Piribo: Importing drugs to China. Make sure the authorities agree.

In China, like in other Western countries, the pharmaceutical authority, the China State Food and Drug Administration (hereafter called SFDA) requires applicants to submit complicated and reliable materials for application of drug registration. The SFDA stipulated the classification of drug registration in order to administer the application for drug registration process. At the same time, the SFDA collected the materials for application for drug registration into four categories and 32 items in accordance with various drug categories. When an application for drug registration is filed, the SFDA will request the applicant to not only submit designated material items in accordance with the prescribed category of drug, but also conduct the clinical trials as required for that drug category.

This is the second guidebook of the China Pharmaceutical Guidebook Series. It will provide a detailed introduction of SFDA's requirements for materials and clinical trials of application and approval for imported chemical drug registration, including radioactive pharmaceuticals.

“A Guidebook of Registration Application for Imported Chemical Drugs” is priced at £430 and is available in PDF format for immediate delivery from Piribo. For more information, go to: http://www.piribo.com/search/results.html?k=ACC005&x=0&y=0

About Piribo.
Piribo is a UK-based independent online store supplying business information on the pharmaceutical and biotechnology industries. The website now carries over 3,500 English language titles including, market reports, studies and books and is the UK’s largest online biopharma information store. Subscribers receive a free monthly newsletter and email alerts on new titles in their areas of interest. The company was established in 2004.