An amendment to the Food and Drug Regulations has been proposed that would apply to drugs regulated solely under Part C, Division 1 (i.e., drugs that have been sold in Canada for a sufficient time and in sufficient quantity to establish safety and effectiveness -- "Division 1 drugs"). The proposed amendment would require: (i) the submission of a quantitative list of all non-medicinal ingredients ("NMIs") present in a drug as part of a DIN application; (ii) that sponsors with Division 1 drugs authorized for sale in Canada submit their full quantitative list of NMIs to Health Canada within one year of the registration of the proposed amendment; and (iii) the submission of any changes to the NMI formulation of a Division 1 drug to Health Canada within 30 days of the change. NMIs contribute to the characteristics of a final drug product (e.g., palatability, drug release, etc.) and have been associated with adverse reactions and toxic effects.

At present, applications for Division 1 drugs are not required to include information on the NMIs present in the drug product formulation. Further, there is no requirement for manufacturers to inform Health Canada of any subsequent change to the NMIs in a Division 1 drug product once it is on the market. Thus, should a specific NMI pose a health risk, Health Canada may be limited in its ability to develop risk management strategies due to limitations in identifying all of the drugs on the market containing the NMI in question. A requirement to provide quantitative NMI information would allow Health Canada to (a) consider the risks associated with the NMIs present in a drug product formulation at the pre-market stage; and (b) enhance risk management activities in the event that NMI-related issues arise post-market. Manufacturers should note that the identification of a novel NMI may result in the reclassification of the drug from Division 1 to Division 8 (i.e., new drugs), as Health Canada considers the risk associated with novel NMIs to be less well characterized than commonly used NMIs.

Interested stakeholders have until December 22, 2011 to make representations concerning the proposed amendment.

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