SFDA issues Requirements on Application Dossiers in CTD Format for Pharmaceutical Products

In order to improve the quality and level of drug research and development of China and to be in line with international practice, the State Food and Drug Administration (SFDA) formulated the Requirements on Application Dossiers in CTD Format for Pharmaceutical Products on the basis of the Common Technical Document (CTD) of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical for Human Use (ICH) in combination with the actual situation of drug research and development of China and issued the Requirements on September 25, 2010.

Source: web of SFDA