EU updates excipient labelling guidance
of excipients used in medicinal products and the manufacturing of
investigational drugs.
The European Commission has updated its guidelines on the labelling of excipients used in medicinal products.
An Annex to the document provides a list of the excipients which should be stated on the labelling and outlines the information which should appear in the package leaflet for these excipients.
"In general, excipients are considered to be 'inert'. Whilst it is desirable that excipients should have little or no pharmacological action of their own, some do indeed have a recognised action or effect in certain circumstances," the guideline points out. Those excipients included in the Annex all have recognised side effects, for example they may be associated with allergic reactions or have irritant properties.
The document does not apply to these substances when they are used as active substances, and excludes compounds which may be present in finished medicinal product as a result of the manufacturing process, e.g. impurities or residual solvents.
Meanwhile, the Commission has also provided supplementary guidance on current Good Manufacturing Processes (cGMP) for investigational medicinal products (Annex 13), intended to ensure that trial subjects are not placed at risk, and that the results of clinical trials are unaffected by inadequate safety, quality or efficacy arising from unsatisfactory manufacture.
