Proposed Amendments for Increased Transparency in Drug and Medical Device Clinical Information

by | Feb 14, 2018 | Canadian Regulatory, Medical Devices, OTC Drugs | 0 comments

In drug submissions and medical device applications, clinical information provided by the manufacturers is treated as confidential business information by Health Canada. However, since the development of Vanessa’s Law (Protecting Canadians from Unsafe Drugs Act) there have been calls for increased transparency within drugs and medical drugs. As a result, Health Canada had announced their intention to amend the Food and Drug Regulations as well as the Medical Devices Regulations to allow for public release of clinical information submitted to Health Canada by drug and medical device manufacturers.

This disclosure of confidential information to the public will allow health professionals and researchers to perform independent analyses of the published research findings, identifying or responding to possible risks of the health of Canadians as well as promoting greater confidence of the drug or medical device.

This amendment will mirror the European Medicines Agency and the U.S. Food and Drug Administration who have had clinical data transparency for over 10 years.

Manufacturer clinical information that will cease to be confidential once the amendment passes includes:

  • clinical summaries,
  • reports and supporting data of clinical trials submitted to Health Canada in support of a drug submission or,
  • reports and supporting data of clinical trials submitted in support of a Class III or Class IV medical device application.

Clinical information that is excluded from this amendment and will remain confidential include:

  • information that that manufacturer did not use in their drug or medical device submission,
  • information that describes the tests, methods or assays used in the clinical trials that are exclusive to the manufacturer.

These amendments will apply to drugs that are for human use only. Moreover, the proposal intends for the clinical information to becoming public information after the final regulatory decisions by Health Canada and will remain confidential during the regulatory review process.

Questions or concerns regarding their proposed amendments may be emailed to LRM_MLR_consultations@hc-sc.gc.ca and will be closed February 22, 2018.

For more information, please do not hesitate to contact Focal Point Research Inc.  We are leading Canadian regulatory and Health Canada consultants for  OTC Drugs and Medical Devices.