The Ontario Ministry of Health has recently updated the Ontario Guidelines for Drug Submission and Evaluation (Guidelines). In an effort to reduce complexity and simplify their policy document, specific guidelines aiming to address individual product types are now available on the Ontario Ministry of Health website.
Summary of changes
- Incorporation and consolidation of regulatory and policy changes since last issuance of the Guidelines in September 2016
- Specific guidelines for individual product types provided as 11 separate documents
- Approximately 12 pages per guideline
- Simpler navigation/readability with relevant checklists and templates linked within each respective guideline
- Streamlined submission requirements for various submission types
- 30% reduction in total number of requirements
Summary Table: Ontario Submission Requirement Changes (select guidelines)
These changes are effective immediately and are posted on the ministry’s website.
Please contact Ara Salazar, Director, Market Access at firstname.lastname@example.org for any questions or further information.