URCH Publishing Releases Market Report On China's Pharmaceutical Regulations
LONDON --(Business Wire)-- URCH Publishing provides comprehensive insight into China's 2007 revised pharmaceutical regulations.
URCH Publishing Ltd. launches a major market study covering the ever-expanding Chinese pharmaceutical market. Drug Registration in China: A comprehensive overview of procedures offers a detailed analysis of the procedures required to register medicines in the Chinese market.
Expected to be the fourth largest pharmaceutical market by 2010, the average annual growth rate of China's pharmaceutical market has been above 15% since 1978.
The revised Drug Registration Procedure was introduced on 10 July 2007 at which point some changes were made to the current practice, as there were loopholes in the previous regulations. The new regulation comprises 15 chapters with 177 articles.
The main revisions to the regulations include provisions to:
- Strengthen the safety requirements for the drug.
- Specify the responsibility and strengthen the supervisory system.
- Increase registration standards and encourage novel drug research.
In recognition of this major regulatory change in the growing Chinese pharmaceutical market, the 148-page report comprehensibly provides a detailed overview of the procedures necessary to register a medicine in the Chinese market.
The 51,000 word report is invaluable to foreign drug companies considering a market entry in China, as well as individuals with an interest in understanding the latest Chinese regulations on application and approval for imported drug registration. It will also be a key reference to regulatory affairs professions with responsibility for China and an essential reference for any company library.
Highlights of the report include:
- Full explanation of the drug registration procedure and regulations governing the process
- An outline of the major responsibilities of the State Food and Drug Administration (SDFA)
- In-depth analysis of the regulations surrounding the drug registration for imported drugs.
- Comprehensive detail on applications for biologics, Chinese medicines, generics, imported medicines, OTCs and supplementary products.
- Summary of requirements for the application material for Traditional Chinese Medicines and natural drugs.
More information about Drug Registration in China: A comprehensive overview of procedures can be found at http://www.urchpublishing.com/publications/regulatory/drug_registr ation_china.html
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About URCH Publishing Ltd.
URCH Publishing Ltd is an independent business information publisher dedicated to delivering quality information products to the global pharmaceuticals industry. The company is based in London, UK. For more information contact URCH Publishing on +44 (0) 20 7060 1099 or email press[a]urchpublishing.com.
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