A Bridging Report is prepared during “bridging”, which can be applied in a situation where two (or more) leaflets are sufficiently similar in terms of the content and the layout.
In such case there is no necessity to conduct the Package Leaflet Readability Test for each leaflet separately – a successful user consultation on one leaflet (“parent” leaflet) can be used to demonstrate that the other (“daughter” leaflet) is legible and meets the requirement of Art. 59(3) of Directive 2001/83/EC.
The Bridging Report includes a detailed comparison of the content of the “parent” leaflet with the “daughter” leaflet in terms of visual and substantial, what provides the basis for deciding whether, in a particular case, a successful user test on the “parent” leaflet can be used to support a justification for not testing other similar leaflets (“daughter” leaflets).
For more information regarding leaflet readability test conduction please refer to the link.
Package Leaflet Readability Test conduction and its submission is obligatory, for example, when MAH wants to obtain Marketing Authorisation for the medicinal product. When the product has more than one strength and/or pharmaceutical form, use of bridging significantly reduce the time spent on Readability Test conduction. Then it is possible to perform a Readability Test for only one strength and/or pharmaceutical form and submit a Bridging Report for the others.
Please note that if you find too many differences between PL “parent” and “daughter” in terms of content – simultaneously with the Bridging Report, you can submit a report from focused test in addition to addressing 1 or 2 points different from the “parent” PL.
In addition, it is also acceptable for bridging to use two “parent” leaflets (Multiple Bridging). Such a solution is used, for example, when the text of the “daughter” leaflet is similar to the “parent” leaflet in terms of content, whereas they differ in terms of the visual presentation of information. Then the design of “daughter” leaflet is bridged to the other “parent” leaflet. This results in two Bridging Reports that are submitted simultaneously.
Let us help you decide which solution is best for your situation.
As mentioned previously, the Bridging Report contains a detailed discussion of the factual similarities between the “parent” leaflet and the “daughter” leaflet in terms of visual and substantial content, including, in particular, the demonstration of the similarity of key safety information. For each medicine these messages will be different although, the leaflet will cover the same sort of information in the same manner. The purpose of a well prepared Report is providing evidence that these messages can be found and understood, so that the medicine can be used safely.
Another particularly important aspect of completing the Bridging Report is to identify the appropriate grounds for bridging based on a solid justification. Therefore, a professional verification of Package Leaflets in terms of the possibility for bridging use in accordance with EU guidelines is demanded. Undoubtedly, for this purpose, it is worth looking at such guidelines as:“Guideline on the readability of the labelling and package leaflet of medicinal products for human use” and “Consultation with target patient groups -meeting the requirements of Article 59(3) without the need for a full test -recommendations for bridging”.
According to CMDh guidelines, important aspects that are compared during bridging are: font and text size, headings and sub-headings (including consistency of placement), PL dimensions (including whether the document is laid out in portrait or landscape format), use of colour and written language used, layout of critical safety sections of the PL, use of pictograms, paper weight.
The Bridging Report should always contain a solid justification and the grounds for bridging should be assessed on a case-by-case basis.
Our Regulatory Affairs Experts have an extensive experience in Bridging Reports and appropriate dossier preparation, verification and submission – all of submitted Bridging Reports prepared by SciencePharma have been approved by European Authorities.
Besides wide range of Regulatory Affairs services SciencePharma offers full support in remaining Modules dossier preparation and substantive problems solving.
SciencePharma takes care of full registration dossier preparation. Furthermore, SciencePharma has an extensive experience in Package Leaflet Readability Tests conduction and Bridging Reports preparation as well as in the field of Regulatory Affairs in national and European procedures (MRP, DCP, RUP).
Keeping abreast of the latest Competent Authorities requirements is much easier with the support of an experienced and well-informed team.
At SciencePharma, we offer:
Furthermore, we do have many years of experience with National, European and Centralised Procedures registration dossier submission, depending on the individual needs of the Marketing Authorization Holder.
If you are interested in working with us, please do not hesitate to contact us. Our Experts will answer all you questions and resolve doubts.