Guidance documents
EMA guidance: template version 10, and risk management in lay language
The pan-European regulator publishes a number of guidelines on its requirements for written style, for timetables, and process. But the single most important document is probably the "QRD template" – so called because it is produced by the Quality Review of Documents group, and sets out the model text and recommended statements that EMA expects European leaflets to include.
Version 10 is a development of the much more flexible approach from the QRD which started with versions 8 and 9, and will make it easier for companies to change their leaflets in line with user consultations – as the law requires. If you want to put a medicine on the market in Europe, you need to look at Version 10!
The most recent template much less rigid than earlier versions. It emphasises "readability" and "patient-friendly language", and explanation for the actions recommended. Be sure to look at the "annotated" version, which is where most of the QRD thinking is set out.
Recent developments of the template include reporting of side effects to national authorities, and a black triangle symbol for products requiring additional monitoring. Recent years have also seen the first experiences with lay summaries of risk management plans. As specialists in plain language for health consumers, we can help you bring your documents into compliance!