Article

Proving equivalence of originator and an authorized generic drug following EMA draft guideline on quality and equivalence of topical products

2024-06-06

Abstract excerpt

<h4>Aim: </h4> Today, the approval for a generic topical product includes the presentation of therapeutic equivalence to the originator based on clinical trials. To facilitate this procedure, in 2018 the European Medicines Agency (EMA) published a draft guideline on quality and equivalence of topical products, which includes request parameters regarding the quality of the newly developed generic product and test p...

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Literature Corpus work: a7bc97c0-16fb-5afd-9876-5f77a50f05a7
DOI: 10.22541/au.171600574.43353285/v2

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