Canada makes drug and medical device clinical data public

14th March 2019 (Last Updated March 15th, 2019 11:20)

Health Canada has started making clinical information on drugs and medical devices available to public through its new Clinical Information Portal.

The move comes as the regulatory agency addresses the need for access to credible information for Canadians to make informed health decisions.

Clinical information is the data provided by companies at the time of requesting product authorisation. It includes findings from study reports and clinical trial results.

Initially, data provided by volunteer companies on certain products will be available on the Health Canada portal as of 13 March 2019.

The regulatory agency will publish final regulations for the public release of clinical information on 20 March. These regulations form part of the transparency measures under Vanessa’s Law that protects consumers from unsafe drugs.

After the regulations come into effects, Health Canada will release clinical information from drug submissions within 120 days after review of each filing.

Disclosure for medical devices will be commenced in 2021, coinciding with the European Union (EU) measures to improve transparency of clinical information on medical devices.

Upon request, Health Canada will add data of drugs and medical devices that are already on the market.

A statement from Health Canada read: “Canadians want greater access to credible information that will enable them to make well-informed decisions about their health and that of their families.

“Health Canada recognises that increasing access to clinical data on drugs and medical devices can have widespread benefits throughout the health care system and on the health outcomes of Canadians.”

The regulatory agency worked with academic researchers, health care professionals, patient groups and industry players to decide the type of information that can be released to the public.

It will consult manufacturers to remove confidential and personal information before sharing on the portal.