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Supplementary protection certificates were introduced to encourage innovation by compensating for the long time needed to obtain regulatory approval of these products (i.e. authorisation to put these products on the market). [1] A supplementary protection certificate comes into force only after the corresponding general patent expires.
Instituto Nacional de Medicamentos (INAME) 2008 Australia: Therapeutic Goods Administration (TGA) 1995 Austria: Federal Office for Safety in Health Care Bundesamt für Sicherheit im Gesundheitswesen (BASG) 1999 Belgium: Federal Agency for Medicines and Health Products Agence Fédérale des Médicaments et des Produits de Santé (AFMPS)
In 2011, the American Medical Association recommended a uniform prior authorization form with real-time electronic processing. The proposed process would involve a physician ordering a medical service, their staff completing a standardized request form, and an electronic submission process with same-day approval or denial.
Prior to the Prescription Drug User Fee Act (PDUFA), median approval times of New Drug Applications ranged between 21 and 29 months. [2] The Prescription Drug User Fee Act was first passed in 1992 to facilitate the funding of the Food and Drug Administration while ensuring a more predictable timetable for drug approvals . [ 3 ]
The Spanish Agency of Medicines and Medical Devices (Spanish: Agencia Española de Medicamentos y Productos Sanitarios; AEMPS) is a regulatory and autonomous agency of the Government of Spain that acts as the highest sanitary authority in the country in terms of medical safety on medicines, health products, cosmetics and personal care products.
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.
Like other food substances, dietary supplements are not subject to the safety and efficacy testing requirements imposed on drugs, and unlike drugs they do not require prior approval by the FDA; [40] however, they are subject to the FDA regulations regarding adulteration and misbranding. The FDA can take action against dietary supplements only ...
Type approval or certificate of conformity is granted to a product that meets a minimum set of regulatory, technical and safety requirements. Generally, type approval is required before a product is allowed to be sold in a particular country, so the requirements for a given product will vary around the world.