Notice: Guidance on the Clinical Assessment of Abuse Liability for Drugs with Central Nervous System Activity
July 4, 2019
Our reference number: 19-111910-93
Health Canada continues to support regulatory alignment with other respected regulatory authorities, where possible. By way of this Notice, please be advised that Health Canada is proposing the use of U.S. FDA guidance materials to guide regulatory considerations relating to study design and data requirements for the assessment of abuse liability of drugs with central nervous system activity.
Stakeholders are invited to consult the current U.S. FDA guidance on this topic for relevant information on Health Canada expectations for study design and data requirements. The FDA guidance "Assessment of Abuse Potential of Drugs (2017)" can be found on the FDA website.
It is understood that some references within FDA guidance may not be relevant to the Canadian context (e.g., references to U.S. laws or other guidance documents). In particular, on tamper resistance formulations, Health Canada has published its own guidance entitled Tamper-resistance Formulations of Opioid Drug Products.
Stakeholders are still invited to discuss data in support of their submission in advance of filing their submission(s) by requesting a pre-submission meeting. Additional process information can be found on the Health Canada website.
Additionally, it is proposed that the previous Health Canada Guidance Document - Clinical Assessment of Abuse Liability for Drugs with Central Nervous System Activity, published in 2007, will be removed from our website.
Should you have any concerns with the proposed approach, please direct any questions or comments by August 18, 2019 to:
Bureau of Cardiology, Allergy and Neurological Sciences
Therapeutic Products Directorate
Health Products and Food Branch
Health Canada
Address Locator: 3102C
Health Canada
Ottawa, Ontario
K1A 0K9
E-mail: bcans_enquiries@hc-sc.gc.ca
Telephone: 613-941-1499
Fax: 613-941-1668
Teletypewriter: 1-800-465-7735 (Service Canada)