Current Edition

Medicinal Products for Human Use and Clinical Trials in the EU – A Changing Regulatory Landscape

Bringing new drug products from early discovery, through
clinical trials and into commercialisation is a challenging,
costly and time-consuming process. It involves multiple
stakeholders within sponsor companies, contract service
providers, regulatory authorities and, most importantly, the
patients themselves. Legislation in the USA has been present
for many years concerning clinical supplies which must be
manufactured “to an appropriate level of current Good
Manufacturing Practice” (cGMP). However, the European Union
(EU) clinical trial legislation is much more recent and specific
with respect to manufacture, labelling, release, regulatory
oversight. Tristram Evans at PCI Pharma Services UK submits
an overview on medicinal products for human use and clinical
trials in the EU.