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Ministry Status: Activation Status

Ontario Public Drug Programs

Glossary – F

This glossary provides brief explanations of terms used in the Ontario Public Drug Programs web pages. To access a term definition, select the appropriate letter from the alphabet below.

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
F/P/T Federal/Provincial/Territorial
FDA See Food and Drugs Act
FDA See Food and Drug Administration
First line, second line, third line A first-line therapy is the standard first treatment option for a specific medical condition and patient.

A second-line therapy is one a physician uses if first-line therapy was not successful or if the normal first option for treatment is not appropriate for that patient, because of his or her medical condition or allergies, for example.

Third-line therapy is used when first- or second-line therapy is not successful or is inappropriate.

First review

First Review refers to the first time the CED reviews and discusses a manufacturer’s submission.

Once a submission is determined to comply with Ontario’s regulations, its status is noted as complete and the submission is sent to one or more CED reviewers. CED members or reviewers drawn from a roster of external consultants review the submissions.

When the Ministry has received all reviews of a particular product, the submission is then scheduled as a First Review agenda item for the next available CED meeting. The submission is ranked in the meeting agenda according to the date the Ministry deemed it complete.

First review submissions, both single-source and multiple-source, are considered first on the CED meeting agenda. After the CED considers first-review submissions, it moves on to second-review submissions and finally items submitted for reconsideration. Within each category (first review, second review, reconsideration), submissions are ranked in the agenda according to the date each submission was deemed complete. Drug products designated for "rapid review" are given a preferred status. (See Rapid Review)

Food and Drug Administration The United States Food and Drug Administration
Food and Drugs Act Canada’s Food and Drugs Act.

Before drug products are authorized for sale in Canada, Health Canada reviews them to assess their safety, efficacy and quality. Drug products include prescription and non-prescription pharmaceuticals, disinfectants and sanitizers with disinfectant claims.

Prior to receiving market authorization, a manufacturer must present substantive scientific evidence of a product's safety, efficacy and quality, as the Food and Drugs Act and its regulations require.

When a product is offered for sale in Canada to treat or prevent diseases or symptoms, it is regulated as a drug under the Food and Drugs Act.

Formulary

A formulary is a list of drugs that are covered as benefits. Each drug plan determines its own list.

The Ontario Drug Benefit Formulary/Comparative Drug Index defines the benefits provided for eligible recipients of the Ontario Drug Benefit (ODB) program. The Formulary is developed in consultation with the ministry's external expert drug advisory committee, the CED. For many years, the Formulary has set the provincial standard for price, quality and interchangeability of drug products. For example, it serves as a guide to:

  • practitioners and pharmacists regarding drug products that are eligible for coverage under the ODB program.
  • professional committees in hospitals and institutions as they select drug products.
  • drug product interchangeability.
  • comparative pricing guide for drug products.

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