After several attempts at a major modernization via the Food and Drugs Act, it was decided in Health Canada to use the regulatory pathway to bring the regulations up to date without modifying the Food and Drugs Act itself. To that end, a new set of regulations for orphan drugs are being drafted. The approach that is used is novel, different, and unique as the regulatory framework; the needed guideline and the operational elements are being developed simultaneously and are informed by each other. In addition, the regulations will be a complete self-standing set which is intended to be a model for drug life cycle management. Health Canada has also adopted a number of postmarket ICH guidelines. Regulatory amendments are being drafted to allow Health Canada to request safety information on an ongoing basis from sponsors. In addition, in order to harmonize requirements, Health Canada has decided to consider the new PBRER as the format and content sufficient to fulfill Canadian requirements.

This session will also provide an overview of new developments on the clinical trial front with new directives, internationally, as well as the intended establishment of educational networks and networks of excellence that will facilitate global drug development.