Regulation - LGIC

Optimizing Appropriate Access to Unlisted Drugs and Further Streamlining Submission Requirements for Generic Drugs (2016)

Regulation Number(s):
Instrument Type:
Regulation - LGIC
Bill or Act:
Ontario Drug Benefit Act (ODBA) and Drug Interchangeability and Dispensing Fee Act (DIDFA)
Summary of Decision:
Effective October 1, 2016, the government amended Ontario Regulation 201/96 made under the Ontario Drug Benefit Act.

The regulatory amendments will improve access to unlisted, non-Formulary drug products by permitting the Executive Officer to consider drug products that have restricted access through the Exceptional Access Program for listing on the Formulary. Additionally, the amendments allow generic drug products with no comparable reference product of the same strength (known as "generic line extensions") to be considered for Formulary listing.

The regulatory amendments:

1) establish criteria that would exempt manufacturers of certain drug products from specific submission requirements and allowing for an abbreviated submission.

2) allow generic line extensions to submit alternative evidence regarding product safety and efficacy.

Effective October 1, 2016, the government amended Regulation 935 made under the Drug Interchangeability and Dispensing Fee Act (DIDFA).

These regulatory amendments allow the ministry to improve access to generic drug products by making more generic drugs eligible for the faster, streamlined drug submission process.

The regulatory amendments:
1) Add a definition of "generic line extension"

2) Exempt generic products with a Declaration of Equivalence from Health Canada from certain submission requirements under the DIDFA

3) Exempt generic line extensions approved for listing under the Ontario Drug Benefit Act (ODBA) from having to make a submission under the DIDFA.
Further Information:
Proposal Number:
Posting Date:
June 1, 2016
Summary of Proposal:

1. Allow Ministry to transition unlisted, non-Formulary drugs from EAP to the Formulary:

• Current regulations prevent the ministry from moving EAP products to the Formulary without a submission from the manufacturer.

• This restrictive access through EAP does not make sense to clinicians or the public for some drug products such as old drug products with established safety and effectiveness, products requiring urgent access, or drugs that may be less costly than newer listed alternatives.

• The proposed amendments would authorize the Executive Officer (EO) of Ontario Public Drug Programs to list a drug on the Formulary without a full submission from a manufacturer if the EO had sufficient evidence that the product was therapeutically effective and had a low risk of inappropriate utilization if funded outside the EAP.


1. Accept all of Health Canada's (HC) Declaration of Equivalence (DOE) for generic products:

• When Health Canada reviews generic drugs and finds them to be equivalent (i.e. as safe and effective) to the brand product, it issues a DOE. The ministry has streamlined the majority of generic products with DOEs (approximately 95%). There are some with DOEs that are still reviewed under the longer, non-streamlined review process (approx. 4 months before listing) which require review by the ministry's expert advisory committee, the Committee to Evaluate Drugs (CED). These products were not captured by previous streamlining changes.

• The proposed amendments to Regulation 935 made under the DIDFA would allow the ministry to accept HC's DOE and allow more generic drugs to be eligible for the faster, streamlined review process (approx. 2 months before listing).

2. Allow generic line extension products to be considered for listing without product-specific clinical data:

• Currently, to be considered for listing under ODB, generic products must show that they are equivalent to their brand reference product in the same strength that is already considered to be clinically effective.

• In some cases, generic manufacturers cannot provide this information because there is no brand product of equal strength available on the market. These products are known as "generic line extensions". The proposed amendments would allow the ministry to accept other information to show that the generic line extension is clinically effective (e.g. bioequivalence data and formulation proportionality data).
Contact Address:
Executive Officer, Ontario Public Drug Programs
Ministry of Health and Long-Term Care
80 Grosvenor St., 9th Floor
Hepburn Block, Queen's Park
Toronto, ON M7A 1R3
Fax: 416-325-6647
Effective Date:
October 1, 2016