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Preface

China Pharmaceutical Guidebook Series
(3)
(3rd Edition)
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
China possesses a fourth population in the world and has one of the largest drug markets round
the world. By 2006, sales on the Chinese drug market have reached $12 billion dollars, an
increase of 3.8 fold over 1998 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 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
2006, 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. 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

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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 latest “Measures for the Administration of Drug Registration” on July 10 2007,
and the latest “Measures” will enter into force since October 1, 2007. These “Measures” provide
the latest detailed requirements and procedures of application and approval for imported drug
registration. Under such circumstance, Access China Management Consulting Ltd published 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
the following.
 Latest Chinese Regulations for Imported Drug Registration:
A Comprehensive Guidebook for Foreign Pharmaceutical Companies
 Material and Clinical Trial Requirements of Application and Approval for Imported Drug
Registration:
A Guidebook of Registration Application for Imported Chemical Drugs
 Material and Clinical Trial Requirements of Application and Approval for Imported Drug
Registration:
A Guidebook of Registration Application for Imported Biological Products
 Material and Clinical Trial Requirements of Application and Approval for Imported Drug
Registration:
A Guidebook of Registration Application for Imported Traditional Chinese Medicines and
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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. Since the publication of China Pharmaceutical Guidebook
Series, many executives from overseas pharmaceutical companies have paid attention to this
guidebook series, and expect to acquire latest detailed information about Chinese regulations
for imported drug registration, so that Access China Management Consulting Ltd completed the
third edition to contribute this latest China Pharmaceutical Guidebook Series to overseas
pharmaceutical companies. In this latest China Pharmaceutical Guidebook Series, 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 are newly added. After have skimmed through these
guidebooks, audience can clearly acquire a comprehensive and thorough knowledge of the
latest Chinese regulations for 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.
Report Highlights
 An overview of the classification of medicine registration formulated by the SFDA (State
Food and Drug Administration in China).
 The material items for application of medicine Registration.
 The requirements of material items for application of medicine registration.
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 The requirements of clinical trial for application of medicine registration.
 The significant suggestions for overseas pharmaceutical manufacturers and producers
looking to achieve a successful application for their traditional Chinese medicine and natural
medicine 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.
Executive Summary
The traditional medicines in Orient, especially, the traditional Chinese medicines are always
regarded by occidental as mysterious medicines. Until today not only the chemical composition
of traditional Chinese medicines almost can not been expressed by a precise chemical
structural formula, but also the indications of the majority of traditional Chinese medicines still
can not been clearly described by the modern medical terminologies. How the Chinese drug
authorities to administer the registration application for such mysterious traditional Chinese
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medicines? This is the third guidebook of the China Pharmaceutical Guidebook Series. It will
provide a detailed introduction of the Chinese pharmaceutical authorities’ requirements for
materials and clinical trials of application and approval for imported traditional Chinese
medicine. The Chinese pharmaceutical authorities collect the traditional Chinese medicines and
the natural medicines into a category for registration application. Therefore, this guidebook will
provide not only the introduction for registration application of imported traditional Chinese
medicines but for the natural medicines.
In China, like in other Western countries, the pharmaceutical authority ----- China State
Food and Drug Administration (hereafter called SFDA) requests applicant to submit complicate
and reliable materials for application of medicine registration. The SFDA stipulated the
classification of medicine registration in order to administer the application of traditional Chinese
medicine and natural medicine registration. At the same time, the SFDA collected the materials
for application of traditional Chinese medicine and natural medicine registration into four
categories and 33 items in accordance with various medicine categories. When an application of
traditional Chinese medicine and natural medicine registration is filed, the SFDA will request
applicant to not only submit designated material items in accordance with prescribed category of
traditional Chinese medicines and natural medicines to apply for registration, but also conduct
the clinical trials for certain categorical traditional Chinese medicines and natural medicines.
Chapter 2 provides an overview of the classification of medicine registration that is
formulated by the SFDA. To understand this classification of medicine registration only is the first
step for an application of traditional Chinese medicine and natural medicine registration,
because applicant must file the application in accordance with this classification of medicine
registration. Chapter 3 addresses the material items for application of traditional Chinese
medicine and natural medicine registration. The SFDA collected all materials for application of
traditional Chinese medicine and natural medicine registration into four categories and 33 items,
i.e. the comprehensive materials, the research materials of pharmaceutics, the research
materials of pharmacology and toxicology, and the materials of clinical investigation. For
administrative requirement of traditional Chinese medicine and natural medicine registration, the
SFDA provides the detailed explanations for many material items and precedes the ordinal
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numeral for each material item. When an application is filed, the SFDA will request applicant to
submit the materials for application of traditional Chinese medicine and natural medicine
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 traditional
Chinese medicine and natural medicine registration. Chapter 4 introduces the requirements of Access China Order Form
material items for application of traditional Chinese medicine and natural medicine registration in
Title: Material and Clinical Trial Requirements of Application and Approval for
terms of the form of material items and their explanatory notes. The form of material items Imported Drug Registration:
represents the current requirements of material items for application of traditional Chinese TableApplication
A Guidebook of Registration of Contents
for Imported Traditional Chinese
Medicines and Natural Medicines
medicine and natural medicine registration stipulated by the SFDA. The explanatory notes
further explain the requirements of material items for various categorical traditional Chinese China Pharmaceutical Guidebook Series (3) (3rd edition)
Preface................................................................................................................................................1
medicines and natural medicines. To understand the contents of this section is a core for
Published
Table Date: October 2007
of Contents........................................................................................................................ .......4
application of traditional Chinese medicine and natural medicine registration. The application of Page Count: 139
imported traditional Chinese medicine and natural medicine registration must accord with the Unit Price: US$ 750
Site License: US$3500
material items prescribed by the form of material Items and the explanatory notes to submit Format: Electronic PDF copy
materials. Chapter 5 addresses the requirements of clinical trial for application of traditional Please send me ___________Copy/ies
Payment: Pay by bank wire transfer to:
Chinese medicine and natural medicine registration. There are two parts, i.e. the general Account Number: 4447803-007000-900079468
requirements of clinical trial and the special requirements of clinical trial for imported traditional Swift Code: BKCHCNBJ 940
Bank Name: BANK OF CHINA, NANJING SAJIAWAN SUB-BRANCH
Chinese medicines and natural medicines. The guidebook concludes in chapter 6 by highlighting
Bank Address: 212 ZhongShan Beilu Road, Nanjing , People’s Republic of China
the significant suggestions for overseas pharmaceutical manufacturers and producers looking to
achieve a successful application for their traditional Chinese medicine and natural medicine Delivery Details
registration in China. Last, the appendices in chapter 7 include the Drug Administration Law of
Title: ______________________ Full name: ____________________________
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 Job title: ___________________ Organization: ___________________________
Good Manufacturing Practice for Pharmaceutical Products, the Form of Registration Application Email Address: ____________________________________________________
for Imported Drug, references, a useful resources of URL, author’s biography, and description of
Postal Address: ____________________________________________________
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 Postal/Zip code: _________________ Country: __________________________
materials and the clinical trials for application of imported traditional Chinese medicine and
Phone number: ___________________ Fax number: ______________________
natural medicine registration. For the detailed pathway and procedure for application and
approval of imported drug registration, audience can learn from the first guidebook of the China Signed: _________________________ Date: ____________________________
Pharmaceutical Guidebook Series ---- Latest Chinese Regulations for Imported Drug
Please send an E-mail and attached this form by zengxian.wu@gmail.com to
Registration: A Comprehensive Guidebook for Foreign Pharmaceutical Companies. us. As soon as we receive your payment, we'll send the report to you in four
business days.
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Access China Management Consulting Ltd is a professional provider of
managements and consulting services specifically designed to provide overseas clients a virtual
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gateway to enter the lucrative market of China. Access China is headquartered in Nanjing,
Jiangsu Province, Eastern China.
At present, company provides consulting services for foreign clients as follows.
 Research of Chinese pharmaceutical industry and market;
 license transfer; registration of imported drugs and new drugs; pharmaceutical patent
applications; management of laws and regulations on pharmaceuticals;
 Consultancy on the Chinese laws, administrative regulations on pharmaceutical
administration;
 Provide analyses of feasibility for mergers and acquisitions of the existing Chinese
pharmaceutical enterprises;
 Act as agent, within a range of authorized, implement operation to purchase and merge the
existing Chinese pharmaceutical enterprises in accordance with the order of foreign
investors;
 Help foreign investors make the registration of Foreign Investment Enterprises, including
Sino-foreign equity joint ventures (EJV), Sino-foreign cooperative joint ventures (CJV),wholly
foreign-owned enterprises (WFOE), Representative Office;
 Provide a range of customized and standardized solutions including industry report,
research report of strategic investment, market analyses, and other subscription-based
research and information on the latest development and strategies used in a variety of
sectors.
Access China Management Consulting pursues the principle of "integrating resources and
creating value" to contribute to foreign clients.
Access China Management Consulting Ltd,
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He Yan Road, Nanjing 210038,
People’s Republic of China
Tel : +86-25-83422936
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