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市場調查報告書
中國外商製藥公司綜合指南(1)：第4版
A Comprehensive Guidebook for Foreign Pharmaceutical Companies China Pharmaceutical Guidebook Series (1) (4th edition)
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中國外商製藥公司綜合指南(1)：第4版 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152 Pages 價格從美金750起跳。
中國因其醫療藥物當局以過度管理及法規，管理其進口藥劑註冊申請及核准，使其流程變得極為複雜。此外，管理法規也經常變更，缺乏透明度，使得理解進口藥劑註冊相關最新法規，成為外商製藥公司成功於中國受到核准之重要先決條件。
本報告為，中國醫療藥物指南系列之一，介紹註冊進口藥劑之最新法規，外商製藥公司於藥劑申請註冊時之指南，以下列摘要形式闡述。
第1章 簡介
第2章 中國國家食品藥品監督管理局（SFDA）
第3章 進口藥劑註冊申請之一般規定
- 藥劑分類
- 定義
- 進口藥劑註冊申請許可相關之規定
- 進口藥劑註冊申請及核准
- 進口藥劑重新包裝相關之申請及核准
- 補充應用
- 重新註冊
- 臨床實驗
- 藥劑註冊之時間限制
第4章 進口藥劑註冊之申請核准手續
- 進口藥劑之申請核准手續
- 進口藥劑之補充申請核准手續
- 臨床實驗之申請核准手續
第5章 結論
第6章 附錄
- 中國之藥品管理法
- 中國之藥品管理法實施規定
- 醫療藥品之GCP
- 醫療藥品之GMP
- 進口藥劑之註冊申請文件
- 參考資訊
- 資訊來源
- 作者簡介
- 企業簡介
Abstract
Executive Summary
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 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. This is the first guidebook of the China Pharmaceutical Guidebook
Series. It will provide a detailed introduction of the latest Chinese
regulations for imported drug registration, and guide overseas pharmaceutical
manufacturers and producers to file the application for their drugs with the
Chinese pharmaceutical authorities.
Chapter 2 provides an overview of the main responsibilities and organization
structure of the State Food and Drug Administration (hereinafter called SFDA)
that is current Chinese pharmaceutical authority at the central level, and
takes responsible for application and approval for imported drug registration.
The aim of this chapter is to give direction of gateway for application of
imported drug registration. Chapter 3 addresses the comprehensive regulations
for imported drug registration in China, from the classification of drugs,
definitions relating to application for imported drug registration, the
application and approval for imported drugs and repackaging of imported drugs,
the supplementary application and re-registration for imported drugs, the
clinical investigation for application of imported drug registration to the
time limits in drug registration. Chapter 4 introduces the procedures of
application and approval for imported drug registration, including the
procedures of the initial application and approval for imported drugs, the
supplementary application and approval for imported drugs, and the application
and approval for clinical trials relating to imported drugs. The guidebook
concludes in chapter 5 by highlighting the significant suggestions for
overseas pharmaceutical manufacturers and producers looking to achieve a
successful application of their drug registration in China. The appendices in
chapter 6 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 for application and
approval of imported drug registration. For the detailed requirements of
material items and clinical trial for application and approval of imported
drug registration of various categories, such as chemical drugs, biological
products, traditional Chinese medicines and natural medicines, audience can
learn from various fascicles of the China Pharmaceutical Guidebook Series.
Report Highlights
- An overview of the main responsibilities and organization structure of the
SFDA (The State Food and Drug Administration) that is current Chinese
pharmaceutical authority at the central level, and takes responsible for
application and approval for imported drug registration.
- The comprehensive regulations for imported drug registration in China,
from the classification of drugs, definitions relating to application for
imported drug registration, the application and approval for imported drugs
and repackaging of imported drugs, the supplementary application and
re-registration for imported drugs, the clinical investigation for application
of imported drug registration to the time limits in drug registration.
- The procedures of application and approval for imported drug registration,
including the procedures of the initial application and approval for imported
drugs, the supplementary application and approval for imported drugs, and the
application and approval for clinical trials relating to imported drugs.
- The significant suggestions for overseas pharmaceutical manufacturers and
producers looking to achieve a successful application for their
pharmaceuticals 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
Chapter 2. The State Food and Drug Administration in China
- 2.1. SFDA' s Main Responsibilities
- 2.2. SFDA' s Organization Structure
Chapter 3. General Regulations on Application and Approval for Imported Drug Registration
- 3.1. Classification of Drugs
- 3.2. Definitions
- 3.3. General Regulations on Application and Approval for Imported Drug
Registration
- 3.3.1. Application and Approval for Imported Drugs
- 3.3.2. Application and Approval for Repackaging of Imported Drug
- 3.3.3. Supplementary Application
- 3.3.4. Re-registration
- 3.3.5.Clinical Investigation
- 3.3.5.1.Preclinical investigation
- 3.3.5.2. Clinical Trials
- 3.3.6. Time Limits in Drug Registration
Chapter 4. Application and Approval Procedures for Imported Drug Registration
- 4.1. Application and Approval Procedure for Imported Drugs
- 4.2. Supplementary Application and Approval Procedure for Imported Drugs
- 4.3. Application and Approval Procedure for Clinical Trials
Chapter 5. Conclusion
Chapter 6. Appendices
- 6.1. The Drug Administration Law of the People' s Republic of China
- 6.2. The Regulations for Implementation of the Drug Administration Law of
the People' s Republic of China
- 6.3. The Good Clinical Practice of Pharmaceutical Products
- 6.4. The Good Manufacturing Practice for Pharmaceutical Products
- 6.5. Form of Registration Application for Imported Drug
- 6.6. References
- 6.7. Resources
- 6.8. Author' s Biography
- 6.9. Company' s Description
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