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How Drugs Are Approved : Review Process

New Drug Funding Program for Cancer Care

The Ontario Drug Benefit Program and Cancer Care Ontario have developed a common submission and evaluation process for all cancer-related drugs for consideration under the New Drug Funding Program (NDFP) for cancer care. Find out more information about the NDFP and the drugs that are covered, by visiting the Cancer Care Ontario website.

Exceptional Access

On a case-by-case basis, the Exceptional Access program provides ODB-eligible individuals with coverage for drugs that are not listed in the Formulary/CDI but approved for sale in Canada (by the federal government), Exceptional Access is requested by an Ontario-licensed physician and reviewed by the CED.

Generic Drugs

Generic drugs have the same active ingredient as the brand name products. Because they have the same active ingredient, generic drugs behave in the same way as brand name equivalents, and can therefore be substituted, or become "interchangeable" with the brand name drug. Generic drugs are the same quality and efficacy as brand name drugs.

Generic drugs must meet the same scientific norms and standards as brand name drugs. These standards are set by Health Canada. As part of its approval process, Health Canada declares generic drugs as equivalent to comparator brand name products.

Streamlined Submissions

The Ministry has harmonized its generic drug submission review process with that of Health Canada, such that 95% of submissions for generic drugs no longer require review by the CED. Submissions for these products are still required to meet the specific submission requirements under the Drug Interchangeability and Dispensing Fee Act (DIDFA), as defined in Regulation 935, prior to being forwarded to the Executive Officer for approval.

Non-Streamlined Submissions

All "non-streamlined submissions" are reviewed by the CED, similar to the process for "new drug" reviews.

See also :

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