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 important, the patients themselves. Legislation in the US 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, etc.
The EU Clinical Trials (CT) Directive 2001/20/EC was first published in April 2001 whereby it was to be made a legal requirement within EU member states from May 2004 onwards through the transposition of the Directive into the local EU countries’ legal framework (e.g. Statutory Instrument within the UK).
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