QSA's Holiday Break in BioPharma (Issue #11, 2024)
Agile licensing changes; Pharmacare funding concerns; Biologics regulation updates; Drug standards modernized; Labeling requirements revised.
Start Date: 2024-12-14
End Date: 2025-01-03
Top Headlines
Main Stories
Agile Licensing Regulations Amended Under the Food and Drugs Act
The recent amendments to the Food and Drugs Act introduce an agile licensing framework, aiming to enhance the regulatory oversight of drugs and medical devices. The revisions focus on modernizing requirements for biologics, enabling flexible terms and conditions for drug and device licenses, and improving post-market surveillance. These changes are expected to save manufacturers approximately $9.5 million annually by reducing administrative burdens and aligning with international standards. Health Canada emphasized the importance of adapting to rapid innovations in the industry, which these amendments aim to address.
Sources: ['Canada Gazette, Part II: www.gazette.gc.ca']
