ANDS is Canada’s preferred generics gateway
Canada ranked tenth in the world in terms of generic medicine value, with sales of $5.8 billion in 2022. Health Canada – Canada’s Health Authority – is working to make generic pharmaceuticals more accessible to patients across the country in order to make them more effective, safe, and economical. A drug producer must submit papers indicating that the generic version of a drug previously approved by the Minister of Health is ‘pharmaceutically bioequivalent’ to the Canadian Reference Product (CRP) via the Abbreviated New Drug Submission (ANDS).
An same medicinal ingredient has long been a key condition for a medicine’s ‘pharmaceutical bioequivalence’ and approval as a generic drug by Health Canada. Health Canada currently evaluates ANDS eligibility by determining if the medicine is a “identical therapeutically active component.” This means that generic medications that are CRP hydrates or solvates can now be approved through the ANDS process. Before filing generic medicine submissions, the sponsor should engage with Health Canada to understand the list of papers required.
The ANDS (Abbreviated New Drug Submission) Process
The proposed regulation by Health Canada clarifies the differences between the medicinal components in a generic medicine product and the CRP. The ANDS of a medicine must be submitted by the manufacturer. Evidence proving that the generic medicine is pharmaceutically equivalent to the CRP should be included in the ANDS. When there is a considerable difference between a generic drug product and the relevant CRP, the Minister of Health can order drug producers to give more information about the generic medicine’s safety and efficacy.
Before filing an ANDS, applicants must meet the following conditions set forth by the Food and Drug Regulations (FDR):
• The new medication is chemically identical to CRP.
• The new dug is biologically identical to CRP.
• The new drug’s and CRP’s administration routes are comparable.
• The new medication and CRP have comparable uses.
The medicine makers will get a Notice of Compliance once Health Canada has approved these submissions (NOC).
ANDS Pathway Benefits – A Win-Win Situation
A NOC from Health Canada is an unambiguous certification of equivalency for a medicine producer. The ANDS pathway provides the following benefits to applicants:
• Approval of generic medications, which give patients access to safe and effective treatment options that are also affordable.
• Small firms are eligible to apply for filing the ANDS for their medications.
• Relaxing laws governing solvates, polymorphic forms, and salt forms other than the CRP.
Certain medications that are not chemically similar to the CRP are not eligible for the ANDS route evaluation. Different complexes, clathrates, esters, and an enantiomer or combinations of enantiomers are examples of such distinctions.
Health Canada is bullish about this endeavour, anticipating four to five times as many submissions through the ANDS pipeline as the NDS pathway.
In 2022, the market for generic pharmaceuticals in Canada is expected to expand by 2.3 percent. It provides opportunities for Canadian-based foreign pharmaceutical companies and smaller companies to expand their generic medicine business in Canada.
To comply with Health Canada’s requirements, a correct ANDS submission is required, which speeds up the approval process for generic pharmaceuticals and thereby reduces their time to market. A regulatory expert familiar with the requirements of Health Canada ANDS submissions can assist you in overcoming important hurdles like finding gaps and expediting the approval process. Consider Freyr as a regulatory partner and take advantage of our ANDS experience.
Category: Pharmaceuticals, Regulatory Affairs.
Key Words: ANDS Regulatory Framework, Health Canada, Drug Submission.
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