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Health Canada Drug Approval Pathways 2025: A Complete Guide for Global Pharma Companies Shifting Ground of Drug Approvals in Canada In 2025, Health Canada has recast its methodology for overseeing pharmaceuticals, biologics, and innovative therapies. Through advanced Regulatory Affairs Services, the agency’s shifting framework mirrors a worldwide move toward speedier, science-driven, and technology-enabled review processes. For international pharma and biotech organizations, knowledge of these drug approval routes is key to organizing an effective, compliant, and competitive market penetration of Canada. Health Canada's modernization is designed to maintain stringent standards of safety and efficacy while facilitating patient access to new treatments more quickly. The increasing harmonization with global regulators such as the FDA and EMA has made Canada one of the most forward-thinking drug regulatory environments in the world. Therapeutic Products Directorate (TPD) – for pharmaceuticals and medical devices. Biologics and Genetic Therapies Directorate (BGTD) – for biologics, vaccines, and gene or cell-based treatments. The two directorates are responsible for assuring that drugs are of safety, efficacy, and quality standards under the Food and Drugs Act and its supporting regulations. Read the Full blog, to know more : https://resource.ddregpharma.com/blogs/health-canada-drug-approval-pathways-2025-a-complete-guide-for-global-pharma-companies/ Follow us on : Facebook: https://www.facebook.com/DDReg/ LinkedIn: https://www.linkedin.com/company/ddregpharma Twitter: https://x.com/DDRegPharma

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Regulatory Oversight of Companion Apps: Where Do They Stand? Picture having your morning coffee while an app automatically syncs with your glucose meter. These are companion apps, software extensions of medical devices. But with great innovation comes great responsibility. So, who oversees that these apps are safe, work as intended, and remain secure? Companion apps, particularly in healthcare, are rising fast. But the regulatory frameworks that govern them? In this blog, we’ll break down how these apps are regulated globally and what it means for patients, providers, and developers alike. U.S. FDA: A Risk-Based, Multi-Agency Model In the US, companion app regulation is guided by a risk-based, function-specific approach spearheaded by the Food and Drug Administration (FDA) but augmented by agencies such as the FTC, HIPAA-covered entities, and the Consumer Financial Protection Bureau (CPFB). Such a multi-agency network guarantees proper vigilance on safety, privacy, and consumer protection for apps in health, wellness, and financial spaces. Developers must also consider the need for regulatory services in uae if they plan on entering the Middle East market, as the regulatory requirements are equally stringent there. FDA Oversight of Medical Device Apps The FDA oversees digital health applications that fit the definition of a medical device under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Software that diagnoses a medical condition, offers treatment guidance, controls or interacts with hardware medical devices. Read the Full blog, to know more : https://resource.ddregpharma.com/blogs/regulatory-oversight-of-companion-apps-where-do-they-stand/ Follow us on : Facebook: https://www.facebook.com/DDReg/ LinkedIn: https://www.linkedin.com/company/ddregpharma Twitter: https://x.com/DDRegPharma

The Global Food Grade Release Agent Market is witnessing steady expansion, with industry sales projected to reach USD 1,262.2 million by the end of 2025 and exceed USD 2,135.7 million by 2035, registering a 5.4% CAGR over the forecast period (2025–2035). Grab This Report Now at Just $ 3500| Limited-Time Discount Offer! https://www.futuremarketinsights.com/reports/sample/rep-gb-15257 Checkout Now to Access Industry Insights: https://www.futuremarketinsights.com/checkout/15257

The global plant-based pet food market is on a trajectory of significant growth, with a new market outlook report forecasting a valuation of USD 57.3 billion by 2034. The industry, valued at USD 26.9 billion in 2024, is projected to expand at a robust compound annual growth rate (CAGR) of 7.8%. Grab This Report Now at Just $ 3500| Limited-Time Discount Offer! https://www.futuremarketinsights.com/reports/sample/rep-gb-14212 Checkout Now to Access Industry Insights: https://www.futuremarketinsights.com/checkout/14212

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