Different pharmaceutical products need similar terminology.
Ontology highlight
ABSTRACT:
SUBMITTER: Crommelin DJ
PROVIDER: S-EPMC3889525 | biostudies-other | 2014 Jan
REPOSITORIES: biostudies-other
Publications
Different pharmaceutical products need similar terminology.
Crommelin Daan J A DJ de Vlieger Jon S B JS Weinstein Vera V Mühlebach Stefan S Shah Vinod P VP Schellekens Huub H
The AAPS journal 20130925 1
In the last decade, discussions on the development of the regulatory framework of generic versions of complex drugs such as biologicals and non-biological complex drugs have attracted broad attention. The terminology used is far from harmonized and can lead to multiple interpretations of legal texts, reflection papers, and guidance documents regarding market introduction as well as reimbursement. This article describes the meaning of relevant terms in different global regions (Europe, USA, WHO) ...[more]
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