China Pharmaceutical Regulation (3)

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Preface

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.

China Pharmaceutical Guidebook Series (3) (3rd Edition)

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

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

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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Access China Report the drug registration implemented by the Chinese pharmaceutical authorities on December 1,

Natural Medicines

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

In this guidebook series, overseas pharmaceutical manufacturers and producers can easily find

promulgated the latest “Measures for the Administration of Drug Registration” on July 10 2007,

out every answer that they will meet question during process of application and approval for

and the latest “Measures” will enter into force since October 1, 2007. These “Measures” provide

their imported drug registration. Since the publication of China Pharmaceutical Guidebook

the latest detailed requirements and procedures of application and approval for imported drug

Series, many executives from overseas pharmaceutical companies have paid attention to this

registration. Under such circumstance, Access China Management Consulting Ltd published the

guidebook series, and expect to acquire latest detailed information about Chinese regulations

China Pharmaceutical Guidebook Series. The aim of this guidebook series is to guide overseas

for imported drug registration, so that Access China Management Consulting Ltd completed the

pharmaceutical manufacturers and producers to achieve a successful application and approval

third edition to contribute this latest China Pharmaceutical Guidebook Series to overseas

for their imported drug registration. This guidebook series are composed of four guidebooks as

pharmaceutical companies. In this latest China Pharmaceutical Guidebook Series, many useful

the following.

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

 Latest Chinese Regulations for Imported Drug Registration:

Chinese Good Manufacturing Practice for Pharmaceutical Products, the Form of Registration

A Comprehensive Guidebook for Foreign Pharmaceutical Companies

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

 Material and Clinical Trial Requirements of Application and Approval for Imported Drug

and law, can help guide overseas pharmaceutical manufacturers and producers to achieve a

Registration:

successful application and approval for their imported drug registration in China.

A Guidebook of Registration Application for Imported Chemical Drugs

 Material and Clinical Trial Requirements of Application and Approval for Imported Drug

Report Highlights

Registration: A Guidebook of Registration Application for Imported Biological Products



An overview of the classification of medicine registration formulated by the SFDA (State Food and Drug Administration in China).

 Material and Clinical Trial Requirements of Application and Approval for Imported Drug



The material items for application of medicine Registration.



The requirements of material items for application of medicine registration.

Registration: A Guidebook of Registration Application for Imported Traditional Chinese Medicines and Copy right © Access China Management Consulting Ltd.

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The requirements of clinical trial for application of medicine registration.



The significant suggestions for overseas pharmaceutical manufacturers and producers

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

looking to achieve a successful application for their traditional Chinese medicine and natural

medicine. The Chinese pharmaceutical authorities collect the traditional Chinese medicines and

medicine registration in China. 

the natural medicines into a category for registration application. Therefore, this guidebook will

Many useful resources of law and regulations, including the Drug Administration Law of the

provide not only the introduction for registration application of imported traditional Chinese

People’s Republic of China, the Regulations for Implementation of the Drug Administration

medicines but for the natural medicines.

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.

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

Who should buy this report?

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

Companies wishing to enter a lucrative drug market in China.

applicant to not only submit designated material items in accordance with prescribed category of •

•

Companies interested in understanding the latest Chinese regulations on application and

traditional Chinese medicines and natural medicines to apply for registration, but also conduct

approval for imported drug registration.

the clinical trials for certain categorical traditional Chinese medicines and natural medicines.

Senior executive officers engaging regulatory and registration affairs for drugs. 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,

Executive Summary

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

The traditional medicines in Orient, especially, the traditional Chinese medicines are always

medicine and natural medicine registration. The SFDA collected all materials for application of

regarded by occidental as mysterious medicines. Until today not only the chemical composition

traditional Chinese medicine and natural medicine registration into four categories and 33 items,

of traditional Chinese medicines almost can not been expressed by a precise chemical

i.e. the comprehensive materials, the research materials of pharmaceutics, the research

structural formula, but also the indications of the majority of traditional Chinese medicines still

materials of pharmacology and toxicology, and the materials of clinical investigation. For

can not been clearly described by the modern medical terminologies. How the Chinese drug

administrative requirement of traditional Chinese medicine and natural medicine registration, the

authorities to administer the registration application for such mysterious traditional Chinese

SFDA provides the detailed explanations for many material items and precedes the ordinal

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Access China Report 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

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Chinese medicine and natural medicine registration. Chapter 4 introduces the requirements of material items for application of traditional Chinese medicine and natural medicine registration in

Title: Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration for Imported Traditional Chinese TableApplication of Contents Medicines and Natural Medicines

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 traditional Chinese medicine and natural medicine registration stipulated by the SFDA. The explanatory notes

China Pharmaceutical Guidebook Series (3) (3rd edition)

further explain the requirements of material items for various categorical traditional Chinese

Preface................................................................................................................................................1 Published Date: October 2007 Table of Contents........................................................................................................................ .......4

medicines and natural medicines. To understand the contents of this section is a core for application of traditional Chinese medicine and natural medicine registration. The application of

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imported traditional Chinese medicine and natural medicine 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 traditional Chinese medicine and natural medicine registration. There are two parts, i.e. the general requirements of clinical trial and the special requirements of clinical trial for imported traditional Chinese medicines and natural medicines. The guidebook concludes in chapter 6 by highlighting the significant suggestions for overseas pharmaceutical manufacturers and producers looking to

Delivery Details

achieve a successful application for their traditional Chinese medicine and natural medicine registration in China. Last, the appendices in chapter 7 include the Drug Administration Law of

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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

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Good Manufacturing Practice for Pharmaceutical Products, the Form of Registration Application

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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

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materials and the clinical trials for application of imported traditional Chinese medicine and

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natural medicine registration. For the detailed pathway and procedure for application and

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approval of imported drug registration, audience can learn from the first guidebook of the China Pharmaceutical Guidebook Series ---- Latest Chinese Regulations for Imported Drug

Please send an E-mail and attached this form by [email protected] to 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 Report 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, RUL: http://www.accesschinainfo.com 402 Suite, No. 70 Building , MuFu ShanZhuang He Yan Road, Nanjing 210038, People’s Republic of China Tel : +86-25-83422936 Fax: +86-25-85337409 Email: [email protected] [email protected] Copy right © Access China Management Consulting Ltd. All rights reserved. No part of this publication may be reproduced, abstracted, stored in any retrieval system or transmitted in any form or be any means without written permission of the copyright owner/publisher. Access China Management Consulting Ltd is a professional provider of managements and consulting services specifically designed to provide overseas clients a virtual Copy right © Access China Management Consulting Ltd.

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