Guidelines on Medicines Evaluation and Registration

This guideline provides guidance for applicants preparing a Common Technical Document for the Registration of Medicines for Human Use (CTD) for submission to the Pharmacy and Poisons Board (PPB). The document describes how to organize applications based on the Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines on the CTD. According to the CTD format, each application is a collection of documents, grouped into 5 modules. Module 1 prescribes Administrative Information and Prescribing Information requirements which are region-specific. The Summaries, Quality, Non-clinical, and Clinical modules have been described in Modules 2 to 5, respectively. Applicants should not modify the overall organization of the CTD.

If not contained in the bulk of the documentation, any additional data should be included as addenda to the relevant part, together with the additional expert comments that may be provided as a supplement to, or incorporated into, the relevant summary, overall summary, or overview. Information in these Modules should be present in relevant sections.