QWG - Publication of Quality Assessment Report (QAR) – Full Dossier template

Submitted by n.leuba on Wed, 06/23/2021 - 09:17

The IPRP Quality Working Group (QWG) has developed the IPRP Quality Assessment Report (QAR) – Full Dossier template for the assessment of technical information contained in Common Technical Document (CTD) Module 3 for use by IPRP members and observers.


The sharing of Quality Assessment Reports (QARs) among IPRP members and observers supports the goal of the IPRP to promote efficiency and regulatory convergence by sharing best practices and developing tools as a resource for regulators to assist in the regulatory review of applications for marketing authorisation.


The finalisation of this template now completes the suite of IPRP Quality regulatory tools for the assessment of Quality information related to drug substances and drug products.


The template and more information can be found linked on the QAR page linked to on the QWG page.