Canada aims to make safety labeling changes to generic drugs timely with new pilot
This article was originally published in SRA
Health Canada has launched a new pilot program to ensure generic drug makers are kept abreast of safety-related labeling changes to product monographs of reference branded drugs1,2. Providing generic companies with this information, it hopes, will help facilitate timely corresponding updates to generic product monographs.
You may also be interested in...
The International Pharmaceutical Regulators Programme has documented various approaches currently being used for the clinical comparability of biosimilar monoclonal antibodies in different jurisdictions.
Remote inspections are here to stay, and global regulators are aligning efforts to develop consensus on how these should be conducted.
Device companies operating in Canada are being advised to review their internal procedures in anticipation of new postmarket requirements that come into force this year.