Guidance for Application Materials/Booklets (Chemical)

Currently, drug registrations in China follow the Provisions for Drug Registration, Order No. 28, effective since 2007. This regulation provides clear definitions and dossier application requirements for various drug categories and classes in the acceptance, review, approval, and overall registration processes. The regulation also clarifies the requirements for source data review, criteria for on-site inspection and product quality inspection. Since 2005, the State Food and Drug Administration (SFDA) has promulgated a series of guidelines to ensure drug quality and standardize drug research and development processes. In addition, they also issued guidance for dossier summary preparations of chemical drugs, Provisions for Drug Insert Sheets and Labels and other regulations. In this chapter, we’ll use Class I chemical drug as an example to introduce the preparations for each of the 32 items/booklets in combination with the corresponding guidelines, as well as the comparisons with CTD contents.