China Pharmaceutical Guidebook Series (4) Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Biological Products - Biologics Market Research

China Pharmaceutical Guidebook Series (4) Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Biological Products
Access China Management Consulting Ltd.
July 1, 2006
65 Pages
Pub ID: ACCH1308139
US $750.00 Online Download
US $3,500.00 Global Site License

Abstract
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.
Additional Information
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 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 a serial of existing 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.