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Drug Registration In China-An overview of China Drug Registration Procedures 2009
Liang Kong, Feb 2009, Pages: 140
China is expected to be the fourth largest pharmaceutical market by 2010 as the average annual growth rate of China market has been above 15% since 1978. In 2008, the total pharmaceutical market size (including API, chemical finished product, biological product, and Traditional Chinese Medicine, and medicinal Instrument) in China was around USD 100 billion, and the chemical finished product market size was around USD 30 billion.
China pharmaceutical regulations are still under way to be streamlined and going to be more consistent with international standards. Previously, one of the major concerns from the global pharmaceutical companies is that the lengthy approval process in China. Nowadays, it changes better and better, followed by the major revision in Oct, 2007, the On-site Inspection for Drug Registration was introduced on May 2008, and the newly regulation of “Special Drug Review Approval Process” & Re-registration of Imported Drugs was introduced in Jan 2009.
In recognition of this major regulatory change in the daily-growing Chinese pharmaceutical market, How to register drugs in China: A comprehensive overview of procedures, a report that clearly and comprehensibly provides a detailed overview of the procedures necessary to register medicines in the Chinese market. It also provides you with the latest strategies to get your products registered in China soon.
Starting with an explanation for the key changes to drug registration procedure in 2007 the report includes details on the new regulatory articles including: The significant changes in the new report.
In what kind of conditions that the review process will be accelerated? What kind of drugs could be submitted as special review drugs? What’s the lasted requirement for re-registration for imported drugs in 2009 regulation?
How to prepare the submission dossiers for both international companies that already entering China & those that haven’t explored into China. This expert report contains:
-Full explanation of the drug registration procedure and regulations governing the process
-In-depth analysis of the regulations surrounding the drug registration for imported drugs.
-Comprehensive detail on submission requirements for biologics, Chinese medicines, generics, imported medicines, OTCs, and supplementary products.
Who will benefit from this report?
-Foreign drug companies considering a market entry in China
-Individuals with an interest in understanding the latest Chinese regulations on application and approval for imported drug registration.
-Regulatory affairs professions with responsibility for China
-The report will also be an essential reference document for any company library.
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