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Is generic medicines approved by a regulatory authority?

Updated: 8/21/2019
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7y ago

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Even for equivalent medicines the marketing authorization is provided by the regulatory authorities like FDA. However, manufacturers of generics do not have to repeat the safety and efficacy studies: these in fact had already been conducted by the originator of the product manufacturer at the time of the first approval. Simply so that present to the Agency a dossier demonstrating the bioequivalence of the product, the ability of the production and the measures adopted to ensure the quality control process.

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