Guidance Document Regarding Administrative Processing of Submissions and Applications: Human or Disinfectant DrugsPublished on April 23, 2019
Author: Bhavesh Patel, C. Chem.
Health Canada recently published a guidance document to clarify the requirements for eligible drug submissions and applications processed under the administrative pathway. The document replaces the Changes in Manufacturer's Name and/or Product Name Policy (CMPN), written in 1998 and updated in 2001, 2015 and 2017.
Stakeholder comments received on the draft guidance document during the 60 day consultation period (February 17th until April 18th, 2017) were considered in the finalization of this guidance document.
As of March 1st, 2018, sponsors wishing to file submissions and applications under the administrative pathway are required to do so per the conditions set out in the guidance document. Among these conditions is the requirement to file a drug submission or application with supporting data if certain deviations are made to a cross-licensed product in terms of its labelling, chemistry and manufacturing. These changes are not eligible for processing under the administrative pathway. In cases where deviations from the parent product are filed and authorized, the cross-licensed product would no longer be eligible for any future post-authorization filings under the administrative pathway for labelling or chemistry updates to match the licensor, as aspects of the authorization would no longer be considered identical to the licensor. Also, please note that for disinfectant drugs, the implementation date of the aforementioned guidance document is April 1, 2019.
Thank you for reading Regulated Affairs, the CAPRA Blog. CAPRA is a non-profit organization dedicated to providing professional development opportunities in Regulatory Affairs. Feel free to share our blog posts and join us on social media.
Bhavesh Patel is an active member of CAPRA Education Day and Website Committee and has been working with CAPRA for 10 years. Bhavesh has 10 years of experience in Regulatory Affairs in Canada. His regulatory experience encompasses prescription drugs, non-prescription drugs, natural health products, medical devices, cosmetics and foods. In his spare time, he enjoys professional writing, which includes regular contributions to the CAPRA online Blogs. Recently, Bhavesh co-authored chapters for the RAPS 2018 book, “Fundamentals of Canadian Pharmaceutical and Biologics Regulations”.
Technology Continues to Transform Healthcare and the Regulatory World
Introduction: Digital health solutions are advancing rapidly in the field of diagnostics, emergency response, hospital management. As the goal of individuals shifts more...
Rare Diseases and Orphan Drugs Regulatory Framework in Canada: Recent Initiatives by Government of Canada
What are Rare Diseases and How do They Affect Canadians? According to Health Canada, rare diseases are life-threatening, debilitating, or serious and chronic conditions that...
Health Canada changes filing requirements for product monographs
Did you know, effective immediately, Health Canada is changing the submission requirements for second language product monographs for human drugs? This is for only post-life...