Navigation Links
China Regulatory and Market Access Pharmaceutical Report (2013)

NEW YORK, April 15, 2013 /PRNewswire/ -- announces that a new market research report is available in its catalogue:

China Regulatory and Market Access Pharmaceutical Report (2013)

China Regulatory and Market Access Pharmaceutical Report (2013)

China's pharmaceutical market is booming! The market is growing almost 15% annually and is expected to be about $100 billion dollars in 2017. This brand new report covers the best way to register your drug there and optimize market access to increase sales in China.

Drug regulations are complicated in China. This report discusses clinical trials, required drug documentation for approval, GCP, GMP, etc.

Once your drug is approved, what needs to be done to sell it in China? This report also covers issues like drug pricing, reimbursement, provincial bidding, hospital tenders, etc.

This report includes 17 appendices. They include application forms for pharmaceutical products, a list of Chinese CROs, the essential and national reimbursement drug lists, etc.

Pages: 282 (Including 98 pages of the basic report and 184 pages in the Appendix)


I. China Pharmaceutical Industry Overview

A. Overview
B. China Pharmaceutical Market Trends
C. China's Pharmaceutical Distribution System
D. Brief Overview of China's Pharmaceutical Regulations
E. China Food and Drug Administration (CFDA)

II. The China Healthcare System

A. History of China's Healthcare System
B. Struggling Healthcare Services Sector
C. 2009 Healthcare Reform
D. Hospitals and Medical Resources
1. Hospitals in China
2. Current Problems in the Hospital Sector
3. Private Investment in the Hospital Sector
4. Hospital Reform
E. Health Insurance in China

III. Drug Registration Regulations

A. Drug Registration Policy
B. Classification of Drugs
C. Drug Registration Applications
D. Application Documents for New Drug Registration
E. Technical Review Guidance for Registration Documents
F. New Drug Registration Process
G. Clinical Trials
H. Timeframe to get an Imported Drug Approved
I. OTC New Drug Registration Process
J. Drug Registration Re-Examination
K. Drug Registration Statistics
L. Classification of Combination Drug-Device Products
M. New Regulatory Changes

IV. Drug Pricing Regulations

A. Overview of Drug Pricing Policy
B. Controls on Drug Pricing
C. Reimbursement Drug Lists
D. NRDL and PRDL Pricing
E. Bidding and Hospital Listing

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. Overview of Manufacturing in China
B. Good Manufacturing Practice (GMP) Regulations
C. GMP Certification
D. Drug Manufacturing Administration
E. Drug Manufacturing Certificate
F. Biological Products

VII. Selling Pharmaceuticals and Related Regulations

A. WTO Agreement on Drug Sales
B. Drug Sales to Hospitals
C. Drug Purchasing System
D. Selling Drugs in Drug Stores
E. Internet Drug Sales
F. Distribution Regulations
1. Current Developments in Drug Distribution
2. Drug Distribution Policy
3. Renewal of Drug Distribution Licenses
G. OTC Drug Sales
H. Regulations on Importing Drugs
I. Drug Recalls
J. Drug Safety
K. Authorized Quality Person

VIII. Marketing Drugs in China and Related Regulations

A. Packaging Requirements

IX. Drug Advertising Regulations

X. Intellectual Property Protection and Patents

A. Intellectual Property in the China Pharmaceutical Market
B. Pharmaceutical Companies Experiencing IPR Problems
C. Administrative Protection (AP)

XI. Setting Up your Business in China

XII. What Other Companies are Doing in China

A. Joint Ventures (JV)
B. Acquisitions
C. Licensing

XIII. Conclusion


1. Application Form for Pharmaceutical Products
2. Listing of CROs in China
3. Regulatory Specifics for Clinical Trials in China
4. Administrative Provisions for Drug Registration (translated law)
5. Registration for TCM (translated law)
6. Registration for Chemical Drugs (translated law)
7. Registration for Biological Drugs (translated law)
8. Supplemental Drug Application Registration (translated law)
9. Drug Re-Registration Application (translated law)
10. Drug Monitoring Periods
11. Application and Approval Procedures and Timeline for Imported Drugs
12. Application and Approval Procedures and Timeline for Clinical Trials
13. Listing of CFDA-affiliated organizations in China
14. Healthcare Statistics and Pharmaceutical Markets in Asia (charts)
15. The National Essential Drug List (2013): Chemical and Biological Drugs
16. The National Essential Drug List (2009): Chemical and Biological Drugs
17. National Reimbursement Drug List (2009): Western Medicines

To order this report:
China Regulatory and Market Access Pharmaceutical Report (2013)

Contact Clare:
US:(339) 368 6001
Intl:+1 339 368 6001

SOURCE Reportlinker
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. X-BODY Announces Multi-Million Dollar Development Alliance With Jiangsu Hengrui Medicine Co., Ltd., A Leading Pharmaceutical Company In China, To Develop Novel Therapeutic Antibodies For AMD
2. Will Brazil, Russia, India and China Ever Become the Golden Goose of the Future for Life Science and Medical Device Companies?
3. Mindray Medical to Exhibit New Products at 69th China International Medical Equipment Fair
4. China Botanic Pharmaceutical Inc. Announces Receipt of Notice of Failure to Satisfy Continued Listing Letter
5. China Nepstar Chain Drugstore Reports Fourth Quarter and Fiscal Year 2012 Financial Results
6. Doing Business in China: Research on Chinese Good Manufacturing Practice Regulations for Medical Devices
7. Pharmaceutical Manufacturing in China
8. TriReme Announces Signing of a Master Distribution Agreement in China
9. Cellular Biomedicine Group Marks the Launch of China Clinical Trial for TC-DC Therapy for Hepatocellular Carcinoma
10. Pharma Site Inspection Case Sharing at CPhI China Onsite Forum
11. China Human Immunoglobulin Market & 2013 Beverage Forecasts
Post Your Comments:
(Date:6/24/2016)... and SAN CLEMENTE, Calif. , June 24, ... -based mobile pulmonary function testing company, is now able to perform ... developed by ndd Medical Technologies , Inc. ... in hospital-based labs.  Thanks to ndd,s EasyOne PRO ® , ARL ... can get any needed testing done in the comfort of her ...
(Date:6/24/2016)... , June 24, 2016  Arkis BioSciences, a ... invasive and more durable cerebrospinal fluid treatments, today ... The Series-A funding is led by Innova Memphis, ... and other private investors.  Arkis, new financing will ... and the market release of its in-licensed Endexo® ...
(Date:6/23/2016)... 2016  In a startling report released today, National Safety ... lacking a comprehensive, proven plan to eliminate prescription opioid overdoses. ... how states are tackling the worst drug crisis in recorded U.S. ... Kentucky , New Mexico , ... Of the 28 failing states, three – Michigan ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... 2016 , ... Conventional wisdom preaches the benefits of moderation, whether it’s a ... the bar too high can result in disappointment, perhaps even self-loathing. However, those who ... , Research from reveals that behind the tendency to set ...
(Date:6/24/2016)... ... 2016 , ... Marcy was in a crisis. Her son James, eight, was out of control. ... and physically. , “When something upset him, he couldn’t control his emotions,” remembers Marcy. ... rocks at my other children and say he was going to kill them. If ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San ... Society and the Road To Recovery® program to drive cancer patients to and from ... adults to ensure the highest quality of life and ongoing independence. Getting to ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... to recognize Dr. Barry M. Weintraub as a prominent plastic surgeon and the ... in the world, and the most handsome men, look naturally attractive. Plastic surgery ...
(Date:6/24/2016)... ... June 24, 2016 , ... Venture Construction Group ... Tournament held on June 20th at the Woodmont Country Club at 1201 Rockville ... an organization dedicated to helping service members that have been wounded in battle and ...
Breaking Medicine News(10 mins):