The guidelines do not stipulate that all package inserts require readability user testing.
Bridging cuts costs and saves effort by referring to already successfully tested package inserts. This is suitable in the case of medicines:

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

We review your package inserts and create the bridging report in accordance with current guidelines:

  • 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: 21.02.2019

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