Excipient makers raise concern over EU risk assessment deadline
This article was originally published in SRA
Executive Summary
Excipient producers and distributors have warned that the European Commission's deadline of 21 March 2016 by which all drug makers in the EU must carry out a formal risk assessment of the excipients they use in their medicinal products is too short and may jeopardize the availability of high quality excipients that have been in use for many years1.