Pharmaceuticals

China Pharmaceutical Guidebook Series (2) (2013 Edition) Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Chemical Drugs

  • ACC795
  • 121 Pages
  • April 2013
  • Pharmaceuticals

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 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 the latest 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 constantlychanged, because the amendment of “Measures” is delayed. Under such circumstance, Access China Management Consulting Ltd published the China Pharmaceutical Guidebook Series: 2013 Edition. The aim of this guidebook series is to guide overseas pharmaceutical manufacturers and producers to achieve a successful application and approval for their imported drug registration. This guidebook series are composed of four guidebooks as the following.




  • Latest Chinese Regulations for Imported Drug Registration: 2013 Edition A Comprehensive Guidebook for Foreign Pharmaceutical Companies

  • Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: 2013 Edition A Guidebook for Application of Imported Chemical Drugs Registration

  • Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: 2013 Edition A Guidebook for Application of Imported Biological Product Registration

  • Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: 2013 Edition A Guidebook for Application of Imported Traditional Chinese Medicine and Natural Medicine Registration



 In this guidebook series, overseas pharmaceutical manufacturers and producers can easily find out every answer that they will meet question during process of application and approval for their imported drug registration. Access China Management Consulting Ltd hopes this China Pharmaceutical Guidebook Series, based on full and accurate regulations and law, can help guide overseas pharmaceutical manufacturers and producers to achieve a successful application and approval for their imported drug registration in China.



Executive Summary



This is the second guidebook of the China Pharmaceutical Guidebook Series. It will provide a detailed introduction of SFDA’s requirements for materials and clinical trials of application and approval for imported chemical drug registration, including radioactive pharmaceuticals.



Report Highlights




  • An overview of the classification of drug registration formulated by the SFDA (The State Food and Drug Administration in China).

  • The material items for application of drug registration.

  • The requirements of material items for application of drug registration.

  • The requirements of clinical trial for application of drug registration.

  • The material and clinical trial requirements for application of radioactive pharmaceuticals

  • The significant suggestions for overseas pharmaceutical manufacturers and producers looking to achieve a successful application for their chemical drug registration in China.

  • Many useful resources of law and regulations, including the Drug Administration Law of the People’s Republic of China, the Regulations for Implementation of the Drug Administration Law of the People’s Republic of China, the Chinese Good Clinical Practice of Pharmaceutical Products, 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 and approval for imported drug registration.

  • Senior executive officers engaging regulatory and registration affairs for drugs.


Please Select Format

Enquiry About Report

Need More Information

Contact us
+ 1-800-910-6452
+1-971-202-1575
+91 20 66346066
--- or ---
help@bigmarketresearch.com

 

UPCOMING MARKET RESEARCH REPORTS

Global General Medicine Education Publishing Market (Type, Geography) Size, Share, Global Trends, Company Profiles, Demand, Insights, Analysis, Opportunities, Segmentation, Forecast (2013-2020)

General medicine is a branch of medicine that deals with diagnosis and treatment of diseases associated with internal organs. It is also called as Internal Medicine. General medicine education market has shown substantial growth due to the adoption of internal medicine as a career option by medical students.

July 2017 | $5370 | Pre Book Price:$4699

Cancer Vaccine Market Global Scenario, Market Size, Outlook, Trend and Forecast, 2015- 2024

Cancer vaccines are biological response modifiers. These vaccines work by stimulating or restoring the immune system�s ability to fight against infections and diseases. It is used either as stand-alone therapies ...

July 2017 | $4995 | Pre Book Price:$4371

World Active Pharmaceutical Ingredient (API) Market - Opportunities and Forecasts, 2014 - 2020

Increase in Abbreviated New Drug Applications (ANDA) over the past years has fostered the demand for API market. Furthermore, Indian companies making increased entries related to Drug Master File (DMF) ...

July 2017 | $5370 | Pre Book Price:$4699

Anterior Uveitis Asia-Pacific Market Research Report, 2014 - 2020

Anterior uveitis is an eye inflammation that involves middle layer of the eye specifically, iris (colored part of the eye) and ciliary body (adjacent tissue). Untreated anterior uveitis results in ...

July 2017 | $2850 | Pre Book Price:$2494

Nanomedicine Asia-Pacific Market Research Report, 2014 - 2020

Nanomedicine is the applied branch of nanotechnology. Application of nanomedicines ranges from nonmaterial to nanoelectronic and in the near future, it could possibly expand to molecular nanotechnology. Biological, pharmaceutical and ...

July 2017 | $2850 | Pre Book Price:$2494

Autoimmune Disorders Treatment Asia-Pacific Market Research Report, 2014 - 2020

Graves disease, Multiple sclerosis, Myasthenia gravis, Rheumatoid arthritis, Pernicious anemia and Systemic lupus erythematosus are the most prevalent types of autoimmune disorders. The prevalence of autoimmune diseases is high in ...

July 2017 | $2850 | Pre Book Price:$2494

2017 © Copyright Big Market Research

View Pricing >>