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中国の医薬品ガイドブックシリーズ−輸入医薬品登録の出願・承認のための資料・治験要件:輸入生物製剤の登録出願ガイドブック

China Pharmaceutical Guidebook Series (3) 2013 - Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Biological Products

発行 Access China Management Consulting 商品コード 269863
出版日 ページ情報 英文 168 Pages
納期: 即日から翌営業日
価格
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中国の医薬品ガイドブックシリーズ−輸入医薬品登録の出願・承認のための資料・治験要件:輸入生物製剤の登録出願ガイドブック China Pharmaceutical Guidebook Series (3) 2013 - Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Biological Products
出版日: 2013年05月10日 ページ情報: 英文 168 Pages
概要

中国は世界最大の医薬品市場のひとつです。同市場は2012年までに9,261億人民元(約1470億米ドル)に達し、2013年までに1兆人民元を突破すると予測されています。

当レポートでは、中国における治療用生物製剤、予防生物製剤、遺伝子治療・体細胞治療およびアレルギー治療用生物製剤の輸入薬登録出願のガイドラインを示しており、必要書類や治験の要件など、概略以下の構成でお届けします。

序文

第1章 イントロダクション

第1部 治療用生物製剤

第2章 治療用生物製剤登録の分類

第3章 治療用生物製剤登録の出願用書類

  • 要約資料
  • 医薬品の研究資料
  • 薬理学・毒物額の研究資料
  • 臨床試験の資料
  • 付属資料

第4章 治療用生物製剤登録の出願書類要件

  • 書類形式
  • 資料の注釈メモ

第5章 治療用生物製剤登録出願用臨床試験の要件

  • 臨床試験の一般的な要件
  • 治療用輸入生物製剤臨床試験の特殊要件

第2部 予防生物製剤

第6章 予防生物製剤登録の分類

第7章 予防生物製剤登録の出願書類

  • 要約資料
  • 研究結果の要約と評価
  • 使用細菌(毒性)株の研究資料
  • 使用細胞マトリクスの研究資料
  • 品質研究の実験試料、および前臨床効能・安全性の研究資料
  • 生産・分析のレギュレーションドラフト、レギュレーションのドラフティング説明、関連文献
  • 臨床試験申請用のサンプル生産・分析の記録
  • 初期安定性研究の研究資料
  • 生産、研究および臨床試験に用いた動物の品質証明
  • 臨床試験の計画・スキーム
  • 前臨床試験のサマリー
  • 臨床試験関連文献のサマリー
  • 臨床試験レポート、インフォームドコンセント形式のドラフト、倫理委員会の承認状
  • 生産技術および品質基準改善のワーキングサマリー、臨床試験中の薬理学・毒物額研究の実験資料
  • ワクチンの保存状態・有効期間決定の調査資料
  • 生産・分析の修正コンテンツ・見直された規制の根拠
  • 試作品の成功バッチ3件の生産・分析の記録

第8章 予防生物製剤登録の出願書類要件

  • 書類形式
  • 資料の注釈メモ

第9章 予防生物製剤登録出願用臨床試験の要件

  • 臨床試験の一般的な要件
  • 輸入予防生物製剤臨床試験の特殊要件

第3部 遺伝子治療・体細胞治療の出願ガイドライン

第10章 遺伝子治療用生物製剤の出願ガイドライン

  • 資料の要約
  • 製剤のプロジェクト・品質管理の調査コンテンツ
  • 研究プロジェクト・製剤の臨床試験

第11章 体細胞治療用生物製剤の出願ガイドライン

  • 資料の要約
  • 製剤の品質管理
  • 臨床試験

第4部 アレルギー治療用生物製剤

第12章 アレルギー治療用生物製剤の出願ガイドライン

  • 製剤の品質管理
  • 前臨床試験の要件
  • 臨床試験の要件

第13章 結論

第14章 付録

目次
Product Code: ACMC201305002

Abstract

A Guidebook of Registration Application for Imported Biological Products provides a comprehensive and thorough knowledge of application for imported biological product registration with the Chinese drug regulatory authorities to guide overseas pharmaceutical manufacturers and producers to achieve a successful application for their products entry into the Chinese drug market.

Preface

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

The biopharmaceutical industry is one of the burgeoning industries. In the field of biopharmaceuticals, vast knowledge awaits people to explore. The biopharmaceuticals are diversified and complex. In China, the development of biopharmaceutical industry is far behind the developed countries. The requirements of materials and clinical trials for registration application of biopharmaceuticals stipulated by the Chinese pharmaceutical authority are far from systematic and harmonized.

In China, the pharmaceutical regulatory authority ----- the SFDA (State Food and Drug Administration, China) divided the biopharmaceuticals for registration application into two classifications, i.e. the therapeutic biological products and the prophylactic biological products. However, in the classification of therapeutic biological products, the SFDA does not provide the uniform requirements of materials and clinical trials for application of biological products for the gene therapy, the somatic cell therapy and the allergic therapy, but stipulates the other guidelines for them respectively. These guidelines provide only a general principle for them because of their diversity and complexity. Just for this reason, a comprehensive and thorough knowledge of the latest Chinese regulations for imported biological product registration is particularly important for overseas pharmaceutical manufacturers and producers to achieve a successful application for their products entry into the Chinese drug market.

This is the third guidebook of the China Pharmaceutical Guidebook Series. It provides a detailed introduction of SFDA's requirements for materials and clinical trials of registration application and approval for imported biological products. This guidebook will introduce SFDA's requirements for materials and clinical trials of registration application for imported biological products in four parts and twelve chapters according to the existing a serial of regulations and guidelines. The Part I provides an introduction of the requirements for materials and clinical trials of registration application for imported therapeutic biological products. The Part II introduces the requirements for materials and clinical trials of registration application for imported prophylactic biological products. The Part III addresses the requirements for materials and clinical trials of registration application for imported gene therapeutic biological products and somatic cell therapeutic biological products. The Part IV addresses the requirements for materials and clinical trials of registration application for imported allergic therapeutic biological products.

The guidebook concludes in chapter 13 by highlighting the significant suggestions for overseas pharmaceutical manufacturers and producers looking to achieve a successful application for their biopharmaceuticals registration in China. Last, the appendices in chapter 14 include the Drug Administration Law of the People's Republic of China, the Regulations for the 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, references, and description of Access China Management Consulting Ltd. After have skimmed through this guidebook, audience can be clearly aware of the latest Chinese regulations on requirements of the materials and the clinical trials for registration application of imported biological products. For the detailed pathway and procedure for application and approval of imported biological products, audience can learn from the first guidebook of the China Pharmaceutical Guidebook Series (2013 Edition) ---- Latest Chinese Regulations for Imported Drug Registration: A Comprehensive Guidebook for Foreign Pharmaceutical Companies.

Report Highlights

  • The classification of biological product registration
  • The material items for application of biological product registration
  • The requirements of material items for application of biological product registration
  • The requirements of clinical trial for application of biological product registration
  • The guideline for application of biological products for human gene therapy
  • The guideline for application of biological products for somatic cell therapy
  • The guideline for application of biological products for allergic therapy
  • The significant suggestions for overseas pharmaceutical manufacturers and producers looking to achieve a successful application for their biopharmaceuticals 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.

Who should buy this report?

  • Companies wishing to enter a lucrative drug market in China.
  • Companies interested in understanding the latest Chinese regulations on application and approval for imported drug registration.
  • Senior executive officers engaging regulatory and registration affairs for drugs.

Table of Contents

Preface

Chapter 1. Introduction

Part 1. Therapeutic Biological Products

Chapter 2. Classification of Therapeutic Biological Product Registration

Chapter 3. Material Items for Application of Therapeutic Biological Product 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
  • 3.5. Miscellaneous

Chapter 4. Requirements of Material Items for Application of Therapeutic Biological Product 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 Therapeutic Biological Product Registration

  • 5.1. General Requirements of Clinical Trial
  • 5.2.Special Requirements of Clinical Trial for Imported Therapeutic Biological Products

Part 2. Prophylactic Biological Products

Chapter 6. Classification of Prophylactic Biological Product Registration

Chapter 7. Material Items for Application of Prophylactic Biological Product Registration

  • 7.1. Summary Materials
  • 7.2. Summary and Evaluation of Research Results
  • 7.3. Research Materials of Bacterial (Toxic) Strains for Production Use
  • 7.4. Research Materials of Cell Matrix for Production Use
  • 7.5. Research Materials of Production Technique
  • 7.6. Experimental Materials for Quality Study, and Research Materials of Pre-clinical Efficacy and Safety
  • 7.7. Regulation Draft of Production and Assay, Drafting Explanation of Regulation, Relevant Literature
  • 7.8. Records of Production and Assay for Samples to apply for Clinical Trial
  • 7.9. Research Materials of Initial Stability Study
  • 7.10. The Quality Certificate of Animal used for Production, Research and Test
  • 7.11. Plan and Scheme for Clinical Trial
  • 7.12. Summary of Pre-clinical Investigation
  • 7.13. Summary of Relevant Literature for Clinical Trial
  • 7.14. Clinical Trial Reports, Draft of Informed Consent Form, Approval Letter of Ethics Committee
  • 7.15. Working Summary of Improving Production Technique and Quality Standard, Experimental Materials of Pharmacological and Toxicological Studies during Clinical Trials
  • 7.16. Research Materials for Determining Preservation Condition and Effective Life of Vaccines
  • 7.17. Modified Contents and Basis for Reviewed Regulation of Production and Assay
  • 7.18. Records of Production and Assay for 3 Successive Batches of Trial Products

Chapter 8. Requirements of Material Items for Application of Prophylactic Biological Product Registration

  • 8.1. The Form of Material Items
  • 8.2. The Explanatory Notes of Material Items

Chapter 9. Requirements of Clinical Trial for Application of Prophylactic Biological Product Registration

  • 9.1. General Requirements of Clinical Trial
  • 9.2. Special Requirements of Clinical Trial for Imported Prophylactic Biological Products

Part 3. Biological Products for Gene Therapy and Somatic Cell Therapy

Chapter 10. Guideline for Application of Biological Products for Gene Therapy

  • 10.1. Summary Materials
  • 10.2. Research Contents for Project and Quality Control for Product
  • 10.3. Clinical Investigations for Research Project and Product

Chapter 11. Guideline for Application of Biological Products for Somatic Cell Therapy

  • 11.1. Summary Materials
  • 11.2. Quality Control for Product
  • 11.3. Clinical Investigations

Part 4. Biological Products for Allergic Therapy

Chapter 12. Guideline for Application of Biological Products for Allergic Therapy

  • 12.1. Quality Control for Products
  • 12.2. Requirements for Pre-clinical Investigation
  • 12.3. Requirements for Clinical Trial

Chapter 13. Conclusion

Chapter 14. Appendices

  • 14.1. The Drug Administration Law of the People's Republic of China
  • 14.2. The Regulations for Implementation of the Drug Administration Law of the People's Republic of China
  • 14.3. The Good Clinical Practice of Pharmaceutical Products
  • 14.4. Form of Registration Application for Imported Drug
  • 14.5. References
  • 14.6. Company's Description
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