Results of “Good Clinical Practices” Health Canada inspections now posted on public database
As part of Health Canada’s (HC) commitment to regulatory transparency, information on all clinical trial inspections performed in Canada will be published by December 11, 2015 in Health Canada’s existing Drug and Health Product Inspections Database.
The database will include three main elements:
Lists of Inspections
- A list of all Good Clinical Practices inspections conducted since January 1, 2012 to present will be included within the database. The list includes general information such as sponsor name, date of inspection and rating.
Initial Inspection Deficiencies
- The Initial Inspection Deficiencies provide a preliminary overview of the inspection findings and are published within 3 days of the inspection. Initial Inspection Deficiencies will be published for all inspections which occur after the launch of Good Clinical Practice inspections in the database.
Inspection Report Cards: The Inspection Report Cards offer plain language summaries of inspections. They are published within 30 days of the inspection and will include the following:
- information identifying the sponsor and drug name
- date of the inspection
- trial phase
- region of the site inspected
- inspection type
- inspection rating
- observations made by the inspector
- measures taken by Health Canada.
Inspection Report Cards will be published for all inspections conducted on or after September 15, 2015.
Inspection Report Cards will be published for any inspection conducted between January 1, 2012 and September 15, 2015 that received a non-compliant rating.
If you have inquiries about this initiative, please contact Health Canada at the following e-mail address: firstname.lastname@example.org
Further information about Health Canada’s Regulatory Transparency and Openness Framework can be found here.