Guidance document for submitting risk management plans

Health Canada has announced new guidance for Risk Management Plans (RMPs), reinforcing the need for pharmacovigilance and risk minimization throughout the life cycle of medicines. As of April 2027, the submission of RMPs will be mandatory in certain circumstances, such as for new drugs, biosimilars and cases of emerging risks. This update harmonizes Canadian regulations with international standards, ensuring greater safety for patients and transparency in the regulatory process. Manufacturers wishing to market products on the Canadian market must adapt to these new requirements.