Improving Access to Clinical DataPublished on May 27, 2019
Author: Karen Zhou
Health Canada has published final regulations that allow for the public release of clinical data on drugs and medical devices. Typically, clinical information in regulatory submissions has been treated as confidential business information (CBI), and in the absence of a formal policy on the identification of CBI, the established practice was not to release these data. To respond to Canadians’ concerns surrounding regulatory reviews and lack of information to help them form independent analyses of the evidence, Health Canada recognizes that increasing access to clinical data will enable the public to make informed decisions about their health. Improving access to clinical data is in line with the transparency initiatives introduced by Vanessa’s Law. Furthermore, the Medical Device Action Plan introduced in December 2018 also includes greater accessibility to clinical data as a key milestone in 2019.
Clinical information is available via the clinical information portal. While drug clinical data will be posted after the regulations came into force on March 29, proactive disclosure of device data will start in 2021. This is to allow Health Canada to coincide with the EU, which has also taken measures to increase transparency of clinical data for medical devices. For drugs and devices currently on the market, Health Canada will make this information available upon request and add this information to the portal.
The new regulations are published in the Canada Gazette Part II at the following links:
1. Regulations Amending the Food and Drug Regulations (Public Release of Clinical Information): SOR/2019-62
Amendments to the Food and Drug Regulations are applicable to New Drug Submissions (NDS), Extraordinary Use New Drug Submissions (EUNDS), Supplemental New Drug Submissions (SNDS), Supplemental Extraordinary Use New Drug Submissions (SEUNDS), Abbreviated New Drug Submissions (ANDS), Supplemental Abbreviated New Drug Submissions (SANDS), Abbreviated Extraordinary Use New Drug Submissions (AEUNDS), and Supplemental Abbreviated Extraordinary Use New Drug Submissions (SEUANDS). Amendments specify the type of information in any of these drug submissions that will no longer be considered CBI following a final regulatory decision.
2. Regulations Amending the Medical Devices Regulations (Public Release of Clinical Information): SOR/2019-63
Amendments to the Medical Devices Regulations specify the type of information on Class III and Class IV applications that will no longer be protected as CBI following a final regulatory decision. This information includes data supporting clinical trials or investigational testing in humans.
1. Health Canada finalizes regulations to provide public access to clinical information on drugs and medical devices https://www.canada.ca/en/health-canada/news/2019/03/health-canada-finalizes-regulations-to-provide-public-access-to-clinical-information-on-drugs-and-medical-devices.html
2. Health Canada’s Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/medical-devices-action-plan.html
Pragmatic Clinical Trials: Testing Treatments in the Real-World
What is a Pragmatic Clinical Trial? Clinical trials can be designed to be either pragmatic or explanatory. Explanatory trials are designed to find out whether a treatment...
The FDA Announces Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use – June 28, 2022
The FDA is announcing the availability of the proposed rule Nonprescription Drug Product with an Additional Condition for Nonprescription Use (Docket No. FDA-2021-N-0862)....