中國進口藥劑註冊申請、批准所需文件及臨床實驗要求項目：進口生物製劑之註冊申請指南 是由出版商Access China Management Consulting在2011年05月所出版的。
這份英文市場調查報告書包含182 Pages 價格從美金750起跳。
中國於生物醫療藥物之開發遠遠落後已開發國家之腳步。因此，中國醫療藥物當局所規定之生物醫療藥物註冊申請文件及臨床實驗要求項目仍未有其體制。中國醫療藥物主管機關SFDA（國家食品藥品監督管理局）將生物醫療藥物註冊申請分為治療用產品及預防產品兩類。但SFDA於治療用產品中並無明確規定基因治療、體細胞治療、過敏治療需要的生物製劑註冊申請文件，以及統一之臨床實驗要求項目，而是各別設有其指南。本指南將統整其多元化、複雜化，乃至於一般之原則。
本報告為，中國醫療藥物指南系列之一，詳細探討SFDA之進口生物製劑註冊申請文件及臨床實驗要求項目，並匯整其概要及領域別要求，以下列摘要形式闡述。
第1章 簡介
第2章 治療用生物製劑註冊之分類
第3章 治療用生物製劑註冊申請之文件項目
- 綜合文件
- 藥劑學研究資料
- 藥理學、毒理學研究資料
- 臨床實驗文件
- 其他
第4章 治療用生物製劑註冊申請文件之要求項目
第5章 治療用生物製劑註冊申請之臨床實驗要求項目
- 一般之臨床實驗要求項目
- 進口治療用生物製劑之臨床實驗相關特殊要求
第6章 預防用生物製劑之分類
第7章 生物製劑之註冊申請文件項目
- 綜合文件
- 研究結果大綱及評估
- 製造用細菌（毒性）種子之研究資料
- 細胞間質之研究資料
- 生產技術之研究資料
- 品質調查之實驗資料
- 資產、分析規定草案、註冊、相關文獻注釋
- 製造紀錄及樣本分析
- 初期安定化之研究資料，其他
第8章 預防用生物製劑註冊申請所需文件之要求項目
第9章 預防用生物製劑註冊申請所需之臨床實驗要求項目
- 一般之臨床實驗要求項目
- 進口預防用生物製劑之臨床實驗相關特殊要求
第10章 基因治療所需之生物製劑申請指南
- 綜合文件
- 計畫研究內容及產品之品質管理
- 研究計畫及產品臨床實驗
第11章 體細胞治療所需之生物製劑申請指南
第12章 過敏治療所需之生物製劑申請指南
- 產品之品質管理
- 前臨床實驗相關要求項目
- 臨床實驗相關要求項目
第13章 結論
第14章 附錄
Abstract
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. Just for
this reason, the requirements of materials and clinical trials for
registration application of biopharmaceuticals stipulated by the Chinese
pharmaceutical authority are far from systematic and uniform.
In China, the pharmaceutical 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 common principle for them because of their diversity
and complexity.
This is the fourth guidebook of the China Pharmaceutical Guidebook Series. It
will provide 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 SFDA stipulated not only the classification of product registration but
also the requirements of material items and clinical trials for various
categorical biopharmaceuticals in order to administer the registration
application of theirs. For every categorical biopharmaceuticals, to understand
the classification of product registration only is the first step for a
registration application of biological products, because applicant must file
the application in accordance with the classification of biological product
registration. The SFDA collected all materials submission for registration
application of biological products into various items and preceded the ordinal
numeral for every material item, moreover, every item includes many sub-items.
When an application is filed, the SFDA will request applicant to submit the
materials for registration application of biological products of various
categories in accordance with the material item' s ordinal numeral. Therefore,
to understand the material items is the second step for registration
application of biological products. The requirements of material items for
registration application of biological products are introduced in terms of the
form of material items and their explanatory notes. The form of material items
represents the current requirements of material items for registration
application of biological products stipulated by the SFDA. The explanatory
notes further explain the requirements of material items for various
categorical biological products. To understand the requirements for material
items is a core for registration application of biological products. The
application of imported biological products must accord with the material
items prescribed by the form of material items and the explanatory notes to
submit materials. In general, the requirements of clinical trial for
registration application of biological products are two parts, i.e. the
general requirements of clinical trial and the special requirements of
clinical trial for imported biological products. The application of imported
biological products must accord with not only the general requirements of
clinical trial but also the special requirements of clinical trial for
imported biological products. The application of biological products for the
gene therapy, the somatic cell therapy and the allergic therapy must follow up
the provisions introduced in the Chapter 10, 11, and 12 respectively.
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 Drug Administration
Law of the People' s Republic of China, the Chinese Good Clinical Practice of
Pharmaceutical Products, the Chinese Good Manufacturing Practice for
Pharmaceutical Products, the Form of Registration Application for Imported
Drug, references, a useful resources of URL, author' s biography, 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 ---- 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
Chinese Good Manufacturing Practice for 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
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. Comprehensive 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. Comprehensive Materials
- 7.2. Summary and Evaluation of Research Results
- 7.3. Research Materials of Bacterial (Toxic) Seeds 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
- 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
- 7.11. 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. Comprehensive 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. Comprehensive 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. The Good Manufacturing Practice for Pharmaceutical Products
- 14.5. Form of Registration Application for Imported Drug
- 14.6. References
- 14.7. Resources
- 14.8. Author' s Biography
- 14.9. Company' s Description
