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Offline Labwu Zengxian

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Latest Chinese Regulations on Drug Application
« on: 23/04/2006 07:27:59 »


Access China will publish the China Pharmaceutical Guidebook Series .
In May,we will first publish two reports of this series.

This guidebook series provide a guide for overseas pharmaceutical manufacturers and producers to achieve a successful application and approval for their imported drug registration.The overseas pharmaceutical manufacturers and producers looking to enter the Chinese market can find from the executive summaries that this guidebook series are very significant for their products to file the application with the Chinese drug authorities.
Here I send the publication dates,  format,  along with tables
of contents and executive summaries for two reports of China
Pharmaceutical Guidebook Series as the following. The other two
reports will be published in July.
I look forward to comments from you and discussing on this topic.
Best wishes,

Yours sincerely,

Labwu Zengxian
President
Access China
newbielink:http://www.accesschinainfo.com [nonactive]
zengxian.wu@gmail.com
=====================================================
China Pharmaceutical Guidebook Series
Preface
China possesses a fourth population in the world and has one of the
largest drug markets round the world. By 2003, sales on the Chinese
drug market have reached $6.1 billion dollars, an increase of 2.3 fold
over 1998 levels. 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 of 20-25 percent per annum in
next five years. China is expected to become the fifth largest drug
market in the world by 2010.

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 2003, sales of imported drugs have shared one fifth 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 to 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.
The latest "Measures for the Administration of Drug Registration" have
entered into force since May 1, 2005. These "Measures" provide
detailed requirements and procedures of application and approval for
imported drug registration. Under such circumstance, Access China
Management Consulting Ltd writes out the China Pharmaceutical
Guidebook Series. 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
following.

É‹ Chinese Latest Regulations for Imported Drug Registration:
A Comprehensive Guidebook for Foreign Pharmaceutical Companies

É‹ Material and Clinical Trial Requirements of Application and Approval
for Imported Drug Registration:
A Guidebook of Registration Application for Imported Chemical Drugs

É‹ Material and Clinical Trial Requirements of Application and Approval
for Imported Drug Registration:
A Guidebook of Registration Application for Imported Biological Products
É‹ Material and Clinical Trial Requirements of Application and Approval
for Imported Drug Registration:
A Guidebook of Registration Application for Imported Traditional
Chinese Medicines and Natural Medicines


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.

China Pharmaceutical Guidebook Series
                         (1)
Chinese Latest Regulations for Imported Drug Registration:
A Comprehensive Guidebook for Foreign Pharmaceutical Companies

Published Date: May 2006
Page Count: 40
Format: electronic

Exceutive 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 Chinese latest 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 Chinese latest 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 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. After have skimmed through this chapter, audience can be
clearly aware of the Chinese latest regulations for imported 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 references,
a useful resources of URL, author's biography, and description of
Access China Management Consulting Ltd.

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 Drug
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. References
6.2. Resources
6.3. Author's Biography
6.4. Company's Description


China Pharmaceutical Guidebook Series
                                 (2)
Material and Clinical Trial Requirements of Application and Approval
for Imported Drug Registration:
A Guidebook of Registration Application for Imported Chemical Drugs
[/red]
Published Date: May 2006
Page Count: 31
Format: electronic

Exceutive Summary
In China, like in other Western countries, the pharmaceutical
authority ----- the SFDA requests applicant to submit complicate and
reliable materials for application of drug registration. The SFDA
stipulated the classification of drug registration in order to
administer the application of drug registration. At the same time, the
SFDA collected the materials for application of drug registration into four categories and 32 items in accordance with various drug
categories. When an application of drug registration is filed, the
SFDA will request applicant to not only submit designated material
items in accordance with prescribed category of drug to apply for
registration, but also conduct the clinical trials for certain drug
categories.

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.

Chapter 2 provides an overview of the classification of drug
registration that is formulated by the SFDA. To understand this
classification of drug registration only is the first step for an
application of drug registration, because applicant must file the
application in accordance with this classification of drug
registration. Chapter 3 addresses the material items for application
of drug registration. The SFDA collected all materials for application
of drug registration into four categories and 32 items. That are
comprehensive materials, research materials of pharmacy, research
materials of pharmacology and toxicology, and materials of clinical
investigation. For administrative requirement of drug registration,
the SFDA provides the detailed explanations for many material items
and precedes the ordinal numeral for each material item. When an
application is filed, the SFDA will request applicant to submit the
materials for application of drug registration of various categories
in accordance with the material item's ordinal numeral. Therefore, to
understand the material items is the second step for application of
drug registration. Chapter 4 introduces the requirements of material
items for application of drug registration 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 application
of drug registration stipulated by the SFDA. The explanatory notes
further explain the requirements of material items for various drug
categories. To understand the contents of this section is a core for
application of drug registration. The application of imported chemical
drug registration must accord with the material items prescribed by
the form of material Items and the explanatory notes to submit
materials. Chapter 5 addresses the requirements of clinical trial for
application of drug registration. There are two parts, that is the
general requirements of clinical trial and the special requirements of
clinical trial for imported chemical drug. Chapter 6 introduces the
material and clinical trial requirements for application of
radioactive pharmaceuticals, from the definitions, the requirements of material items, explanatory notes of material items to the
requirements of clinical trial. The guidebook concludes in chapter 7
by highlighting the significant suggestions for overseas
pharmaceutical manufacturers and producers looking to achieve a
successful application for their chemical drug registration in China.
Last, the appendices in chapter 8 include 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 Chinese latest regulations for
imported chemical drug registration.


Table of Contents

Preface
Chapter 1. Introduction
Chapter 2. Classification of Drug Registration
Chapter 3. Material Items for Application of Drug Registration
3.1. Comprehensive Materials
3.2. Research Materials of Pharmacy
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 Chemical Drugs
Chapter 6. Material and Clinical Trial Requirements for Application of
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. References
8.2 . Resources
8.3. Author's Biography
8.4. Company's Description
=========================================================


 

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