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- W83023226 abstract "This article describes the European regulatory requirements for marketing authorization of drugs. Different regulatory procedures have been implemented in order to achieve a final product with scientifically contrasted quality, safety, and efficacy and a favorable risk–benefit balance. The European Medicines Agency acts as a hub for nearly 40 national regulatory authorities in Europe, and is in contact with other international organizations. European regulation is compiled in volumes 1 and 5 of ‘The rules governing medicinal products in the European Union.’ The main legislative acts are Directives 2001/83/EC and 2001/82/EC, as amended, for human and veterinary medicinal products, respectively." @default.
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- W83023226 date "2014-01-01" @default.
- W83023226 modified "2023-10-02" @default.
- W83023226 title "Drug Regulations, Europe" @default.
- W83023226 doi "https://doi.org/10.1016/b978-0-12-386454-3.00583-2" @default.
- W83023226 hasPublicationYear "2014" @default.
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