China Pharmaceutical Regulation (4)

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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 (4) (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 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

Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Biological Products

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

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



The classification of biological product registration



The material items for application of biological product registration



The requirements of material items for application of biological product registration



The requirements of clinical trial for application of biological product registration



The guideline for application of biological products for human gene therapy



The guideline for application of biological products for somatic cell therapy

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 Copy right © Access China Management Consulting Ltd.

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The guideline for application of biological products for allergic therapy



The significant suggestions for overseas pharmaceutical manufacturers and producers

China) divided the biopharmaceuticals for registration application into two classifications, i.e. the therapeutic biological products and the prophylactic biological products. However, in the classification of therapeutic biological products, the SFDA does not provide the uniform

looking to achieve a successful application for their biopharmaceuticals registration in China. 

requirements of materials and clinical trials for application of biological products for the gene

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

therapy, the somatic cell therapy and the allergic therapy, but stipulates the other guidelines for

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

them respectively. These guidelines provide only a common principle for them because of their

Law of the People’s Republic of China, the Chinese Good Clinical Practice of

diversity and complexity.

Pharmaceutical Products, the Chinese Good Manufacturing Practice for Pharmaceutical Products, the Form of Registration Application for Imported Drug, and so on. This is the fourth guidebook of the China Pharmaceutical Guidebook Series. It will provide a detailed introduction of SFDA’s requirements for materials and clinical trials of registration application and approval for imported biological products. This guidebook will introduce SFDA’s requirements for materials and clinical trials of registration application for imported biological products in four parts and twelve chapters according to the existing a serial of regulations and

Who should buy this report?

guidelines. The Part I provides an introduction of the requirements for materials and clinical trials of registration application for imported therapeutic biological products. The Part II introduces the

•

Companies wishing to enter a lucrative drug market in China.

•

Companies interested in understanding the latest Chinese regulations on application and

biological products. The Part III addresses the requirements for materials and clinical trials of

approval for imported drug registration.

registration application for imported gene therapeutic biological products and somatic cell

•

requirements for materials and clinical trials of registration application for imported prophylactic

therapeutic biological products. The Part IV addresses the requirements for materials and

Senior executive officers engaging regulatory and registration affairs for drugs.

clinical trials of registration application for imported allergic therapeutic biological products.

The SFDA stipulated not only the classification of product registration but also the

Executive Summary

requirements of material items and clinical trials for various categorical biopharmaceuticals in

The biopharmaceutical industry is one of the burgeoning industries. In the field of

order

biopharmaceuticals, vast knowledge awaits people to explore. The biopharmaceuticals are

to

administer

the

registration

application

of

theirs.

For

every

categorical

biopharmaceuticals, to understand the classification of product registration only is the first step

diversified and complex. In China, the development of biopharmaceutical industry is far behind

for a registration application of biological products, because applicant must file the application in

the developed countries. Just for this reason, the requirements of materials and clinical trials for

accordance with the classification of biological product registration. The SFDA collected all

registration application of biopharmaceuticals stipulated by the Chinese pharmaceutical

materials submission for registration application of biological products into various items and

authority are far from systematic and uniform.

preceded the ordinal numeral for every material item, moreover, every item includes many subitems. When an application is filed, the SFDA will request applicant to submit the materials for

In China, the pharmaceutical authority ----- the SFDA (State Food and Drug Administration, Copy right © Access China Management Consulting Ltd.

registration application of biological products of various categories in accordance with the 3

Access China Report material item’s ordinal numeral. Therefore, to understand the material items is the second step

Table of Contents

for registration application of biological products. The requirements of material items for registration application of biological products are introduced in terms of the form of material items and their explanatory notes. The form of material items represents the current

Preface................................................................................................................................................1 Table of Contents...............................................................................................................................4

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requirements of material items for registration application of biological products stipulated by the SFDA. The explanatory notes further explain the requirements of material items for various

Title: Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration:

categorical biological products. To understand the requirements for material items is a core for registration application of biological products. The application of imported biological products

A Guidebook of Registration Application for Imported Biological Products

must accord with the material items prescribed by the form of material items and the explanatory

China Pharmaceutical Guidebook Series (4) (3rd edition)

notes to submit materials. In general, the requirements of clinical trial for registration application of biological products are two parts, i.e. the general requirements of clinical trial and the special

Published Date: October 2007 Page Count: 182 Unit Price: US$ 750 Site License: US$3500 Format: Electronic PDF copy Please send me ___________Copy/ies Payment: Pay by bank wire transfer to: Account Number: 4447803-007000-900079468 Swift Code: BKCHCNBJ 940 Bank Name: BANK OF CHINA, NANJING SAJIAWAN SUB-BRANCH Bank Address: 212 ZhongShan Beilu Road, Nanjing , People’s Republic of China

requirements of clinical trial for imported biological products. The application of imported biological products must accord with not only the general requirements of clinical trial but also the special requirements of clinical trial for imported biological products. The application of biological products for the gene therapy, the somatic cell therapy and the allergic therapy must follow up the provisions introduced in the Chapter 10, 11, and 12 respectively.

The guidebook concludes in chapter 13 by highlighting the significant suggestions for overseas pharmaceutical manufacturers and producers looking to achieve a successful

Delivery Details

application for their biopharmaceuticals registration in China. Last, the appendices in chapter 14 include the Drug Administration Law of the People’s Republic of China, the Regulations for the

Title: ______________________ Full name: ____________________________

Drug Administration Law of the People’s Republic of China, the Chinese Good Clinical Practice

Job title: ___________________ Organization: ___________________________

of Pharmaceutical Products, the Chinese Good Manufacturing Practice for Pharmaceutical

Email Address: ____________________________________________________

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

Postal Address: ____________________________________________________

have skimmed through this guidebook, audience can be clearly aware of the latest Chinese

Postal/Zip code: _________________ Country: __________________________

regulations on requirements of the materials and the clinical trials for registration application of

Phone number: ___________________ Fax number: ______________________

imported biological products. For the detailed pathway and procedure for application and approval of imported biological products, audience can learn from the first guidebook of the

Signed: _________________________ Date: ____________________________

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.

Registration: A Comprehensive Guidebook for Foreign Pharmaceutical Companies. Copy right © Access China Management Consulting Ltd.

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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 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 Copy right © Access China Management Consulting Ltd.

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