New Processes and Guidance Documents

A thorough impact analysis of the changes to be brought about by the progressive licensing model will involve identifying where new processes and guidance documents will be necessary. The consultations and development of these new processes and guidance document will require extensive work and hence require Health Canada to consider resource implications.

The implementation of a life-cycle approach to the regulation of drugs would require the enhancement of scientific and medical expertise within Health Canada. Potential features of the new regulatory framework--such as earlier consultation with industry prior to drug submissions, review of pharmacovigilance and risk management plans, and re-evaluation of drug information after a period of initial marketing--would require a significant investment in human resources. Investment is required to ensure that a critical mass of expertise will be established through recruitment and retention of skilled technical experts, and to ensure resource requirements are met.

Contact information for the Progressive Licensing Project.