DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/30f00c/drug_registration) has announced the addition of the "Drug Registration in China - A Comprehensive Overview of Procedures" report to their offering.
Provides comprehensive insight into China's 2007 revised pharmaceutical regulations
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.
The revised Drug Registration Procedure was introduced on 10 July 2007, coming into effect on 1 October 2007, at which point some changes were made to the current practice, as there were loopholes in the previous regulations.
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 to encourage novel drug research.
In recognition of this major regulatory change in the ever-growing Chinese pharmaceutical market, URCH Publishing presents Drug Registration in China: A comprehensive overview of procedures, a 51,000 word report that clearly and comprehensibly provides a detailed overview of the procedures necessary to register a medicines in the Chinese market.
Starting with an explanation for the key changes to drug registration procedure in 2007 the 148 page report includes details on the new regulatory articles including:
- State Food and Drug Administration (SFDA)
- The openness policy and greater responsibilities of the SFDA
- Definition of re-registration and its procedures
- National economic policy
- Manufacturing process management
- Clinical trial supervision
- Dosage Form Change application requirements
- One-time submission of dossier
- More requirements of Drug Control Institute and CDE
- Clear responsibility for NICPBP during drug importation
- Drug name, packet insert and labels
- Non-approval of new drug application during re-consideration
- New penalty (fines and credit system)
- Situation to revoke the drug approval numbers.
For more information visit http://www.researchandmarkets.com/research/30f00c/drug_registration
Source: Spectra Intelligence