Ontario Regulation 85/24, enacted under the Drug Interchangeability and Dispensing Fee Act, brings amendments to Regulation 935 of the Revised Regulations of Ontario, 1990, focusing on the interchangeability of drug products. The regulation aims to refine the criteria for establishing drug interchangeability, thereby improving the efficiency of the healthcare system in Ontario.

A significant change is evident in clause 6 (1) (h), which has been revoked and replaced with a new requirement. The revised clause mandates that comparative bioavailability studies on humans, comparative clinical studies on humans, or other in vivo studies must demonstrate the interchangeability of a product with the original or another listed interchangeable product. This revision highlights the importance of clinical evidence in determining drug interchangeability, ensuring that substituted products maintain similar efficacy and safety profiles as their original counterparts.

Additionally, subsection 6 (5) has been amended to clarify that the requirement for comparative studies does not apply to drug products that are pharmaceutically equivalent to the original product or another listed interchangeable product. To qualify for this exemption, the product must meet several criteria, including demonstrating the same physicochemical properties as the original or interchangeable products, maintaining identical dosage form, packaging format, and strength, and falling into specific categories of solutions. These categories include parenteral aqueous solutions or powders for reconstitution that can be administered via intravenous, intramuscular, subcutaneous, or intrathecal routes, as well as oral solutions, elixirs, syrups, or similar forms in the same concentration without ingredients that could affect the bioavailability of the active ingredient. The exemption also covers topical aqueous solutions for ophthalmic, otic, nasal, rectal, vaginal, or inhaled administration. These stipulations facilitate quicker access to alternative therapies by allowing certain formulations that are chemically and physically identical to their counterparts to be marketed as interchangeable without extensive clinical testing.

Another key addition is subsection 6 (5.1), which specifies that clause (1) (h) does not apply to products not classified as new drugs under the Food and Drug Regulations made under the Food and Drugs Act (Canada). The executive officer can determine interchangeability based on the product’s approval for sale in Canada by Health Canada and any other pertinent information available to them.

Lastly, paragraph 1 of subsection 6 (6) has been amended to require manufacturers to provide in vitro studies that satisfy the executive officer regarding the product’s interchangeability with the original or another listed interchangeable product.

By emphasizing the necessity for rigorous comparative studies and establishing clear exemptions for certain formulations, the regulation seeks to streamline the process of bringing interchangeable drug products to market.

Ontario (85/24) March 23, 2024