Updated Notice: Interim Policy on Health Canada's Interpretation of Medicinal Ingredient and Assessment of Identical Medicinal Ingredient
October 5, 2017
Our file number: 17-111060-76
This Notice serves to inform sponsors of drug submissions pursuant to Division C.08.002.1 of the Food and Drug Regulations [that is an abbreviated new drug submission (ANDS)] of changes in Health Canada’s current interpretation of “identical medicinal ingredient”. Health Canada’s 2003 Policy on this issue states that different salts of the same therapeutic moiety are considered non-identical. However, to reflect evolving science and regulatory decision-making, the department is expanding the spectrum of applications that may be acceptable as an ANDS and for which a declaration of equivalence may be issued. This may include circumstances where equivalence is established between a generic product and a Canadian Reference Product (CRP) containing active substances that differ in physicochemical form (e.g., salt form) provided that the therapeutic moieties are the same and the safety and effectiveness between the two products is expected to be equivalent.
Health Canada is currently consulting on a Notice of Intent (NOI) that proposes possible changes to the Food and Drug Regulations with respect to the establishment of pharmaceutical equivalence between a proposed generic drug product and the CRP. Given the ongoing consultative process and above-noted changes, feedback on this updated notice is welcomed as part of the NOI consultation.
The changes do not apply to biological or radiopharmaceutical products, or to medicinal ingredients which do not possess a unique chemical structure (e.g., polymers with varying molecular weights).
Moreover, under an interim policy published in 2015, which followed the Federal Court decision (Justice Kane, 2013 FC 1217), Health Canada interprets “medicinal ingredient” as stated in the Food and Drug Regulations to mean the Active Pharmaceutical Ingredient (API) used as the raw material (input stage) in the manufacture of the finished dosage form (FDF).
Where the two medicinal ingredients are the same at both the input stage and in the FDF, an ANDS is the appropriate route. Health Canada also considers the following scenarios in determining whether the two medicinal ingredients are “identical”, such that an ANDS may be the appropriate route for assessment and whether additional data is required to support the ANDS:
- If the same medicinal ingredients at the input stage diverge into different physicochemical forms in the FDF (and the therapeutic moieties are the same), additional safety, effectiveness and quality data may be required.
- If the medicinal ingredients are different physicochemical forms at the input stage but nonetheless converge into the same physicochemical form in the FDF, the medicinal ingredients will be considered "identical", and additional safety, effectiveness and quality data will not be required.
- If the medicinal ingredients are different physicochemical forms at the input stage and remain different physicochemical forms in the FDF (and the therapeutic moieties are the same), additional safety, effectiveness and quality data may be required.
This issue will be further developed within a larger policy framework, at which time a new guidance document in line with potential amendments to the Food and Drug Regulations will be published to replace both the 2003 Policy Interpretation of 'Identical Medicinal Ingredient' and this 2017 Interim Policy.
The Patented Medicines (Notice of Compliance) Regulations continue to apply where a comparison or reference is made to a drug found on the Patent Register, regardless of the question of equivalence. The application is not dependent on the determination of pharmaceutical equivalence. In addition, the established meaning of "claim for the medicinal ingredient" continues to apply to the listing of patents on the Patent Register in accordance with section 4 of the Patented Medicines (Notice of Compliance) Regulations. Similarly, there is no impact on the application of the data protection provisions in section C.08.004.1 of the Food and Drug Regulations.
Submission sponsors are advised to discuss with Health Canada, in advance, when the "identicality" of two medicinal ingredients is in doubt for the purposes of establishing pharmaceutical equivalence.
For questions on the interpretation of medicinal ingredient or equivalence, please contact:
- Bureau of Pharmaceutical Sciences
- Therapeutic Products Directorate
- Health Canada
- Finance Building
- Address Locator 0202A2
- Ottawa, Ontario
- Telephone: 613-941-3184
- Facsimile: 613-957-3989
For questions related to patent listings or data protection, please contact the Office of Patented Medicines and Liaison at the Office of Submissions and Intellectual Property via email to email@example.com.
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