Summary
Executive Summary
The traditional medicines in Orient, especially, the traditional Chinese medicines are always regarded by occidental as mysterious medicines. Until today not only the chemical composition of traditional Chinese medicines almost can not been expressed by a precise chemical structural formula, but also the indications of the majority of traditional Chinese medicines still can not been clearly described by the modern medical terminologies. How the Chinese pharmaceutical authorities to administer the registration application for such mysterious traditional Chinese 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 medicine. The Chinese pharmaceutical authorities collect the traditional Chinese medicines and the natural medicines into a category for registration application. Therefore, this guidebook will provide not only the introduction for registration application of imported traditional Chinese medicines but for the natural medicines.
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 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 applicant to not only submit designated material items in accordance with prescribed category of traditional Chinese medicines and natural medicines to apply for registration, but also conduct the clinical trials for certain categorical traditional Chinese medicines and natural medicines.
In this guidebook, 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, 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 medicine and natural medicine registration. The SFDA collected all materials for application of traditional Chinese medicine and natural medicine registration into four categories and 33 items, that is the comprehensive materials, the research materials of pharmaceutics, the research materials of pharmacology and toxicology, and the materials of clinical investigation. For administrative requirement of traditional Chinese medicine and natural medicine registration, the SFDA provides the detailed explanations for many material items 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 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 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 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 further explain the requirements of material items for various categorical traditional Chinese 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 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,that is 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 achieve a successful application for their traditional Chinese medicine and natural medicine registration in China. Last, the appendices in chapter 7 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 application of imported traditional Chinese medicine and natural medicine registration. For the detailed pathway and procedure for application and approval of imported drug registration, 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.
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:-
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.
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