Canada Finalizes Recommendations on 3rd-Party Data in Drug Submissions

Sponsors seeking Canadian approval of new drugs or indications based on published literature or postmarketing data need to be able to prove that their drug is comparable to its reference product, regulators say.

The guidance applies specifically to companies submitting applications for new drugs or for new indications or formulations of approved drugs when it would be unethical and unnecessary to expose patients to trials because the drug’s clinical safety and efficacy is already well-documented.

In such cases, the sponsor could use published data on another drugmaker’s product — the reference product — to support the safe use of the drug it is seeking to market, Health Canada spokesman Patrick Gaebel tells IPRM.

This can be done by comparing the new drug’s pharmaceutical or bioavailability characteristics with those of the reference product, the guidance says. For a fairly simple drug dissolved in water, for example, comparative physicochemical data will be enough, according to final guidance on submissions that rely on third-party data.

Health Canada stresses that data from published pivotal clinical studies, such as a drug’s source, its formulation and method of preparation, reports of foreign regulatory reviews or approvals and periodic safety update reports on the reference product’s postmarket performance won’t suffice to prove a drug’s safety and efficacy.

Submissions also need:

  • A justification of the filing that explains why the sponsor didn’t submit a conventional application;
  • A complete chemistry and manufacturing package;
  • Comparative evidence proving the reference product is representative of the sponsor’s product;
  • Evidence of at least 10 years of foreign market experience with the same active ingredient or evidence that it is, or has been, marketed in Canada;
  • A systematic review of the methodology that the sponsor used in reviewing and choosing published literature;
  • Copies of all of those documents;
  • Complete and current evidence-based information for developing a Canadian product monograph;
  • A Canadian risk-management plan; and
  • A presubmission meeting with Health Canada to discuss the evidence required to support marketing of the drug.

Health Canada says it will review applications on a case-by-case basis.

Read the final guidance at — Lena Freund

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