Good morning! Welcome back to Queen Street Analytics' weekly roundup of regulatory developments, legislative discussions, political announcements and other government-related news in biotech, pharmaceutical manufacturing, drug distribution and pricing, the life sciences and medical research.

Every Monday, we break down the most important updates in this space in under five minutes.

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Start Date: 2025-03-23
End Date: 2025-03-29

Top Headlines

Main Stories

Health Canada Introduces New FDA Authority

Health Canada has amended the Food and Drugs Act (FDA) under the Budget Implementation Act, 2024, No. 1, granting the Minister a new authority to issue targeted exemptions for foods and therapeutic products. This change aims to address challenges in global markets and ensure safety and availability, enabling precise regulatory solutions to emerging issues.

Sources: Canada Gazette, Part II: www.gazette.gc.ca

Exemption Order for NHP Labeling Requirements

A new exemption order under the FDA has been enacted concerning labeling requirements for certain natural health products (NHPs). This follows extensive consultations with industry associations, highlighting the need to simplify labels and leverage digital solutions. The exemption addresses industry concerns over timelines and guidance materials.

Sources: Canada Gazette, Part II: www.gazette.gc.ca

Canada Gazette Waives Info Requirements for Living Organisms

Announcement of waivers for information requirements under the Canadian Environmental Protection Act for various companies, including AskBio Inc. and Vaccigen. This waiver pertains to data on ecological effects and antibiotic susceptibility, facilitating processes for importing or manufacturing living organisms not on the Domestic Substances List.

Sources: Gazette, Part I: www.gazette.gc.ca

Provincial Announcements

B.C. Spring COVID-19 Vaccine Program

B.C. launches a free COVID-19 vaccine program starting April 8, targeting high-risk groups, alongside increased measles awareness due to travel-linked cases.

Sources: Provincial Announcement: news.gov.bc.ca

Quebec Budget Allocates Billions for Services

Quebec's budget includes over $6.8 billion to improve health care, education, and social services, focusing on accessibility and quality enhancements.

Sources: Provincial Announcement: www.quebec.ca

Public Officials' Social Media

François-Philippe Champagne on Innovation

MP François-Philippe Champagne shared a tweet on Canada's potential in exploring, extracting, and exporting innovative products, including medicine, to transform industries.

Sources: Social Media: x.com

Stan Kutcher's Op-Ed on Health Research

Senator Stan Kutcher tweeted an op-ed on Canada's opportunity to attract scientific talent amid U.S. shifts away from discovery research, stressing investment in health research.

Sources: Social Media: x.com

What We're Reading This Week

• When it comes to funding for novel drugs and devices, waiting for a government decision is the most painful part: Insights into the challenges of securing governmental funding for innovative drug and device development.
• B-Cell Lymphoma Clinical Trials and Studies 2025: Overview of clinical trials and studies on B-Cell Lymphoma, including recent approvals and mechanisms of action.
• Quantum Biopharma's 2024 Financial Statements: Highlights of Quantum Biopharma's improved financial position and operating efficiency.
• European Medicines Agency Validates Henlius and Organon Filing: Details on EMA's validation of biosimilar candidate filings by Henlius and Organon.