China Pharmaceutical Guidebook Series (4) - Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration:

Preface

China possesses a fourth population in the world and has one of the largest drug markets round the world. By 2004, sales on the Chinese drug market have reached $9.5 billion dollars, an increase of 3 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 2004, sales of imported drugs have shared over 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. The latest �Measures for the Administration of Drug Registration� have entered into force since May 1, 2005. These �Measures� provide detailed requirements and procedures of application and approval for imported drug registration. Under such circumstance, Access China Management Consulting Ltd writes out 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 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.

Executive Summary

The biopharmaceutical industry is one of the burgeoning industries. In the field of biopharmaceuticals, vast knowledge awaits people to explore. The biopharmaceuticals are diversified and complex. In China, the development of biopharmaceutical industry is far behind the developed countries. Just for this reason, the requirements of materials and clinical trials for registration application of biopharmaceuticals stipulated by the Chinese pharmaceutical authority are far from systematic and uniform.

In China, the pharmaceutical authority ----- the SFDA (State Food and Drug Administration, China) divided the biopharmaceuticals for registration application into two classifications, that is the therapeutic biological products and the prophylactic biological products. However, in the classification of therapeutic biological products, the SFDA does not provide the uniform requirements of materials and clinical trials for application of biological products for the gene therapy, the somatic cell therapy and the allergic therapy, but stipulates the guidelines for them respectively. These guidelines provide only a common principle for them because of their diversity and complexity.

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 guidelines. The part one provides an introduction of the requirements for materials and clinical trials of registration application for imported therapeutic biological products. The part two introduces the requirements for materials and clinical trials of registration application for imported prophylactic biological products. The part three addresses the requirements for materials and clinical trials of registration application for imported gene therapeutic biological products and somatic cell therapeutic biological products. The part four addresses the requirements for materials and clinical trials of registration application for imported allergic therapeutic biological products.

The SFDA stipulated not only the classification of product registration but also the requirements for material items and clinical trials for various categorical biopharmaceuticals in order to administer the registration application for them. For every categorical biopharmaceuticals, to understand the classification of product registration only is the first step for a registration application of biological products, because applicant must file the application in accordance with the classification of biological product registration. The SFDA collected all materials submission for registration application of biological products into various items and preceded the ordinal numeral for every material item, moreover, every item includes many sub-items. When an application is filed, the SFDA will request applicant to submit the materials for registration application of biological products of various categories in accordance with the material item�s ordinal numeral. Therefore, to understand the material items is the second step 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 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 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 must accord with the material items prescribed by the form of material items and the explanatory notes to submit materials. In general, the requirements of clinical trial for registration application of biological products are two parts, that is the general requirements of clinical trial and the special 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 application for their biopharmaceuticals registration in China. Last, the appendices in chapter 14 include references, a useful resources of URL, author�s biography, and description of 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 materials and the clinical trials for registration application of 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 China Pharmaceutical Guidebook Series ---- Latest Chinese Regulations for Imported Drug Registration: A Comprehensive Guidebook for Foreign Pharmaceutical Companies.