Assessments carried out in cooperation with target patient groups

Legislation

To fulfill the requirements of articles 59(3) and 61(1) of Council Directive 2001/83/EC, as amended by Directive 2004/27/EC (*Reference 1), it is necessary for the Package Leaflet (Patient Information Leaflet) to 'reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use'. The results of assessments carried out in cooperation with target patient groups 'need to be provided to the competent authority'.

User Testing is a commonly accepted way to satisfy these requirements. The process involves showing the leaflet to ‘people who are likely to rely on the package leaflet' (*Reference 2) and identifying the areas where improvements are necessary to ensure that the leaflet is legible, clear and easy to use.

Our User Testing Services

Cambridge Regulatory Services employs a User Testing method developed in Australia in the 1990s, which is outlined in the EU and MHRA guidelines (*References 3 and 4).

Each project is different, however clients are likely to require a level of service which includes the following:

A more comprehensive service, especially tailored for your company, is also available. This comprehensive package can include such services as; patient leaflet bridging strategies, harmonisation of leaflets across a product range, reformatting leaflets to the QRD template and leaflet mock-up design.

To request further information on our services please email info@cambreg.co.uk or go to our contact page.

How long does it take?

To date, we have successfully met the deadlines imposed by all our clients. Some of our tests have been completed in less than 4 weeks; others take place over several months. 6-8 weeks is a comfortable timescale for most projects.

Does User Testing make any difference to readability of leaflets?

There are many aspects of leaflet production that limit the scope for improvement (especially cost and size), so not all leaflets can be improved to the best possible standard. However, our accumulated experience of writing and testing leaflets for different therapeutic areas has shown that at the end of the testing process every leaflet is significantly improved.

Does the User Testing legislation affect you?

Do all your products need testing?

The requirement to ‘reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use' applies to the leaflets of all products granted a marketing authorisation after 30 October 2005. This includes, for example, products that are administered only by healthcare professionals. It may also apply to variations introducing major changes to the package leaflet. In some circumstances, it is possible to submit a ‘justification' for not testing a particular leaflet in your portfolio, for example if it is very similar to another product already tested. There are also solutions where a full test is not required and 'focused testing' is acceptable. All existing UK leaflets had to be User Tested by July 2008.

Other EU health authority requirements

It is likely that the rest of Europe will follow the MHRA requirements with the need for User Testing of product leaflets of existing products over the next few years. Some authorities have already given deadlines for this excercise, they are:

• Belgian deadline is 2012
• Irish deadline is 2010
• Germany User Testing is voluntary, but strongly recommended.

You may have products that are not on the market in the UK, but are elsewhere in Europe – will this affect you?

Our experience can help you

At Cambridge Regulatory Services, we combine years of experience gained in writing package leaflets as part of our core business with more recent experience in User testing procedures. CambReg’s User Testing team has completed more than 200 full User Tests and over 400 bridging reports over the last 2 years alone, working across all sectors of the pharma industry. Our dynamic approach to bridging strategies for whole product portfolios has proven to be very successful and has significantly reduced the overall costs of this process for our clients.

Examples of typical projects:

• Full User Test on a product with a novel route of administration, going through
  the Centralised Procedure.
• A portfolio from a generics company based in mainland Europe going through MRP with very short timescales.
• User Testing for a regulatory consultancy on behalf of their client.
• A range of full User Tests and bridging studies for a generics company,
  who delegated to us complete responsibility for the rewriting of their Package Leaflets, creation of the mock-ups, the User Tests and the final reports.
• User Testing an entire portfolio from a company with a range of
  respiratory and cardiovascular products after we had completed a ‘trial' test.
• Reviewing the entire portfolio of leaflets and advising on strategy for user testing in order to minimise the number of tests required.
• ‘One-off' User Tests in a short timescale with minimal client involvement.
• User Testing a range of anti-fungal and antibiotic products for self-administration and administration by health professionals only.

To request further information on our services please email info@cambreg.co.uk or go to our contact page.

*References
1. Council Directive 2001 83 EC: Guidance concerning consultations with target patient groups for the package leaflet.
2. Guideline on the readability of the label and package leaflet of medicinal products for human use (Revision 1, Jan 2009).
3. EU Guidance concerning consultations with target patient groups for the package leaflet (May 06).
4. Questions and Answers to support the MHRA Guidance on User Testing (June 05).
5. Guidance for the Pharmaceutical Industry on the use of Bridging Studies to demonstrate compliance with article 59(3) of Council Directive 2001/83/EC) [Consultation with Target Patient Groups] (Dec 06)
6. Further guidance on designing Patient Information Leaflets and how to achieve success in User Testing (Mar 07)