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Jun 04,2013 : Bharat Book Bureau presents the new report, on 'China Pharmaceutical Guidebook: Latest Chinese Regulations for Imported Drug Registration' 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. Executive Summary
China possesses a fourth population in the world and has one of the largest drug markets round the world. By 2012, sales on the Chinese drug market have reached RMB 926.1billion (about US$147 billion) reported by the «2012: Report of China Pharmaceutical Market» published by Chinese Academy of Social Sciences. It is estimated that it will exceed RMB 1,000 billion by 2013. 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 over 20 percent per annum in next three years. China is expected to become the second largest drug market in the world by 2015.
Since the reform and open door policy implemented by the 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 2012, sales of imported drugs have shared one fourth 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 of 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 thelatest 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 the drug registration implemented by the Chinese pharmaceutical authorities on December 1, 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 promulgated the last “Measures for the Administration of Drug Registration” on July 10 2007, and the last “Measures” entered into force since October 1, 2007. However, the practical operations for application and approval of imported drug registration have been constantly changed, because the amendment of “Measures” is sluggish. Under such circumstance, Access China Management Consulting Ltd published the China Pharmaceutical Guidebook (2013 Edition): Latest Chinese Regulations for Imported Drug Registration. The aim of this guidebook is to guide overseas pharmaceutical manufacturers and producers to achieve a successful application and approval for their imported drug registration. This guidebook is composed of main four parts as the following.
Part I provides a comprehensive guidance of imported drug registration, which introduces an overview of the main responsibilities and organization structure of the Chinese pharmaceutical authority ---- China Food and Drug Administration (CFDA), the comprehensive regulations for imported drug registration in China, from the classification of drugs, definitions relating to application for imported drug registration, the application and approval for imported drugs and repackaging of imported drugs, the supplementary application and re-registration for imported drugs, the clinical investigation for application of imported drug registration to the time limits in drug registration, as well as the procedures of application and approval for imported drug registration, including the procedures of the initial application and approval for imported drugs, the supplementary application and approval for imported drugs, and the application and approval for clinical trials relating to imported drugs. All such knowledge in Part I is essential to achieve a successful application and approval for imported drug registration in China. In China, like in other Western countries, the pharmaceutical authority ---- CFDA requests applicant to submit complicate and reliable materials for application of imported drug registration. Therefore, to achieve a successful application and approval for imported drug registration in China, overseas pharmaceutical manufacturers and producers must understand the more depth and detailed regulations on registration application for various imported drugs.
Part II provides a guidance of registration application for imported chemical drugs, which addresses CFDA’s requirements for materials and clinical trials of application and approval for imported chemical drug registration, including radioactive pharmaceuticals, from the classification of drug registration formulated by the CFDA, the material items for application of chemical drug registration, the requirements of material items for application of chemical drug registration, the requirements of clinical trial for application of chemical drug registration to the material and clinical trial requirements for application of radioactive pharmaceuticals.
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