Canada ranks ninth in the world in value for generic drugs and has reached $5.8bn in sales as of today in 2022. To make effective, safe, and affordable drugs readily available to patients in the country, Health Canada – Canada’s Health Authority, is taking initiatives to improve the accessibility of generic products. For marketing, the generic version of a drug previously authorized by the Minister of Health, a drug manufacturer must provide documents stating that the generic drug is ‘pharmaceutically bioequivalent' to the Canadian Reference Product (CRP) via the Abbreviated New Drug Submission (ANDS).
Over the years, an identical medicinal ingredient has been a significant criterion for a drug to be of 'pharmaceutical bioequivalence' by Health Canada to approve it as a generic drug. However, Health Canada now considers ANDS eligibility by assessing if the drug is an ‘identical therapeutically active component.’ This means that the generic drugs which are hydrates or solvates of a CRP can now qualify for approval through the ANDS pathway. The sponsor should consult with Health Canada in advance to understand the list of documents required before filing the generic drug submissions.
The Abbreviated New Drug Submission (ANDS) Pathway
The draft regulation set forward by Health Canada helps the applicants understand the disparity between the medicinal ingredients in a generic drug product in comparison to the CRP. The drug manufacturers must submit the ANDS of their drug. The filed ANDS should state evidence that proves that the generic drug is of pharmaceutical equivalence with the CRP. The Minister of Health can ask the drug manufacturers to provide additional information about the generic drug concerning its safety and efficacy whenever there is a significant difference between a generic drug product and the corresponding CRP.
The applicants should comply with the following criteria put forward by the Food and Drug Regulations (FDR) before filing an ANDS:
- The new drug is pharmaceutically equivalent to the CRP
- The new dug is bioequivalent with the CRP
- The route of administration of the new drug and the CRP is similar
- The use of the new drug and the CRP is similar
Post the approval from Health Canada on these submissions, the drug manufacturers will receive a Notice of Compliance (NOC).
Benefits of the ANDS Pathway – A Win-win Situation
When a drug manufacturer receives a NOC from Health Canada, it is a clear declaration of equivalence. The ANDS pathway benefits the applicants by providing:
- Approval of generic drugs that allow the patient to access treatment options that are safe and effective, yet affordable.
- Eligibility for small businesses to apply for filing the ANDS for their drugs.
- Relaxing regulations around solvates, polymorphic forms, and salt forms that are different from the CRP.
Certain drugs that are not chemically identical in comparison to the CRP are not eligible for assessment in the ANDS pathway. Such differences include different complexes, clathrates, esters, and an enantiomer or mixtures of enantiomers.
Health Canada is optimistic about this initiative and expects four (04) to five (05) more submissions through the ANDS pathway as compared to the NDS pathway.
The market opportunity for generic drugs in Canada is extensive, and it is forecasted to grow by 2.3% in 2022. It presents Canadian-based, international pharmaceutical enterprises and smaller companies with a scope to expand their generic drug business in Canada.
To comply with the regulations drafted by Health Canada, one needs a proper ANDS submission that facilitates the approval process of generic drugs and hence hastens their time-to-market. A Regulatory specialist well equipped with the requirements of Health Canada ANDS submissions can help you deal with critical challenges such as identifying gaps and speeding the approval process. Consider Freyr as your Regulatory partner and benefit from our expertise in ANDS.