European Commission Recommends Changes to SmPC, Package Leaflets

Regulatory NewsRegulatory News | 27 March 2017 |  By 

The European Commission last week released a report detailing recommendations to improve the information provided to patients and healthcare professionals for approved drugs.

In its report, the Commission says that the European Medicines Agency (EMA) should update its guidelines to improve the comprehension and readability of package leaflets (PL) and summary of product characteristics (SmPC) to safe use of drugs in the EU.

The report itself takes into account the result of two studies, referred to as PIL-S and PILS-BOX, carried out by the Netherlands Institute for Health Services Research (NIVEL) and the University of Leeds, as well as input from an EU-wide survey of stakeholders and member states.

According to the Commission, the two studies were aimed at assessing the readability and comprehensibility of the SmPC and PL and to determine whether a "key information section" should be added to both documents.

According to the report, it's still too early to tell whether a "key information" section should be added to the SmPC and package leaflet.

As envisioned, the key information section would call attention to particularly relevant information about a drug to ensure its safe and effective use.

However, the Commission says there isn't enough evidence to show the usefulness of adding such a section, and says it will look to work being done by EMA to test a similar concept for its European public assessment reports (EPARs) to help inform whether adding the section is useful down the road.


Based on the results of the two studies and stakeholder input, the Commission says there's more room for improving the package leaflet than for the SmPC.

"As far as the PL is concerned, patient's comprehension of the PL and its readability can be improved. The language used is often too complex and the design and layout are not always user-friendly. The elderly and those with low literate skills are particularly disadvantaged, but generally these problems hold for all patient groups," the Commission says.

While the Commission says there were fewer issues identified for the SmPC, it notes that physicians' understanding of the document could still be improved with greater readability.

EMA currently has several guidelines to assist sponsors with developing the SmPC and package leaflet for their products, and the agency's Quality Review of Documents (QRD) working group has produced a number of templates detailing the official wording that should be used in the documents in order to promote consistency across various products.

However, the Commission says that EMA should look to update its guidelines and the QRD templates to simplify the information provided and improve their layout.

"Guidelines should include more details on the principles of good information design in which content and layout are jointly considered. This would help to ensure compliance with the legal requirement that the PL shall be 'clearly legible,'" the Commission says, noting that small font size, narrow line spacing and overall length of the package leaflet were the main offenders.

Additionally, the Commission says the guidelines and QRD templates are "too restrictive," and recommends they be amended to allow for more flexibility to be tailored to specific products.

"Deletion of some information that is currently required by the QRD template but that is of limited relevance for patients may allow more space to improve the content and layout of the package leaflets and should, therefore, be considered," the Commission says.

Another issue, the Commission notes, is that the package leaflet can sometimes be obscured when it is translated into other languages.

"The aim should be to ensure that the lay language introduced through user testing in the original version is not lost during translation," the Commission says.

When it comes to developing the package leaflet, the Commission says that the process for gathering patient input could be improved by making the user testing process more iterative.

"Iterative user-testing would be coordinated by regulatory authorities in parallel to the assessment in a way that does not disrupt the whole marketing authorisation process [and] should focus on the content of the PL, rather than the format and layout," the Commission says.

European Commission


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