When a medicinal product (MP) and a medical device (MD) are combined, their correct classification implies discrimination among different possible scenarios, based on the nature of the combination and the principal mechanism of action. In the European Union (EU), stakeholders deal with a lack of harmonization, which can represent an obstacle toward the development of these products, and a complex nomenclature, emerging from two divergent regulatory philosophies (i.e., that of MPs and that of MDs). In the USA, where the US Food and Drug Administration (FDA) supervises MDs, drugs, and biological products, stakeholders interact with a single authority, where any issue is addressed internally.

Medicinal products meet medical devices: Classification and nomenclature issues arising from their combined use / P. Rocco, U.M. Musazzi, P. Minghetti. - In: DRUG DISCOVERY TODAY. - ISSN 1359-6446. - 27:10(2022 Oct), pp. 103324.1-103324.7. [10.1016/j.drudis.2022.07.009]

Medicinal products meet medical devices: Classification and nomenclature issues arising from their combined use

P. Rocco
Primo
;
U.M. Musazzi
Penultimo
;
P. Minghetti
Ultimo
2022-10

Abstract

When a medicinal product (MP) and a medical device (MD) are combined, their correct classification implies discrimination among different possible scenarios, based on the nature of the combination and the principal mechanism of action. In the European Union (EU), stakeholders deal with a lack of harmonization, which can represent an obstacle toward the development of these products, and a complex nomenclature, emerging from two divergent regulatory philosophies (i.e., that of MPs and that of MDs). In the USA, where the US Food and Drug Administration (FDA) supervises MDs, drugs, and biological products, stakeholders interact with a single authority, where any issue is addressed internally.
Co-packaged product; Combination product; Companion diagnostic; Drug-device combination; Integral product; Medical device; Medicinal product; Referenced products;
Settore CHIM/09 - Farmaceutico Tecnologico Applicativo
22-lug-2022
Article (author)
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2434/937407
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