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The application dossier for marketing authorisation is called a New Drug Application (NDA) in the USA or Marketing Authorisation Application (MAA) in the European Union and other countries, or simply registration dossier. This contains data proving that the drug has quality, efficacy and safety properties suitable for the intended use ...
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.
Faculty of Commerce, Banaras Hindu University (FOC-BHU), also known as Shri Thakur Ratan Pal Singh Faculty of Commerce [citation needed] is a faculty in the Banaras Hindu University, Varanasi, India which offers undergraduate, postgraduate and doctorate courses in Commerce. It was founded in 1940.
The content and the format for drug master file used in United States differs from that used in European Countries to obtain market authorization (MA). The Main Objective of the EDMF is to support regulatory requirements of a medicinal product to prove its quality, safety and efficacy. This helps to obtain a Marketing Authorisation grant.
There are two types of evaluation: dossier evaluation and substance evaluation: Dossier evaluation is conducted by authorities to examine proposals for testing to ensure that unnecessary animal tests and costs are avoided, and to check the compliance of registration dossier with the registration requirements.
The Institute of Medical Sciences (IMS-BHU) is one of the Six institutes of Banaras Hindu University in Varanasi, India and comprises three faculties, Faculty of Medicine, Dental Sciences, and Ayurveda. [1] The Institute of Medical Sciences is the medical school of the university. Like other institutions forming BHU, it is residential and co ...
The Banaras Hindu University (pronunciation ⓘ) (BHU), is a collegiate, central, and research university located in Varanasi, Uttar Pradesh, India, and founded in 1916.The university incorporated the Central Hindu College, which had been founded by theosophist and future Indian Home Rule leader Annie Besant in 1898.
Like ordinary EMA marketing authorisations, a PUMA approval is valid in all countries of the European Economic Area (the European Union as well as Iceland, Liechtenstein, and Norway). The PUMA process was established to make it more profitable for pharmaceutical companies to market drugs for children.