The rising costs of new medicinal products are a challenge to the economic sustainability of national healthcare systems in ensuring patients' access to therapies. European Union (EU) and US legislators have provided regulatory pathways aimed at simplifying Marketing Authorization (MA) applications for new medicinal products in cases when safety and efficacy profiles can be derived from the data of already-marketed products. In this review, we discuss the different regulatory pathways towards the MA of new medicinal products containing old drug substances and intended to improve the therapeutic value of a treatment, to obtain a new therapeutic indication (drug repositioning), or to ensure the same therapeutic value of a reference product at lower costs.

Old active ingredients in new medicinal products: is the regulatory path coherent with patients' expectations? / P. Minghetti, U.M. Musazzi, A. Casiraghi, P. Rocco. - In: DRUG DISCOVERY TODAY. - ISSN 1359-6446. - (2020). [Epub ahead of print]

Old active ingredients in new medicinal products: is the regulatory path coherent with patients' expectations?

P. Minghetti
Primo
;
U.M. Musazzi
Secondo
;
A. Casiraghi
Penultimo
;
P. Rocco
Ultimo
2020

Abstract

The rising costs of new medicinal products are a challenge to the economic sustainability of national healthcare systems in ensuring patients' access to therapies. European Union (EU) and US legislators have provided regulatory pathways aimed at simplifying Marketing Authorization (MA) applications for new medicinal products in cases when safety and efficacy profiles can be derived from the data of already-marketed products. In this review, we discuss the different regulatory pathways towards the MA of new medicinal products containing old drug substances and intended to improve the therapeutic value of a treatment, to obtain a new therapeutic indication (drug repositioning), or to ensure the same therapeutic value of a reference product at lower costs.
Drug repositioning; Fixed combinations; Hybrid applications; Marketing authorization; Non-biological complex drugs; Old drugs
Settore CHIM/09 - Farmaceutico Tecnologico Applicativo
2020
31-mag-2020
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/737995
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