Release of the Regulatory Roadmap for Radiopharmaceutical (Schedule C) Drugs in Canada      

Health Canada is pleased to announce the release of the Regulatory Roadmap for Radiopharmaceutical (Schedule C) Drugs in Canada.

This roadmap is a new webpage that aims to inform regulated parties and interested stakeholders of the documents available on Canada.ca to guide them throughout the regulatory life cycle of a radiopharmaceutical drug.

ICH Overhauls 22-Year-Old Clinical Studies Guideline

For the first time in 22 years, the International Council on Harmonization (ICH) is almost completely overhauling the guideline ICH E8 — General Considerations for Clinical Studies, the international standard for designing and developing trials.

The major rewrite of the 1997 guideline, which is expected to go into effect in June 2020, would replace the development methodology section of the original document with five new sections that apply the quality-by-design method to trial development:

• Designing quality into clinical studies;
• Drug development planning;
• Design elements for clinical studies;
• Conduct and reporting; and
• Considerations in identifying critical-to-quality factors.

Health Canada released new guidance that the agency hopes will make it easier to study the off-label benefits of drugs in clinical trials.

Canadian regulations currently require any treatments purchased for clinical trials for their off-label properties to be designated “investigational drugs.” But Canadian officials worry that’s adding unnecessary hurdles that slow life-saving or life-changing research. Read More