Drug Master Files, manufacturer listings, and Electronic Common Technical Document (eCTD) submissions are foundational to regulatory compliance. Yet even experienced regulatory, quality, and operations...
The global Unique Device Identification (UDI) landscape is entering a critical enforcement phase — and 2026 will be a challenging year for medical device manufacturers operating in the European Union...
The FDA’s final rule, “Revising the National Drug Code Format and Drug Label Barcode Requirements,” establishes a uniform 12-digit format for FDA-assigned National Drug Codes (NDCs) ...
UDI product data is now due for specific scenarios (enforced as of December 8, 2022). Class I and Unclassified medical devices that are required to be labeled with a UDI code must submit product data...
LexisNexis Life Sciences Solutions and ONIX expand strategic alliance to guide pharma customers to market faster Professionals in the life sciences industry rely on unique regulatory affairs expertise...
Effective March 10, 2023, Health Canada changed submission requirements for second-language product monographs for human drugs. This change no longer requires the second language product monograph at the time of submission filing or review. However, both English and French languages need to be on the Drug Product Database (DPD) online and Drug and Health Product Portal (DHPP).
What is included? Rx and over-the-counter pharmaceutical drugs, biologics and radiopharmaceuticals.
What is not included? Labels and package inserts.
It is also important to note that both English and French product monographs are required post-authorization without exception. While this updated requirement provides a cushion of time before the second language product monograph is required, it does not change the product monographs ultimately.
Health Canada has provided this chart for easy reference:
Health Canada is implementing regulations requiring labeling and listing to be submitted in XML PM (eXtensible Markup Language Product Monograph) format. Health Canada is currently accepting voluntary XML PM submissions and is working to prepare the XML PM Guidance along with samples for public comment.
We will provide more information about how these guidances will affect one another once it is available.
Questions about Health Canada XML PM or ready to get started with your submissions? Visit our pharma solutions page or explore the Health Canada XML PM webinar and Health Canada's progress on the XML Product Monograph requirement.
Source: Health Canada — Changes to filing requirements for product monographs
Contact us