Navigation Links
China Pharmaceutical Market Guidebook Series (4) 2013 Report
Date:5/22/2013

DALLAS, May 22, 2013 /PRNewswire-iReach/ -- MarketReportsOnline.com announces addition of new market research report "China Pharmaceutical Guidebook Series (4) 2013 Edition Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Traditional Chinese Medicines and Natural Medicines" to its online database.

The 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 fourth 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 Food and Drug Administration (hereafter called CFDA) requests applicant to submit complicate and reliable materials for application of medicine registration. The CFDA 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 CFDA 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 CFDA 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.

Order / Buy a copy of this report @ http://www.marketreportsonline.com/contacts/Purchase.aspx?name=239942.

Report (http://www.marketreportsonline.com/239942-china-pharmaceuti.html) Highlights :

  • An overview of the classification of medicine registration formulated by the CFDA (China 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 application for their traditional Chinese medicine and natural medicine 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.

Chapter 2 provides an overview of the classification of medicine registration that is formulated by the CFDA. 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 CFDA collected all materials for application of traditional Chinese medicine and natural medicine registration into four categories and 33 items, i.e. the summary 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 CFDA provides the detailed explanations for many material items and precedes the ordinal numeral for each material item. When an application is filed, the CFDA 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 medicine and natural medicine registration stipulated by the CFDA. The explanatory notes further explain the requirements of material items for various categorical traditional Chinese medicines and natural medicines. To understand the contents of this section is a core for application of traditional Chinese medicine and natural medicine registration. The application of imported traditional Chinese medicine and natural medicine registration must accord with the material items prescribed by the form of material Items and the explanatory notes to submit materials.

Chapter 5 addresses the requirements of clinical trial for application of traditional Chinese medicine and natural medicine registration. There are two parts, i.e. the general requirements of clinical trial and the special requirements of clinical trial for imported traditional Chinese medicines and natural medicines.

The guidebook concludes in chapter 6 by highlighting the significant suggestions for overseas pharmaceutical manufacturers and producers looking to achieve a successful application for their traditional Chinese medicine and natural medicine registration in China. Lastly, there are appendices in chapter 7.

Comprehensive Table of Contents and more @ http://www.marketreportsonline.com/239942-china-pharmaceuti.html.

Explore more reports on the Pharmaceuticals market @ http://www.marketreportsonline.com/cat/pharmaceuticals-market-research.html.

We also offer premium market research reports on multiple industries at http://www.reportsnreports.com/ and http://www.rnrmarketresearch.com/.

About Us:

MarketReportsOnline.com (http://www.marketreportsonline.com/) is an online market research reports library of 300,000+ in-depth studies of over 5000 micro markets. Our database includes reports by leading publishers from across the globe. We provide 24/7 online and offline support service to our customers.

Stay updated on latest premium market research reports by connecting with us on:

G+ : https://plus.google.com/u/0/111656568937629536321/posts.

Twitter: http://twitter.com/marketsreports.

Facebook: http://www.facebook.com/pages/ReportsnReports/191441427571689.

Media Contact:

Priyank Tiwari Market Reports Online, +1 888 391 5441, sales@marketreportsonline.com

News distributed by PR Newswire iReach: https://ireach.prnewswire.com


'/>"/>
SOURCE MarketReportsOnline.com
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Top buyers including Atico, Coles Group Asia, Kmart, Staples, Office Depot and Target Australia pre-registered to attend Global Sources spring China Sourcing Fairs
2. CentraState and Freehold Radiology Group train physicians from China
3. Johnson & Johnson (China) Investment Ltd. Acquires Guangzhou Bioseal Biotechnology Co., Ltd.
4. ResearchMoz: Global and China 4A Zeolite Industry 2012 Deep Research Report - Market Research Report
5. China Biologic Products to Host Earnings Conference Call on May 9, 2012 at 8:00 a.m. EDT (NY)
6. China Biologic Products Reports Higher Results for the First Quarter 2012
7. China Pharma Holdings, Inc. Reports First Quarter 2012 Financial Results
8. Osteoporosis Drug Market- Global And China Market Analysis, Size, Trends And Forecast (2010-2015)
9. China Botanic Attends 67th PHARMCHINA Fair
10. Xiangxue Pharmaceuticals to Acquire Rights for a Promising Drug Candidate from Kinex Pharmaceuticals for the Greater China Territory
11. China Botanic Attends the 111th China Import and Export Fair
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... Ontario , June 27, 2016  VMS Rehab ... Company,s Board will take whatever measures required to build ... Company,s stock which is currently listed on the OTC ... Wexler, Company Chairman and CEO, "We are seeing an ... difficult to understand, not only by the Company, but ...
(Date:6/24/2016)... 24, 2016  Global Blood Therapeutics, Inc. (GBT) (NASDAQ: ... novel therapeutics for the treatment of grievous blood-based ... closing of its previously announced underwritten public offering ... public offering price of $18.75 per share. All ... by GBT. GBT estimates net proceeds from the ...
(Date:6/24/2016)... June 24, 2016 The Academy of Managed ... recommendations that would allow biopharmaceutical companies to more ... that make formulary and coverage decisions, a move that ... new medicines. The recommendations address restrictions in ... on the drug label, a prohibition that hinders decision ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... ... announced its strategic partnership with Connance, a healthcare industry leader providing predictive ... proven, proprietary technology combine to provide health systems, hospitals and ambulatory surgical ...
(Date:6/26/2016)... ... June 26, 2016 , ... Pixel Film Studios Released ProSlice Levels, a Media ... give their videos a whole new perspective by using the title layers in ... Studios. , ProSlice Levels contains over 30 Different presets to choose from. ...
(Date:6/25/2016)... ... ... Austin residents seeking Mohs surgery services, can now turn to Dr. Jessica ... Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization to include Mohs ... Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction of Glenn Goldstein, ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin Johnson has dedicated ... has implemented orthobiologic procedures as a method for treating his patients. The procedure ... doctors to perform the treatment. Orthobiologics are substances that orthopaedic surgeons use to ...
(Date:6/24/2016)... , ... June 24, 2016 , ... June 19, 2016 ... dangers associated with chronic pain and the benefits of holistic treatments, Serenity Recovery ... are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) is a disorder ...
Breaking Medicine News(10 mins):