China Pharmaceutical Regulation (2)

Access China Report

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 (2) (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 Chemical Drugs

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

Copy right © Access China Management Consulting Ltd.

1

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



Registration:

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

A Guidebook of Registration Application for Imported Biological Products 

The material items for application of drug registration.



The requirements of material items for application of drug registration.



The requirements of clinical trial for application of drug registration.



The material and clinical trial requirements for application of radioactive pharmaceuticals

 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.

2

Access China Report 

The significant suggestions for overseas pharmaceutical manufacturers and producers

This is the second guidebook of the China Pharmaceutical Guidebook Series. It will provide

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

a detailed introduction of SFDA’s requirements for materials and clinical trials of application and approval for imported chemical drug registration, including radioactive pharmaceuticals.

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

Chapter 2 provides an overview of the classification of drug registration that is formulated by

Pharmaceutical Products, the Chinese Good Manufacturing Practice for Pharmaceutical

the SFDA. To understand this classification of drug registration only is the first step for an

Products, the Form of Registration Application for Imported Drug, and so on.

application of chemical 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 chemical drug registration. The SFDA collected all materials for application of chemical drug registration into four categories and 32 items. There are the comprehensive

Who should buy this report?

materials, the research materials of pharmaceutics, the research materials of pharmacology and toxicology, and the materials of clinical investigation. For administrative requirement of chemical drug registration, the SFDA provides the detailed explanations for many material items and

•

Companies wishing to enter a lucrative drug market in China.

•

Companies interested in understanding the latest Chinese regulations on application 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 chemical drug registration of various categories in accordance with the material item’s ordinal numeral. Therefore, to understand the

approval for imported drug registration. •

material items is the second step for application of chemical drug registration. Chapter 4

Senior executive officers engaging regulatory and registration affairs for drugs.

introduces the requirements of material items for application of chemical 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 chemical drug

Executive Summary

registration stipulated by the SFDA. The explanatory notes further explain the requirements of

In China, like in other Western countries, the pharmaceutical authority ----- the SFDA

material items for various categorical chemical drugs. To understand the contents of this section

requests applicant to submit complicate and reliable materials for application of drug

is a core for application of chemical drug registration. The application of imported chemical drug

registration. The SFDA stipulated the classification of drug registration in order to administer the

registration must accord with the material items prescribed by the form of material Items and the

application of chemical drug registration. At the same time, the SFDA collected the materials for

explanatory notes to submit materials. Chapter 5 addresses the requirements of clinical trial for

application of chemical drug registration into four categories and 32 items in accordance with

application of chemical drug registration. There are two parts, i.e. the general requirements of

various chemical drug categories. When an application of chemical drug registration is filed, the

clinical trial and the special requirements of clinical trial for imported chemical drug. Chapter 6

SFDA will request applicant to not only submit designated material items in accordance with

introduces the material and clinical trial requirements for application of radioactive

prescribed category of chemical drug to apply for registration, but also conduct the clinical trials

pharmaceuticals, from the definitions, the requirements of material items, the explanatory notes

for certain categorical chemical drugs.

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

Copy right © Access China Management Consulting Ltd.

3

Access China Report China. Last, the appendices in chapter 8 include the Drug Administration Law of 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 Good Manufacturing Practice for Pharmaceutical Products, the Form of Registration Application for Imported Drug, references, a useful resources of URL, author’s biography, and description of

Access China Order Form

Access China Management Consulting Ltd.

After have skimmed through this guidebook,

audience canMaterial be clearly aware ofTrial theRequirements latest Chineseof regulations Title: and Clinical Applicationon andrequirements Approval forof the Imported Drug materials and the clinical trials for application of Registration: imported chemical drug registration. For the A Guidebook of Registration Application for Imported Chemical Drugs detailed pathway and procedure for application and approval of imported drug registration, Pharmaceutical Guidebook Series (2) (3rd edition) audience can learnChina from the first guidebook of the China Pharmaceutical Guidebook Series ---Latest Chinese Regulations for Imported Drug Registration: A Comprehensive Guidebook for Published Date: October 2007 Foreign Companies. Page Pharmaceutical Count: 144 Unit Price: US$ 750 Site License: US$3500 Format: Electronic PDF copy Please send me ___________Copy/ies Table of Contents Payment: Pay by bank wire transfer to: Account Number: 4447803-007000-900079468 Swift Code: BKCHCNBJ 940 Preface............................................................................................................................. ...................1 SUB-BRANCH Bank Name: BANK OF CHINA, NANJING SAJIAWAN Bank Address: 212 ZhongShan Beilu Road, Nanjing , People’s Republic Table of Contents........................................................................................................................ .......4 of China

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.

Delivery Details Title: ______________________ Full name: ____________________________ Job title: ___________________ Organization: ___________________________

At present, company provides consulting services for foreign clients as follows.

Email Address: ____________________________________________________

 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

Postal Address: ____________________________________________________ Postal/Zip code: _________________ Country: __________________________ Phone number: ___________________ Fax number: ______________________ Signed: _________________________ Date: ____________________________ 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. Copy right © Access China Management Consulting Ltd.

4

Access China Report 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.

Copy right © Access China Management Consulting Ltd.

5