Guidance document for submitting risk management plans

Health Canada has published a new guidance document on the submission of Risk Management Plans (RMPs), which will come into effect on 1 July 2025. This update reinforces the importance of continuous surveillance and risk management throughout the lifecycle of medicines, aligning with international best practices and ensuring greater safety for patients.

Risk Management Plans are essential tools for identifying, characterising and minimising the risks of medicines. The new document reinforces the need for additional pharmacovigilance and risk minimisation measures in cases where there is significant uncertainty about the safety of a medicine or where there is potential for serious adverse effects.

Among the main changes is the incorporation of RMPs into Canadian regulations by April 2027, making the submission of these plans mandatory in certain circumstances, such as for new medicines, biosimilars and when there are emerging risks. In addition, a standardised format for the submission of documents has been established, ensuring greater transparency and efficiency in the regulatory process.

The new guidance represents an important step forward for pharmaceutical manufacturers wishing to operate in the Canadian market.

Access the full document below.