2012 Aarkstore.com || China Pharmaceutical Guidebook: Latest Chinese Regulations

1. Aarkstore.com announces, The Latest market research report is available in its
vast collection:
China Pharmaceutical Guidebook: Latest Chinese Regulations
for Imported Drug Registration(4th Edition)
You can also request for sample page of above mention reports on
sample@aarkstore.com
China possesses a fourth population in the world and has one of the largest drug
markets round the world. By 2011, sales on the Chinese drug market have reached
RMB 1550 billion (about US$246 billion), an increase of 7.08 fold over 2000 level. 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 25 percent per annum in
next five years. China is expected to become the fifth largest drug market in the
world by 2015.
The aim of this guidebook is to guide overseas pharmaceutical manufacturers and
producers to achieve a successful application and approval for their imported drug
registration. This guidebook is composed of four main parts as the following.
Latest Chinese Regulations for Imported Drug Registration:A
Comprehensive Guidebook for Foreign Pharmaceutical CompaniesChina
Pharmaceutical Guidebook Series (1) (4th edition)
Material and Clinical Trial Requirements of Application and Approval for
Imported Drug Registration:A Guidebook of Registration Application for
Imported Chemical Drugs China Pharmaceutical Guidebook Series (2) (4th
edition)
Material and Clinical Trial Requirements of Application and Approval for

2. Imported Drug Registration:A Guidebook of Registration Application for
Imported Traditional Chinese Medicines and Natural Medicines China
Pharmaceutical Guidebook Series (3) (4th edition)
Material and Clinical Trial Requirements of Application and Approval for
Imported Drug Registration:A Guidebook of Registration Application for
Imported Biological Products China Pharmaceutical Guidebook Series (4)
(4th edition)
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……..
Table of contents:
PART I. A COMPREHENSIVE GUIDAENCE OF IMPORTED DRUG REGISTRATION 11
CHAPTER I-1. INTRODUCTION 11
CHAPTER I-2. THE STATE FOOD AND DRUG ADMINISTRATION IN CHINA 12
2.1. SFDA’S MAIN RESPONSIBILITIES 14
2.2. SFDA’S ORGANIZATION STRUCTURE 14
CHAPTER I-3. GENERAL REGULATIONS ON APPLICATION AND APPROVAL FOR
IMPORTED DRUG REGISTRATION 19
3.1. CLASSIFICATION OF DRUGS 19
3.2. DEFINITIONS 20
3.3. GENERAL REGULATIONS ON APPLICATION AND APPROVAL FOR IMPORTED
DRUG REGISTRATION 23
3.3.1. APPLICATION AND APPROVAL FOR IMPORTED DRUGS 23
3.3.2. APPLICATION AND APPROVAL FOR REPACKAGING OF IMPORTED DRUG 28
3.3.3. SUPPLEMENTARY APPLICATION 30
3.3.4. RE-REGISTRATION 31
3.3.5.CLINICAL INVESTIGATION 33
3.3.5.1.PRECLINICAL INVESTIGATION 33
3.3.5.2.CLINICAL TRIALS 34
3.3.6. TIME LIMITS IN DRUG REGISTRATION 40
CHAPTER I-4. APPLICATION AND APPROVAL PROCEDURES FOR IMPORTED DRUG
REGISTRATION 43
4.1. APPLICATION AND APPROVAL PROCEDURE FOR IMPORTED DRUGS 44

3. 4.2.SUPPLEMENTARY APPLICATION AND APPROVAL PROCEDURE FOR IMPORTED
DRUGS…..46
4.3.APPLICATION AND APPROVAL PROCEDURE FOR CLINICAL TRIALS.48
List of Figures
List of Tables are also include.
For more Reports Plz follow The link:
Material and Clinical Trial Requirements of Application and Approval for Imported
Drug Registration: A Guidebook of Registration Application.... China Pharmaceutical
Guidebook Series (3)(4th edition)
Material and Clinical Trial Requirements of Application and Approval for Imported
Drug Registration: A Guidebook of Registration Application for Imported Biological
Products China Pharmaceutical Guidebook Series (4) (4th edition)
Invest in China: A Guidebook for Application and Approval of Establishment
Registration for Foreign Investment Enterprises(The Invest in China Guidebook
Series (1)
China Pharmaceutical Guidebook: Latest Chinese Regulations for Imported Drug
Registration(4th Edition)
Chinas Guidebook for Pharmaceutical Patent Protection
Search More Reports Related to This Category :
China Pharmaceutical
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