Research and Markets: China Pharmaceutical Guidebook: Chinese Regulations for Imported Drug Registration

DUBLIN--(Business Wire)--
Research and Markets
(http://www.researchandmarkets.com/research/6142d2/china_pharmaceutic) has
announced the addition of the "China Pharmaceutical Guidebook: Latest Chinese
Regulations for Imported Drug Registration" report to their offering.

Report Highlights

* An overview of the main responsibilities and organization structure of the
SFDA (The State Food and Drug Administration) that is current Chinese
pharmaceutical authority at the central level, and takes responsible for
application and approval for imported drug registration.
* The comprehensive regulations for imported drug registration in China, from
the classification of drugs, definitions relating to application for imported
drug registration, the application and approval for imported drugs and
repackaging of imported drugs, the supplementary application and re-registration
for imported drugs, the clinical investigation for application of imported drug
registration to the time limits in drug registration.
* The procedures of application and approval for imported drug registration,
including the procedures of the initial application and approval for imported
drugs, the supplementary application and approval for imported drugs, and the
application and approval for clinical trials relating to imported drugs.
* A guidance of registration application for imported chemical drugs.
* A guidance of registration application for imported biological products.
* A guidance of registration application for imported natural medicines and
traditional Chinese medicines.
* The significant suggestions for overseas pharmaceutical manufacturers and
producers looking to achieve a successful application for their 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 Chinese Good
Manufacturing Practice for 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.

For more information visit
http://www.researchandmarkets.com/research/6142d2/china_pharmaceutic

Research and Markets
Laura Wood
Senior Manager
press@researchandmarkets.com
Fax from USA: 646-607-1907
Fax from rest of the world: +353-1-481-1716

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