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registration dossiers ("Registration Dossier" of the pharmaceutical product is a document that contains all the technical data (administrative, quality, nonclinical and clinical) of a pharmaceutical product to be approved / registered / marketed in a country. It is more commonly called as the New Drug Application (NDA) in the USA or Marketing Authorization Application (MAA) in the European Union (EU) and other countries, or simply Registration Dossier. Basically, this consists of data proving that the drug has quality, efficacy and safety properties suitable for the intended use, additional administrative documents, samples of finished product or related substances and reagents necessary to perform analyzes of finished product. Therefore, they are the vehicle in a country through which drug sponsors formally propose that the Regulatory Agencies approve a new pharmaceutical for sale and marketing. Alexander Demidov); new drug application (The New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the Food and Drug Administration (FDA) approve a new pharmaceutical for sale and marketing. The goals of the NDA are to provide enough information to permit FDA reviewers to establish the following: Is the drug safe and effective in its proposed use(s) when used as directed, and do the benefits of the drug outweigh the risks? Is the drug’s proposed labeling (package insert) appropriate, and what should it contain? Are the methods used in manufacturing (Good Manufacturing Practice, GMP) the drug and the controls used to maintain the drug’s quality adequate to preserve the drug’s identity, strength, quality, and purity? WK Alexander Demidov); MAA (Alexander Demidov); application dossier (The application dossier for marketing authorization is called New Drug Application (NDA) in the USA or Marketing Authorization Application (MAA) in the European Union and other countries, or simply registration dossier. Basically, this consists of a dossier with data proving that the drug has quality, efficacy and safety properties suitable for the intended use, additional administrative documents, samples of finished product or related substances and reagents necessary to perform analyzes of finished product as described in that dossier. The content and format of the dossier must follow rules as defined by the competent authorities. For example, since year 2003, the authorities in the United States, the European Union and Japan ask for the Common Technical Document (CTD) format, and more recently, its electronic version – the electronic Common Technical Document (eCTD). WK Alexander Demidov) |
