How are drugs approved?


Ontario Ministry of Health and Long-Term Care

The ministry provides drug coverage for more than 4,400 drug products. In most cases, these drugs must all be approved first by Health Canada and for brand name drugs either:

OR

One more step remains before a new brand name drug may be funded through Ontario’s public drug programs.  In most cases, the drug manufacturer must apply to the Ontario Ministry of Health and Long-Term Care.

How the ministry approves new brand name drugs

  1. Ontario’s expert advisory committee reviews the drug manufacturer’s submission. The committee looks at:
    • the clinical evidence to support its use
    • patient comments provided through a patient submission
    • the impact on health services compared to other available treatments. 
  2. The committee then recommends whether or not the drug product should be offered through either:
  3. The Executive Officer of the Ontario Public Drug Programs makes final drug funding decisions.  In general, the following factors are taken into consideration:
    • the committee’s recommendation
    • Advice from other advisory bodies, e.g. Citizen’s Council
    • Patient and societal impact, public interest
    • Product listing agreements with manufacturers
    • Drug program budgets
    • Other factors, e.g. government priorities

    Learn more about Ontario’s drug programs

How the ministry approves new generic drugs

Generic drugs must all be approved first by Health Canada

Since 2005, the Ministry has harmonized its generic drug submission review process with that of Health Canada, such that 90 to 95 percent of submissions for generic drug products no longer require scientific review by the ministry’s expert advisory committee. Submissions for these generic drug products are still required to meet the submission requirements, before a final decision is made for each product for designation of interchangeability on the Formulary.

For the remaining generic submissions that are still required to be reviewed by the ministry’s expert advisory committee, they will follow the normal review process for scientific evaluation. The ministry’s expert advisory committee will then make a recommendation on whether or not the drug product should be designated as interchangeable.  The ministry’s expert advisory committee’s recommendation will be taken under consideration before a final decision is made.

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