Links: Regulatory guidance

EMA template guidance: version 8

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.

A new template (version 8) was published in Summer 2011. This signals a much more flexible approach from the QRD than ever before, 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 it!

The new template is much less rigid. 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.

Key changes are:

• The convention on frequency of side effects: wording tested and proposed by Consumation has been broadly accepted (up to 1 in every 1,000 people is recommended, rather than 1 to 10 in 10,000)
• "Before you take X" becomes "What you need to know before you take X"
• "Take special care with X" becomes "Warnings and precautions"
• There is a new heading for children and adolescents
• "Pregnancy and breast-feeding" becomes "Pregnancy, breast feeding and fertility" (where relevant)

Free PDF download

The European Commission’s “readability guideline”

This is the core text for anybody drafting leaflets or needing to run usability testing in Europe. It’s often known simply as the European guideline. Legally, it is more significant than any of the individual regulators’ guidelines (eg Afssaps, BfArM, EMA or MHRA), and it’s relatively concise at 27 pages. It sets out legal obligations, some practical guidance on leaflets, and a suggested test method. Free PDF download.

Other EMA guidance

Useful start page for European document requirements.

Other UK guidance

Patient information is the subject of more regulatory guidance than any other area of the MHRA’s operations. This link takes you to the best start page on the MHRA’s web site.