Results for tag: "FDA Vs Health Canada"

The pharmaceutical manufacturing market in the United States is regulated by the Food and Drug Administration (FDA), while in Canada it is regulated by Health Canada. The FDA is responsible for ensuring the safety and efficacy of drugs, biologics, and medical devices, while Health Canada is responsible for the safety, efficacy, and quality of health products. Both organizations have similar standards for the approval of drugs and medical devices, but the FDA has more stringent requirements for clinical trials and post-market surveillance. The FDA and Health Canada also have different requirements for the manufacturing of pharmaceuticals. The FDA requires manufacturers to adhere to Good Manufacturing Practices (GMPs) and Quality System Regulations (QSRs), while Health Canada requires manufacturers to adhere to the Good Manufacturing Practices (GMPs) and the Canadian Medical Devices Regulations (CMDR). Companies in the pharmaceutical manufacturing market include Pfizer, Merck, Johnson & Johnson, Novartis, GlaxoSmithKline, Sanofi, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, and Amgen. Show Less Read more