Over the next three years, Health Canada says it will enhance its early warning systems on drug and device safety issues, particularly those in other countries, further communicate explanations for regulatory decisions and update and expand guidance on regulatory requirements.
The plan, laid out by the agency this week, also points to the need for more inspections of pharmaceuticals, medical devices and other health product businesses that it regulates.
Building off of its regularly updated inspection tracker and plans to add more information to its drug and health product register, the agency noted in another recent report that from 1 April 2014 to 31 March 2015, 121 of its inspectors conducted 1,184 on-site inspections in Canada, while eight on-site foreign inspections were conducted and another 1,563 paper reviews were performed of inspections conducted by foreign regulators.
Canadian inspectors conducted 442 domestic good manufacturing practices (GMP) inspections in 2014-2015, and made 3,096 observations, most of which were cited against requirements for quality control and manufacturing control. Of these observations, 17 were critical, 1,500 were major and 1,579 were minor.
“In the next few years, it is expected that the total number of foreign on-site inspections will multiply,” Health Canada said, noting that it will work with other international regulators to plan using site risk profiles and conduct foreign on-site inspections of the highest-risk facilities.
In particular, Health Canada will focus continually on data integrity signal detection and analysis after issues were discovered in this area over the last year.
Call for Feedback
As part of this transparency push, and following the launch of its Regulatory Transparency and Openness Framework, Health Canada is seeking feedback from industry and other stakeholders on the next steps regarding several of its initiatives, including:
And unlike the US Food and Drug Administration, Health Canada has vowed to release negative decisions made after 1 April 2016 for new drug submissions, supplemental new drug submissions for new uses and new class IV medical device applications.
The agency has also said it will make more scientific information publicly available on a pro-active basis through mechanisms such as the government's Open Data Portal.
In addition, Health Canada plans for the first time to make inspection information available about pesticides and to post quarterly inspection reports for medical marijuana.
Regulatory Transparency and Openness Framework and Action Plan 2015-2018
Consultation on Health Product Transparency Initiatives
Inspectorate Program - Annual Inspection Summary Report 2014-2015