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China Pharmaceutical Guidebook Add

China Pharmaceutical Guidebook Add

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Published by AccessChina
Access China Research
Access China Research

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Published by: AccessChina on Oct 21, 2008
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Access China ReportExecutive Summary
China possesses a fourth population in the world and has one of the largest drug markets roundthe world. By 2006, sales on the Chinese drug market have reached $12 billion dollars, anincrease of 3.8 fold over 1998 level. A series of factors, such as an increasingly ageingpopulation, accelerating growth of urban population as well as expansion of healthcare coveringurban 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 worldby 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 afillip to the imported drugs from overseas pharmaceutical manufacturers and producers. By2006, sales of imported drugs have shared one fifth on the Chinese drug market. As China joinsthe World Trade Organization (WTO) and integrates more completely into the global economy, itwill further open the door to a lucrative drug market for overseas pharmaceutical companies.More and more overseas pharmaceutical manufacturers and producers expect to enter suchdrug 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 filethe application for their imported drug registration with Chinese pharmaceutical authorities. InChina, the process of application and approval for imported drug registration is very complex,because the Chinese pharmaceutical authorities administer and control this process byexorbitant administrative measures and regulations, moreover, these exorbitant administrativeregulations are variable and lack of transparency. Therefore, a comprehensive and thoroughknowledge of the latest Chinese regulations for imported drug registration has been become anessential prerequisite for overseas pharmaceutical manufacturers and producers to achieve asuccessful application for their products entry into the Chinese drug market. In despite of sincethe drug registration implemented by the Chinese pharmaceutical authorities on December 1,2002, its regulatory regime has experienced countless changes, and become increasinglycompatible with international standards, in turn, its ongoing consolidation will eventuallycontribute to a healthier market environment. In July 2007, the Chinese pharmaceuticalauthorities promulgated the latest “Measures for the Administration of Drug Registration”, andthe latest “Measures” will enter into force since October 1, 2007. These “Measures” provide thelatest detailed requirements and procedures of application and approval for imported drugregistration. Under such circumstance, Access China Management Consulting Ltd publishedthis China Pharmaceutical Guidebook---- Latest Chinese Regulations for Imported DrugRegistration. The aim of this guidebook is to guide overseas pharmaceutical manufacturers andCopy right©Access China Management Consulting Ltd.
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China Pharmaceutical Guidebook guidesoverseas pharmaceutical manufacturers andproducers step by step to achieve a successfulapplication and approval for their importeddrug registration to enter a lucrative drugmarket in China.
 
Access China Report
producers to achieve a successful application and approval for their imported drug registration.This guidebook is composed of four main parts as the following.
A Comprehensive Guidance of Imported Drug Registration
A Guidance of Registration Application for Imported Chemical Drugs
A Guidance of Registration Application for Imported Biological Products
A Guidance of Registration Application for Imported Natural Medicines and TraditionalChinese MedicinesPart I provides a comprehensive guidance of imported drug registration, which introduces anoverview of the main responsibilities and organization structure of the Chinese pharmaceuticalauthority ---- State Food and Drug Administration (SFDA), the comprehensive regulations for imported drug registration in China, from the classification of drugs, definitions relating toapplication for imported drug registration, the application and approval for imported drugs andrepackaging of imported drugs, the supplementary application and re-registration for importeddrugs, the clinical investigation for application of imported drug registration to the time limits indrug registration, as well as the procedures of application and approval for imported drugregistration, including the procedures of the initial application and approval for imported drugs,the supplementary application and approval for imported drugs, and the application andapproval for clinical trials relating to imported drugs. All such knowledge in Part I is essential toachieve a successful application and approval for imported drug registration in China.In China, like in other Western countries, the pharmaceutical authority ---- SFDA requestsapplicant to submit complicate and reliable materials for application of imported drugregistration. Therefore, to achieve a successful application and approval for imported drugregistration in China, overseas pharmaceutical manufacturers and producers must understandthe more depth and detailed regulations on registration application for various imported drugs.Part II provides a guidance of registration application for imported chemical drugs, whichaddresses SFDA’s requirements for materials and clinical trials of application and approval for imported chemical drug registration, including radioactive pharmaceuticals, from theclassification of drug registration formulated by the SFDA, the material items for application of chemical drug registration, the requirements of material items for application of chemical drugregistration, the requirements of clinical trial for application of chemical drug registration to thematerial and clinical trial requirements for application of radioactive pharmaceuticals.Part III provides a guidance of registration application for imported biological products. Thebiopharmaceutical industry is one of the burgeoning industries. In the field of biopharmaceuticals, vast knowledge awaits people to explore. The biopharmaceuticals arediversified and complex. In China, the development of biopharmaceutical industry is far behindthe developed countries. Just for this reason, the requirements of materials and clinical trials for registration application of biopharmaceuticals stipulated by the Chinese pharmaceuticalauthority are far from systematic and uniform. In China, the SFDA divided thebiopharmaceuticals for registration application into two classifications, i.e. the therapeuticbiological 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 registration application of biological products for the gene therapy,the somatic cell therapy and the allergic therapy, but stipulates the other guidelines for them.Therefore, the requirements for materials and clinical trials of registration application for imported gene therapeutic biological products, imported somatic cell therapeutic biologicalproducts and imported allergic therapeutic biological products are addressed based on theseguidelines. Part III addresses the requirements of material items and clinical trials for registrationapplication of imported therapeutic biological products and prophylactic biological products, aswell as the imported biological products for the gene therapy, the somatic cell therapy and theallergic therapy, from the classification of therapeutic biological product and prophylacticbiological product registration formulated by the SFDA, the material items for registrationapplication of therapeutic biological products and prophylactic biological products, therequirements of material items for registration application of therapeutic biological products andprophylactic biological products, the requirements of clinical trial for registration application of therapeutic biological products and prophylactic biological products to the guideline for registration application of biological products for human gene therapy, the guideline for registration application of biological products for somatic cell therapy, and the guideline for registration application of biological products for allergic therapy.Part IV provides a guidance of registration application for imported natural medicines andtraditional Chinese medicines. The traditional medicines in Orient, especially, the traditionalChinese medicines are always regarded by occidental as mysterious medicines. Until today notonly the chemical composition of traditional Chinese medicines almost can not been expressedby a precise chemical structural formula, but also the indications of the majority of traditionalChinese medicines still can not been clearly described by the modern medical terminologies.How the Chinese pharmaceutical authorities to administer the registration application for suchmysterious traditional Chinese medicines? Part IV provides a detailed introduction of the SFDA’srequirements for materials and clinical trials of application and approval for imported traditionalChinese medicine. The SFDA collects the traditional Chinese medicines and the naturalmedicines into a category for registration application. Therefore, Part IV provides not only theintroduction for registration application of the imported traditional Chinese medicines but for thenatural medicines, from the classification of natural medicine and traditional Chinese medicineregistration formulated by the SFDA, the material items for registration application of naturalCopy right©Access China Management Consulting Ltd.
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Access China Report
medicines and traditional Chinese medicines, the requirements of material items for registrationapplication of natural medicines and traditional Chinese medicines to the requirements of clinicaltrial for registration application of natural medicines and traditional Chinese medicines.The guidebook concludes in Part V by highlighting the significant suggestions for overseaspharmaceutical manufacturers and producers looking to achieve a successful application for their drug registration in China. Last, the appendices in Part VI include the Drug AdministrationLaw of the People’s Republic of China, the Regulations for the Drug Administration Law of thePeople’s Republic of China, the Chinese Good Clinical Practice of Pharmaceutical Products, theChinese Good Manufacturing Practice for Pharmaceutical Products, the Form of RegistrationApplication for Imported Drug, references, a useful resources of URL, author’s biography, anddescription of Access China Management Consulting Ltd.More and more overseas pharmaceutical manufacturers and producers expect to acquire thelatest detailed information about the Chinese regulations for imported drug registration. In thisguidebook, overseas pharmaceutical manufacturers and producers can easily find out everyanswer that they will meet question during process of application and approval for their importeddrug registration in China. After have skimmed through this guidebook, audience can clearlyacquire a comprehensive and thorough knowledge of the latest Chinese regulations for importeddrug registration. Access China Management Consulting Ltd hopes this China PharmaceuticalGuidebook ---- Latest Chinese Regulations for Imported Drug Registration, based on full andaccurate regulations and law, can help guide overseas pharmaceutical manufacturers andproducers to achieve a successful application and approval for their imported drug registration inChina.
Report Highlights
An overview of the main responsibilities and organization structure of the SFDA (The StateFood and Drug Administration) that is current Chinese pharmaceutical authority at thecentral level, and takes responsible for application and approval for imported drugregistration.
The comprehensive regulations for imported drug registration in China, from theclassification of drugs, definitions relating to application for imported drug registration, theapplication and approval for imported drugs and repackaging of imported drugs, thesupplementary application and re-registration for imported drugs, the clinical investigationfor application of imported drug registration to the time limits in drug registration.
The procedures of application and approval for imported drug registration, including theprocedures of the initial application and approval for imported drugs, the supplementaryapplication and approval for imported drugs, and the application and approval for clinicaltrials relating to imported drugs.
A guidance of registration application for imported chemical drugs.
A guidance of registration application for imported biological products.
A guidance of registration application for imported natural medicines and traditional Chinesemedicines.
The significant suggestions for overseas pharmaceutical manufacturers and producerslooking to achieve a successful application for their drug registration in China.
Many useful resources of law and regulations, including the Drug Administration Law of thePeople’s Republic of China, the Regulations for Implementation of the Drug AdministrationLaw of the People’s Republic of China, the Chinese Good Clinical Practice of Pharmaceutical Products, the Chinese Good Manufacturing Practice for PharmaceuticalProducts, the Form of Registration Application for Imported Drug, and so on.
Who should buy this report?
 
Companies wishing to enter a lucrative drug market in China.
Companies interested in understanding the latest Chinese regulations on application andapproval for imported drug registration.
Senior executive officers engaging regulatory and registration affairs for drugs.
Table of Contents
Copy right©Access China Management Consulting Ltd.
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