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In most countries, a marketing authorisation is valid for a period of 5 years. After this period, one should apply for renewal of the marketing authorisation, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product is still favourable.
The Marketed Health Products Directorate (MHPD) is the Canadian federal authority that monitors the safety and effectiveness of health products marketed in Canada. These include: [1] Prescription and non-prescription medications; Biologic medical products, including fractionated blood products; Therapeutic and diagnostic vaccines; Natural ...
A centralised marketing authorisation, issued by the European Commission, allows the holder to market a medicinal product throughout the European Economic Area (EEA), which comprises the EU Member States, Iceland, Norway and Liechtenstein. [2] In the United States, the equivalent process is called New Drug Application.
Prior to being given market authorization, a manufacturer must present substantive scientific evidence of a product's safety, efficacy, and quality as required by the Food and Drugs Act and Regulations. [1] It is one of the ten operational directorates of the Health Products and Food Branch, a branch of Health Canada.
Health Canada (HC; French: Santé Canada, SC) [NB 1] is the department of the Government of Canada responsible for national health policy.The department itself is also responsible for numerous federal health-related agencies, including the Canadian Food Inspection Agency (CFIA) and the Public Health Agency of Canada (PHAC), among others.
Medical Devices regulations cover all the topics related to the laws, standards or submissions process, with which compliance is required by manifold national and international bodies to commercialize a medical device
Post-marketing drug safety: The collection, analysis and distribution of data on the quality, efficacy, and safety data of medicines and medical devices; Advising consumers on approved products; Research on the development of industry standards; Victim compensation:
Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.