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International Clinical Trials

A Question of Standards

In 2013, the International Society for Pharmaceutical Engineering (ISPE) launched a survey to analyse the relationship between patient compliance and packaging (1), in which subjects of clinical trials were asked about their experience when applying investigational medicinal products (IMPs). An overwhelming 77% found their medication easy to use. Since the questionnaire was almost exclusively based on responses by patients from the US, it was expanded in 2015 to include the UK, the EU and Asia. The favourable opinion was, again, confirmed: the majority of participants gave positive feedback regarding the overall ease of application of their IMPs – both in the EU (85%) and in China (88%).

The more user-friendly the labelling of IMPs is, the simpler they are to use. This equation takes centre stage considering the growing demand from subjects for medication to be delivered straight to their homes (75% in the EU; 78% in China; 78% in the US in 2013). In contrast to briefing on the phone – which always means extra work for site personnel – dosing instructions on the package are directly and durably attached to the drug. To be accessible, additional digital information usually requires analogue placeholders on the packaging – such as QR codes – which can only be read by means of technical devices. Having functioning hardware and software is, therefore, a prerequisite.

Just-In-Time Labelling


The labelling of IMPs is subject to demands that are specified in the Good Manufacturing Practice (GMP) Guide within the EU (2), and in the Code of Federal Regulations (CFR) in the US (3). They mostly apply to blister packs or bottles as far as the primary packaging of clinical IMPs is concerned, and to labels on secondary packaging. Label content is governed by EU stipulations in Annex 13 to the Guide, with layout, font size and symbols laid down in the Guideline on Readability (4).

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Nurdan Citamak joined Faubel Pharma Services in 2013 and was appointed Director of Business Development and Sales for North America. She graduated in Business Administration from Würzburg-Schweinfurt University, Germany, and majored in International Business at Bond University, Australia. Prior to joining the company, Nurdan spent nearly seven years in New York working in the technology industry.
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