On June 27, 2019, Health Canada published Drug and medical device highlights 2018: Helping you maintain and improve your health, an annual highlights report for 2018. The report provides information regarding Health Canada drug (human or veterinary use) and medical device approvals, as well as published safety issues in 2018. In summary, in 2018, Health Canada approved 78 new drugs for human use (40 involving new active substances), 135 new generic drugs, and 4 biosimilars.
Moreover, the Therapeutic Products Directorate (TPD) and the Biologics and Genetic Therapies Directorate (BGTD) released their Drug Submission Performance Annual Reports for the 2018-2019 Fiscal Year, which include information and statistics relating to drug submission review activity from April 1, 2018 to March 31, 2019.
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Update on biosimilars in Canada – March 2024
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Federal Court of Appeal dismisses appeal of SPRAVATO “innovative drug” decision
On November 10, 2021, the Minister of Health refused to reassess its decision that Janssen’s esketamine hydrochloride product (SPRAVATO) was not an “innovative drug” and therefore not entitled to data...Read More