Fda Drug Review Process

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Comparison USA FDA, Health Canada, and EMA The regulatory body in USA is the FDA, in the European Union the EMA, the European Commission and the national authorities of the EU member states and in the Canada the Health Canada handle the drug review processes. Each agency has their own distinctive approaches to approve drugs biologics and medical devices. The globalization of the pharmaceutical industry, harmonising the drug regulatory approval process of the US FDA and EU EMA, and Health Canada is essential to speed up the progress of new treatments. The main goal of all agencies is to put a drug in the market in safe, efficient and faster. We will examine here the agencies’ approval process time frame and other drug approval pathways. USAFDA…show more content…
Centralized Authorization Procedure -pharmaceutical companies needs to submit a ‘dossier’ of scientific information on quality, efficacy and safety to support a single marketing authorization application to EMA to market the medicine throughout the EU including European Economic Area countries Iceland, Liechtenstein and Norway. Two committees of EMA; Committee for Medicinal products for Human Use (CHMP) or Committee for Medicinal products for Veterinary Use (CVMP) conduct a scientific evaluation of the application and give an opinion on about drug to market or not to market (EMA,2016). The centralized procedure is essential for human medicines containing a new active substance to treat HIV or AIDS, cancer, Diabetes, neurodegerative dieses, autoimmune diseases and viral diseases biologics, advance therapy Medicine, orphan medicines and veterinary medicines. 2. National Authorization Procedure- The most of medicines available in the EU were authorized at national level, either because they got approval before EMA’s establishment or they were out of the scope of the centralized procedure scope. Each EU Member State has its own national authorization procedures.If a company desires to get marketing authorization of their product in numerous EU Member States which is out of centralized procedure scope, they can apply through one of the following…show more content…
If a new drug has potential therapeutic value that outweighs the risks an applicant needs to submit drug submission for new drug or biologic to the Health Canada’s Health Products and Food Branch (HPFB) to pursue a review and, ultimately, regulatory approval (Health Canada, 2016). Canadian regulations need preclinical and clinical trials to get a marketing approval in Canada. The HPFB assesses and observes the safety, efficacy and quality of drugs used for human and animal, medical devices, natural health and other therapeutic products. A manufacturer may apply for the Generic product via Abbreviated NDS (ANDS). In Canada, medical devices are divided into four classes based on the level of risk connected with their use, Class I devices present the lowest potential risk like thermometers that do not require a medical device license. Class II, III and IV devices required a medical device license to sell the products legally in the
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