Health Canada’s Public Release of Drug, Device Clinical Data Picks Up Steam
Last March, amendments to Canada’s Food and Drug Regulations and the Medical Devices Regulations enabled the public release of clinical information submitted to Health Canada for new drug and device approvals.But in the first five months after the amendments took effect, just one clinical trial package for a new drug and one clinical trial package for a new device were published. In the last two months, however, Health Canada has published information on eight more drugs and three more Class III devices.
Although each of the drug packages of study documents is different, the disclosures generally include information on clinical efficacy, safety, pharmacology studies, population pharmacokinetics studies and other reports.
In July and August, Health Canada released information on AbbVie’s plaque psoriasis drug Skyrizi (risankizumab), Merck’s measles, mumps, rubella, and varicella vaccine ProQuad, Gilead’s HIV medicine Odefsey (emtricitabine, rilpivirine, and tenofovir alafenamide) and Sanofi and Regeneron’s skin cancer drug Libtayo (cemiplimab), among others.
On the device side, Health Canada has published information on Allergan’s Juvéderm Volbella with Lidocaine, Mona Lisa’s Mona Lisa 10 (CuT 380A QL) Intrauterine Device and Ethicon’s Gynecare Gynemesh PS.
In addition, information on 20 other drugs, including Seattle Genetics’ Adcetris (brentuximab vedotin), Bayer’s Vitrakvi (larotrectinib) and Amgen’s Evenity (romosozumab), as well as five other devices are coming.
“Clinical information from past drug submissions and medical device applications (which received a final regulatory decision prior to the coming into force of the regulations on March 20, 2019) may be requested through Health Canada's clinical information portal,” Health Canada added in March guidance on its public release of clinical information.
Health Canada Clinical Information on Drugs and Medical Devices