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China Pharmaceutical Regulation (3) - 2009 Edition
China Pharmaceutical Regulation (3) - 2009 Edition
China Pharmaceutical Regulation (3) - 2009 Edition
China Pharmaceutical Regulation (3) - 2009 Edition
China Pharmaceutical Regulation (3) - 2009 Edition
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China Pharmaceutical Regulation (3) - 2009 Edition

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Executive SummaryThe traditional medicines in Orient, especially, the traditional Chinese medicines are always regarded by occidental as mysterious medicines. Until today not only the chemical …

Executive SummaryThe 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 drug 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.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, i.e. 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 medici

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  1. Find Industry reports, Company profilesReportLinker and Market Statistics >> Get this Report Now by email!China Pharmaceutical Regulation (3) - 2009 EditionPublished on May 2009 Report SummaryExecutive SummaryThe traditional medicines in Orient, especially, the traditional Chinese medicines are always regarded by occidental as mysteriousmedicines. Until today not only the chemical composition of traditional Chinese medicines almost can not been expressed by aprecise chemical structural formula, but also the indications of the majority of traditional Chinese medicines still can not been clearlydescribed by the modern medical terminologies. How the Chinese drug authorities to administer the registration application for suchmysterious traditional Chinese medicines This is the third guidebook of the China Pharmaceutical Guidebook Series. It will provide adetailed introduction of the Chinese pharmaceutical authorities requirements for materials and clinical trials of application andapproval for imported traditional Chinese medicine. The Chinese pharmaceutical authorities collect the traditional Chinese medicinesand the natural medicines into a category for registration application. Therefore, this guidebook will provide not only the introductionfor 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 (hereaftercalled SFDA) requests applicant to submit complicate and reliable materials for application of medicine registration. The SFDAstipulated the classification of medicine registration in order to administer the application of traditional Chinese medicine and naturalmedicine registration. At the same time, the SFDA collected the materials for application of traditional Chinese medicine and naturalmedicine registration into four categories and 33 items in accordance with various medicine categories. When an application oftraditional Chinese medicine and natural medicine registration is filed, the SFDA will request applicant to not only submit designatedmaterial 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.Chapter 2 provides an overview of the classification of medicine registration that is formulated by the SFDA. To understand thisclassification of medicine registration only is the first step for an application of traditional Chinese medicine and natural medicineregistration, because applicant must file the application in accordance with this classification of medicine registration. Chapter 3addresses the material items for application of traditional Chinese medicine and natural medicine registration. The SFDA collected allmaterials for application of traditional Chinese medicine and natural medicine registration into four categories and 33 items, i.e. thecomprehensive materials, the research materials of pharmaceutics, the research materials of pharmacology and toxicology, and thematerials of clinical investigation. For administrative requirement of traditional Chinese medicine and natural medicine registration, theSFDA provides the detailed explanations for many material items and precedes the ordinal numeral for each material item. When anapplication is filed, the SFDA will request applicant to submit the materials for application of traditional Chinese medicine and naturalmedicine registration of various categories in accordance with the material items ordinal numeral. Therefore, to understand thematerial items is the second step for application of traditional Chinese medicine and natural medicine registration. Chapter 4introduces the requirements of material items for application of traditional Chinese medicine and natural medicine registration in termsof the form of material items and their explanatory notes. The form of material items represents the current requirements of materialitems for application of traditional Chinese medicine and natural medicine registration stipulated by the SFDA. The explanatory notesfurther explain the requirements of material items for various categorical traditional Chinese medicines and natural medicines. Tounderstand the contents of this section is a core for application of traditional Chinese medicine and natural medicine registration. Theapplication of imported traditional Chinese medicine and natural medicine registration must accord with the material items prescribedby the form of material Items and the explanatory notes to submit materials. Chapter 5 addresses the requirements of clinical trial forapplication of traditional Chinese medicine and natural medicine registration. There are two parts, i.e. the general requirements ofChina Pharmaceutical Regulation (3) - 2009 Edition Page 1/5
  2. Find Industry reports, Company profilesReportLinker and Market Statisticsclinical trial and the special requirements of clinical trial for imported traditional Chinese medicines and natural medicines. Theguidebook concludes in chapter 6 by highlighting the significant suggestions for overseas pharmaceutical manufacturers andproducers looking to achieve a successful application for their traditional Chinese medicine and natural medicine registration in China.Last, the appendices in chapter 7 include the Drug Administration Law of the Peoples Republic of China, the Regulations for the DrugAdministration Law of the Peoples Republic of China, the Chinese Good Clinical Practice of Pharmaceutical Products, the ChineseGood Manufacturing Practice for Pharmaceutical Products, the Form of Registration Application for Imported Drug, references, auseful resources of URL, authors biography, and description of Access China Management Consulting Ltd. After have skimmedthrough this guidebook, audience can be clearly aware of the latest Chinese regulations on requirements of the materials and theclinical trials for application of imported traditional Chinese medicine and natural medicine registration. For the detailed pathway andprocedure for application and approval of imported drug registration, audience can learn from the first guidebook of the ChinaPharmaceutical Guidebook Series ---- Latest Chinese Regulations for Imported Drug Registration: A Comprehensive Guidebook forForeign Pharmaceutical Companies.Report Highlights- An overview of the classification of medicine registration formulated by the SFDA (State Food and Drug Administration in China).- The material items for application of medicine Registration.- The requirements of material items for application of medicine registration.- The requirements of clinical trial for application of medicine registration.- The significant suggestions for overseas pharmaceutical manufacturers and producers looking to achieve a successful applicationfor their traditional Chinese medicine and natural medicine registration in China.- Many useful resources of law and regulations, including the Drug Administration Law of the Peoples Republic of China, theRegulations for Implementation of the Drug Administration Law of the Peoples Republic of China, the Chinese Good Clinical Practiceof Pharmaceutical Products, the Chinese Good Manufacturing Practice for Pharmaceutical Products, the Form of RegistrationApplication 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 and approval for imported drug registration.- Senior executive officers engaging regulatory and registration affairs for drugs. Table of ContentTable of Contents 1Preface 2Chapter 1. Introduction 4Chapter 2. Classification of Medicine Registration 72.1. Definitions 72.2. Classification of Medicine Registration 8Chapter 3. Material Items for Application of Medicine Registration 113.1. Comprehensive Materials 12China Pharmaceutical Regulation (3) - 2009 Edition Page 2/5
  3. Find Industry reports, Company profilesReportLinker and Market Statistics3.2. Research Materials of Pharmaceutics 143.3. Research Materials of Pharmacology and Toxicology 163.4. Materials of Clinical Investigation 18Chapter 4. Requirements of Material Items for Application of Medicine Registration 204.1. Definitions 204.2. The Form of Material Items 21Chapter 5. Requirements of Clinical Trial for Application of Medicine Registration 295.1. General Requirements of Clinical Trial 295.2. Special Requirements of Clinical Trial for Imported Medicines 31Chapter 6 Conclusion. 32Chapter 7. Appendices 347.1. The Drug Administration Law of the Peoples Republic of China 347.2. The Regulations for Implementation of the Drug Administration Law of the Peoples Republic of China 627.3. The Good Clinical Practice of Pharmaceutical Products 897.4. The Good Manufacturing Practice for Pharmaceutical Products 1097.5. Form of Registration Application for Imported Drug 1287.6. References 1337.7. Resources 1347.8. Authors Biography 1367.9. Companys Description 137China Pharmaceutical Regulation (3) - 2009 Edition Page 3/5
  4. Find Industry reports, Company profilesReportLinker and Market Statistics Fax Order Form To place an order via fax simply print this form, fill in the information below and fax the completed form to: Europe, Middle East and Africa : + 33 4 37 37 15 56 Asia, Oceania and America : + 1 (805) 617 17 93 If you have any questions please visit http://www.reportlinker.com/notify/contact Order Information Please verify that the product information is correct and select the format(s) you require. China Pharmaceutical Regulation (3) - 2009 Edition Product Formats Please select the product formats and the quantity you require. 1 User License--USD 750.00 Quantity: _____ Site License--USD 3 500.00 Quantity: _____ Contact Information Please enter all the information below in BLOCK CAPITALS Title: Mr Mrs Dr Miss Ms Prof First Name: _____________________________ Last Name: __________________________________ Email Address: __________________________________________________________________________ Job Title: __________________________________________________________________________ Organization: __________________________________________________________________________ Address: __________________________________________________________________________ City: __________________________________________________________________________ Postal / Zip Code: __________________________________________________________________________ Country: __________________________________________________________________________ Phone Number: __________________________________________________________________________ Fax Number: __________________________________________________________________________China Pharmaceutical Regulation (3) - 2009 Edition Page 4/5
  5. Find Industry reports, Company profilesReportLinker and Market Statistics Payment Information Please indicate the payment method, you would like to use by selecting the appropriate box. Payment by credit card Card Number: ______________________________________________ Expiry Date __________ / _________ CVV Number _____________________ Card Type (ex: Visa, Amex…) _________________________________ Payment by wire transfer Crédit Mutuel RIB : 10278 07314 00020257701 89 BIC : CMCIFR2A IBAN : FR76 1027 8073 1400 0202 5770 189 Payment by check UBIQUICK SAS 16 rue Grenette – 69002 LYON, FRANCE Customer signature:   Please note that by ordering from Reportlinker you are agreeing to our Terms and Conditions at http://www.reportlinker.com/index/terms Please fax this form to: Europe, Middle East and Africa : + 33 4 37 37 15 56 Asia, Oceania and America : + 1 (805) 617 17 93China Pharmaceutical Regulation (3) - 2009 Edition Page 5/5

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