Blogs

Health Canada has announced changes to the filing requirements for Extensible Markup Language (XML) Product Monographs (PMs), signaling a shift toward enhanced digital documentation standards. The first phase of these requirements come into effect on July 18, 2025. These updates will impact regulatory teams, requiring adjustments in their processes to meet the new expectations.

As the healthcare industry undergoes rapid transformation, it is shifting away from product information (PI) based on physical and unstructured digital formats to electronic data formats offering greater accessibility, interoperability, and potential for global alignment. A key factor in this transformation is the data standard Fast Healthcare Interoperability Resources (FHIR).

When you work in a regulated industry where the risk of mistake is high, staying proficient with your tech stack and compliant with evolving standards is essential. With TVT being a cornerstone for many professionals in document review and labeling accuracy, Schlafender Hase has introduced a comprehensive e-Learning portal.

With growing demands on regulatory professionals to ensure accuracy and efficiency, the newest version of the industry-trusted proofreading software, TVT 12 delivers enhancements that allow users to navigate complex document requirements with greater ease and confidence.

The life science industry is poised to undergo significant shifts, driven especially by new technologies in healthcare. Technologies are also driving greater transparency in supply chains. Other features of the industry landscape that we foresee for 2025 are a more globally harmonized regulatory framework.

Schlafender Hase follows a customer-led development process of continuously incorporating feedback from its users into every TVT upgrade.