Introduction: The FDA recently announced a proposal to change the current regulations for Investigational New Drug (IND) applications. The proposal includes two exemptions from IND... Read more
What is an Adverse Reaction Reporting?
Adverse Reaction reporting is mandatory in Canada and must be filed with Health Canada within 15 calendar days of receiving or becoming aware of the incident. These can be submitted through fax, mail or by completing an online form. The success of Health Canada’s Adverse Reaction reporting system depends majorly on the completeness, quality, correctness and timelessness of the information submitted. Adverse drug reaction reporting may cause changes in decisions on regulatory actions such as withdrawal of a product from the Canadian market, health product effectiveness and imparting knowledge about health product safety that benefits all Canadians.