野別の要件などをまとめ、概略下記の構成でお届けいたします。

第1章 イントロダクション

第2章 薬剤登録の分類

第3章 薬剤登録申請書類項目

  • 包括的書類
  • 薬剤学研究資料
  • 薬理学、毒性学研究資料

第4章 薬剤登録申請のための書類要求事項

  • 書類の書式
  • 注釈

第5章 薬剤登録申請のための治験要求事項

  • 治験の一般的要求事項
  • 輸入薬剤の治験に関する特別要求事項

第6章 放射性医薬品のための書類と治験要求事項

  • 定義
  • 書類項目要件
  • 注釈
  • 治験要件

第7章 結論

第8章 付録

  • 中国の薬剤投与法
  • 中国の薬剤投与法の実施規定
  • 医薬品のためのGCP
  • 輸入薬剤の登録申請書式
  • 参考情報
  • 企業紹介

このページに掲載されている内容は最新版と異なる場合があります。詳細はお問い合わせください。

目次
Product Code: ACMC 201304002

China possesses a fourth population in the world and has one of the largest drug markets round the world. By 2012, sales on the Chinese drug market have reached RMB 926.1billion (about US$147 billion) reported by the « 2012: Report of China Pharmaceutical Market» published by Chinese Academy of Social Sciences. It is estimated that it will exceed RMB 1,000 billion by 2013. A series of factors, such as an increasingly ageing population, accelerating growth of urban population as well as expansion of healthcare covering urban and rural, will grow the Chinese drug market with a growth rate over 20 percent per annum in next three years. China is expected to become the second largest drug market in the world by 2015.

Since the reform and open door policy implemented by Chinese authorities in the late 1970s, the door of the Chinese drug market began opening up to the world step by step, which gave a fillip to the imported drugs from overseas pharmaceutical manufacturers and producers. By 2012, sales of imported drugs have shared one fourth on the Chinese drug market. As China joins the World Trade Organization (WTO) and integrates more completely into the global economy, it will further open the door of a lucrative drug market for overseas pharmaceutical companies. More and more overseas pharmaceutical manufacturers and producers expect to enter such drug market and seize a larger part of such drug market. To enter such a lucrative drug market, the first obstacle faced by overseas pharmaceutical manufacturers and producers is how to file the application for their imported drug registration with Chinese pharmaceutical authorities.

In China, the process of application and approval for imported drug registration is very complex, because the Chinese pharmaceutical authorities administer and control this process by exorbitant administrative measures and regulations, moreover, these exorbitant administrative regulations are variable and lack of transparency. Therefore, a comprehensive and thorough knowledge of the latest Chinese regulations for imported drug registration has been become an essential prerequisite for overseas pharmaceutical manufacturers and producers to achieve a successful application for their products entry into the Chinese drug market. In despite of since the drug registration implemented by the Chinese pharmaceutical authorities on December 1, 2002, its regulatory regime has experienced countless changes, and become increasingly compatible with international standards, in turn, its ongoing consolidation will eventually contribute to a healthier market environment. The Chinese Pharmaceutical authority promulgated the last “Measures for the Administration of Drug Registration” on July 10 2007, and the last “Measures” entered into force since October 1, 2007. However, the practical operations for application and approval of imported drug registration have been constantly changed, because the amendment of Measures” is delayed. Under such circumstance, Access China Management Consulting Ltd published the China Pharmaceutical Guidebook Series: 2013 Edition. The aim of this guidebook series is to guide overseas pharmaceutical manufacturers and producers to achieve a successful application and approval for their imported drug registration.

This guidebook series are composed of four guidebooks as the following:

    Latest Chinese Regulations for Imported Drug Registration: 2013 Edition

    A Comprehensive Guidebook for Foreign Pharmaceutical Companies

     

    Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: 2013 Edition

    A Guidebook for Application of Imported Chemical Drugs Registration

     

    Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: 2013 Edition

    A Guidebook for Application of Imported Biological Product Registration

     

    Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: 2013 Edition

    A Guidebook for Application of Imported Traditional Chinese Medicine and Natural Medicine Registration

In this guidebook series, overseas pharmaceutical manufacturers and producers can easily find out every answer that they will meet question during process of application and approval for their imported drug registration. Access China Management Consulting Ltd hopes this China Pharmaceutical Guidebook Series, based on full and accurate regulations and law, can help guide overseas pharmaceutical manufacturers and producers to achieve a successful application and approval for their imported drug registration in China.

Executive Summary

This is the second guidebook of the China Pharmaceutical Guidebook Series. It will provide a detailed introduction of SFDA's requirements for materials and clinical trials of application and approval for imported chemical drug registration, including radioactive pharmaceuticals.

Report Highlights

  • An overview of the classification of drug registration formulated by the SFDA (The State Food and Drug Administration in China).
  • The material items for application of drug registration.
  • The requirements of material items for application of drug registration.
  • The requirements of clinical trial for application of drug registration.
  • The material and clinical trial requirements for application of radioactive pharmaceuticals
  • The significant suggestions for overseas pharmaceutical manufacturers and producers looking to achieve a successful application for their chemical drug registration in China.
  • Many useful resources of law and regulations, including the Drug Administration Law of the People's Republic of China, the Regulations for Implementation of the Drug Administration Law of the People's Republic of China, the Chinese Good Clinical Practice of Pharmaceutical Products, the Form of Registration Application for Imported Drug, and so on.

Table of Contents

Table of Contents

Preface

Chapter 1. Introduction

Chapter 2. Classification of Drug Registration

Chapter 3. Material Items for Application of Drug Registration

  • 3.1. Summary Materials
  • 3.2. Research Materials of Pharmaceutics
  • 3.3. Research Materials of Pharmacology and Toxicology
  • 3.4. Materials of Clinical Investigation

Chapter 4. Requirements of Material Items for Application of Drug Registration

  • 4.1. The Form of Material Items
  • 4.2. The Explanatory Notes of Material Items

Chapter 5. Requirements of Clinical Trial for Application of Drug Registration

  • 5.1. General Requirements of Clinical Trial
  • 5.2. Special Requirements of Clinical Trial for Imported Drugs

Chapter 6. Material and Clinical Trial Requirements for Radioactive Pharmaceuticals

  • 6.1. Definitions
  • 6.2. Requirements of Material Items
  • 6.3. Explanatory Notes of Material Items
  • 6.4. Requirements of Clinical Trial

Chapter 7. Conclusion

Chapter 8. Appendices

  • 8.1. The Drug Administration Law of the People's Republic of China
  • 8.2. The Regulations for Implementation of the Drug Administration Law of the People's Republic of China
  • 8.3. The Good Clinical Practice of Pharmaceutical Products
  • 8.4. Form of Registration Application for Imported Drug
  • 8.5. References
  • 8.6. Company's Description
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