Bridging

According to the bridging guidelines, not every package insert requires readability user testing!

 

Why bridging?
Bridging is a cost and time-saving alternative to the legally required proof of readability via readability user testing. This is achieved by referring to previously successfully tested package inserts in the case of medicines:

  • of the same class of medicine
  • with an analogous safety profile and
  • analogous information presentation - layout and wording


Our bridging studies include:

  • evaluation of successful readability tests with regard to their suitability for reference
  • harmonisation of the package insert intended for bridging with the reference
  • analysis of the package insert related to content, language level and layout/design

 
We review your package inserts and create the bridging report in accordance with current guidelines,
such as the

  • CMDh guideline: "Consultation with target patient groups - meeting the requirements of article 59(3) without the need for a full test - recommendations for bridging ”, December 2017 (Rev.3) (PDF)
  • "QRD form for submission and assessment of user testing bridging proposals" -
    EMA/355722/2014 (Rev.1) (Word file) or CMDh/365/2017 (Rev.0) (Word file)


PAINT-Consult has carried out bridging procedures since 2006, long before the bridging guidelines were introduced. This includes every approval procedure - CP, DCP, MRP and national. 

Last update: 22.04.2019

  Contact
  +49 3641 549396