Started on March 26, 2015, and available through May 25th, 2015, Health Canada is conducting a “Needs-based Assessment” to evaluate end users’ transparency needs. The results of this consultation will be used to modify the way information is disseminated to stakeholders, and for the development of new regulations. To access the online questionnaire (answering it should take only 10 or 15 minutes) please click here.
The passage of Bill C-17 (“Vanessa’s Law” or “Protecting Canadians from Unsafe Drugs Act”) was announced by Health Canada in November. The new legislation introduces important safety improvements and transparency measures to Canada’s Food and Drugs Act, strengthening the regulation of therapeutic products, improving adverse event reporting, and allowing Health Canada to act quickly when a serious health risk is identified. “Vanessa’s Law,” will affect Canadian clinical trial requirements. The changes include a mandatory clinical trial registration initiative to ensure public disclosure of information by sponsors concerning clinical trials, and the disclosure of summary results.
Click here for more information on regulatory transparency and openness