Scanning the regulatory horizon 2013
After two meetings in 2012, and a pan-European survey in spring of 2013, we have signposts for the way European labelling is heading.
The options included summary headlines, first championed the MHRA in the UK, but are backed by little published research. Typically, these might comprise 6 or 7 bullet points, comprising the most important safety or usage points about a given medicine.
Summaries are popular with readers – easier than reading the whole leaflet – but give rise to some problems. First, the better the summary, the less likely that users will read the rest of the leaflet, all of which is regarded as essential in regulatory terms. A second problem is who defines what are the key points, when a leaflet is so drastically reduced? Consumation's own experience with "summary headlines" is mixed: with careful design and cross referencing, they can support the full leaflet, but the risk that users only read the summary is always there.