China Pharmaceutical Regulatory Report 2008 : Market Research Report

China Pharmaceutical Regulatory Report 2008

Published by: Pacific Bridge Medical

Published: Apr. 2, 2008 - 174 Pages

I. China Pharmaceutical Industry Overview: A. Overview; B. Brief Overview of China's Pharmaceutical Regulations; C. The State Food and Drug Administration
II. The China Healthcare System: A. History of Healthcare System in China; B. Struggling Healthcare Services Sector; C. Hospitals and Medical Resources; D. Health Insurance in China
III. Drug Registration Regulations: A. Drug Registration Policy; B. Classification of Drugs; C. Drug Registration Application; D. Application Documents for New Drug Registration; E. Technical Review Guidance for Registration Documents; F. New Drug Registration Process; G. OTC New Drug Registration Process
IV. Drug Pricing Regulations: A. Overview of Drug Pricing; B. Controls on Drug Pricing; C. National Essential Medical Insurance Drug List
V. Pharmaceutical Research and Development and Related Regulations: A. China's Research and Development Climate; B. Clinical Research; C. Good Clinical Practice (GCP); D. GCP-Certified Clinical Research Centers; E. Good Laboratory Practice (GLP); F. Adverse Event Reporting Requirements
VI. Pharmaceutical Manufacturing Regulations: A. Manufacturing Pharmaceuticals in China; B. GMP Regulations; C. GMP Certification; D. Drug Manufacturing Administration; E. Drug Manufacturing Certificate
VII. Selling Pharmaceuticals and Related Regulations: A. WTO Agreement on Drug Sales; B. Drug Sales to Hospitals; C. Selling Drugs in Drug Stores; D. Drug Sales on the Internet; E. Distribution Regulations; F. OTC Drug Sales; G. Regulations on Drug Imports
VIII. Marketing Drugs in China: A. Packaging Requirements
IX. Drug Advertising
X. Intellectual Property Protection: A. Current Intellectual Property Situation in China Pharmaceutical Market; B. Examples of Pharmaceutical Companies Experience with IPR infringement in China; C. Administration Protection (AP)
XI. Conclusion
APPENDICES:: Application Form for Drug Registration; Listing of CROs in China; Regulatory Specifics for Clinical Trials in China; Administrative Provisions for Drug Registration (translated law); Registration for TCM (translated law); Registration for Chemical Drugs (translated law); Registration for Biological Drugs (translated law); Supplemental Drug Application Registration (translated law); Drug Re-registration Application (translated law); Drug Monitoring Periods; Application and Approval Procedures and Timeline for Imported Drugs; Application and Approval Procedures and Timeline for Clinical Trials; Listing of SFDA-affiliated organizations in China; Healthcare statistics in Asia (charts)

Abstract

This report includes a brief overview of the pharmaceutical and healthcare industry in China, as well as a discussion of all the relevant laws and regulations that govern the testing, registration, manufacture, import, marketing, and sale of pharmaceutical products. Specific topics include: product registration, pricing and reimbursement, importation, GMP, GCP, orphan drugs, and intellectual property protection.

This report’s appendix contains a full translation of the revised Administrative Provisions for Drug Registration, the overhauling of China’s drug regulations that just came into effect on October 1, 2007. It also contains the annexes to this document detailing dossier submission requirements, all up-to-date.

You can purchase the 53-page report for $750. For $1,500, you can purchase the report plus the 125-page appendix including translations of key pharmaceutical regulations, pharmaceutical statistics, registration forms, China CRO contacts, and a timeline for the pharmaceutical registration process.

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China Pharmaceutical Regulatory Report 2008

Table of Contents

Abstract