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Sie suchen in allen Bereichen nach dem Autor Matt S.
In der Rubrik Zeitschriften haben wir 2 Beiträge für Sie gefunden
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MerkenRegulatory requirements for combination products in the European Union and the United States of America
Rubrik: europharm
(Treffer aus pharmind, Nr. 11, Seite 1435 (2020))
Regulatory requirements for combination products in the European Union and the United States of America / Differences and similarities – Part 2*Part 1 see Pharm Ind. 2020;82(10):1304–1316. · Matt S1, Prinz H2 · PDM-Consulting, Weinheim und Groß-Zimmern
Combination products in the EU are either authorised as medicinal products or medical devices. A summary is provided in Table 6. Combination product Regulation (EU) 2017/745 Articles 1(7), 1(8), 1(9) Directive 2001/83/EC Article 10(b) Regulation (EC) No 1394/2007 Article 2(d) Regulation (EU) 2017/746 Article 2(7) Depending of principal mode of action Regulation (EU) 2017/745 Article 1, 6(b) or Directive 2001/83/EC Borderline products Regulation (EU) 2017/745 Medical Device Coordination Group ß Product path Medicinal Product Medical Device Legal definition Directive 2001/83/EC Article 1(2) Regulation (EU) 2017/745 Article 2(1) Lead Review EMA/NCAs Notified Body Clinical trials, clinical evaluations Directive 2001/20/EC (Regulation EU No ...
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MerkenRegulatory requirements for combination products in the European Union and the United States of America
Rubrik: europharm
(Treffer aus pharmind, Nr. 10, Seite 1304 (2020))
Regulatory requirements for combination products in the European Union and the United States of America / Differences and similarities – Part 1 · Matt S1, Prinz H2 · PDM-Consulting, Weinheim und Groß-Zimmern
Combination products in the United States (US) are defined in title 21, part 3, section 3.2(e) of the Code of Federal Regulations (21CFR3.2(e)) as therapeutic and diagnostic products that combine drugs, devices, and/or biological products. In 21CFR4.2 the individual components included in combination products are referred to as so-called “constituent parts” [1]. Products comprising e.g. two drug components, two device components or two biologic components are not combination products within the scope of these regulations. Similarly, combinations of a medical product with a non-medical product (e.g. a dietary supplement, cosmetic, or food) are not combination products. [2] According to 21CFR3.2(e) a ...
