Health Canada's stance on Pharmacogenomics

Pharmacogenomics is a scientific field that optimizes drug therapy based on an individual's genotype. Advances in this field enable personalized medicine for each patient, increasing treatment effectiveness while reducing the risk of side effects. Health Canada supports incorporating this into the drug development process, but its stance has some unique characteristics when compared to the US FDA and the European Medicines Agency (EMA).

"Health Canada, the federal regulatory authority that evaluates the safety, efficacy, and quality of health products available in Canada, recognizes that the application of pharmacogenomics (PGx) is increasingly becoming an integral part of the drug discovery and development processes" ( Health Canada )

Using Companion Diagnostics

Health Canada advises sponsors considering the use of pharmacogenomic tests (also known as companion diagnostics ) to assist in treatment selection, e.g. drug and dosage selection, if the test has not yet been approved. If so, we encourage you to apply for a medical device license during drug development . If you already have a license, you should include the name, description, and license number of your IVDD in your submission.

Health Canada processes

When submitting Pharmacogenomic data to the Clinical Trial Application (CTA) , Health Canada provides information related to the pharmacological or pharmacodynamic aspects, pharmacokinetics, and toxic effects of the drug and the product being investigated in the proposed clinical trial. support the use of or request the submission of relevant data. This means that any previous human clinical trial results supporting safety or efficacy must also be submitted to the CTA.

Comparison with FDA and EMA

Health Canada's approach differs from that of the US FDA and EMA. For example, the FDA and EMA do not require sponsors to submit any genetic data. However, Health Canada requires pharmacogenomic data to be submitted if it provides evidence of a drug's safety and/or clinical effectiveness. This has led Health Canada to request more data to prove the drug is safe and effective for its proposed indication.

Labeling and medical device licensing

Pharmacogenomic information may be used to determine whether efficacy or safety varies by patient genotype, when dosing needs to be considered in a particular patient, or when genetic testing is available (if available, to initiate treatment). should be included in the labeling of a drug or biologic if it helps to inform the prescriber whether prior testing is required or recommended).

Pharmacogenomics and Companion Diagnostics

In Canada, all devices intended for pharmacogenomic testing are classified as Class III medical devices and require a pre-market review and medical device license. An MDL application can be submitted at the same time as a drug for which it provides pharmacogenomic data.

Conclusion

Health Canada's stance on Pharmagenomics is focused on providing safer and more effective treatments for patients. Through the use of Companion Diagnostics , we have rigorous processes in place to ensure drug safety and effectiveness. This will ensure that Canada's drug development process will continue to play an important role in the advancement of personalized medicine.