(2010; 94 pages)
Objective of the guidelines:
This guideline presents a common format for the preparation of a well-structured application that will be submitted to Pharmacy and Poisons Board. This format for presentation of technical documentation will significantly reduce the time and resources needed to compile applications for registration of pharmaceuticals and will in future ease the preparation of electronic submissions. Evaluation of dossiers and communication with the applicants will be facilitated by a standard document of common elements. This revised guideline has been improved by giving more details on requirements for active pharmaceutical ingredients (APIs) as well as finished pharmaceutical products (FPPs). In addition, requirements on bioequivalence and bio-waver(s) have been updated in line with the current state of knowledge. The improvements in this guideline are based on the World Health Organization (WHO) Guidelines on Submission of Documentation for Prequalification of Multi-source Finished Pharmaceutical Products and the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for human use.
Scope of the guidelines:
This guideline primarily addresses the organisation of the information to be presented in registration applications for new pharmaceuticals (including biotechnology-derived products). This guideline is not intended to indicate what studies are required. It merely indicates an appropriate format for the data that have been acquired. Applicants should not modify the overall organisation of the document as outlined in the guideline. However, in the Nonclinical and Clinical Summaries, applicants can modify individual formats if needed to provide the best possible presentation of the technical information, in order to facilitate the understanding and evaluation of the results.