Quality Assessment Report (QAR) – Full Dossier template


Quality Assessment Report (QAR) – Full Dossier template (Ver 1.0, finalised June 2021)


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 use and the value of sharing QARs can be increased if the presentation and placement of information relating to these assessments follow a consistent format, such as a common template and structure. Furthermore, using a common QAR template has the opportunity to promote regulatory convergence through a series of agreed prompts to be considered throughout the assessment the Quality information contained in applications. Therefore, 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 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, notably:

  • Guidance for Quality Assessors - Drug Substance;
  • Guidance for Quality Assessors - Drug Product;
  • Quality Assessment Report (QAR) template - ASMFs/DMFs;
  • Quality Assessment Report (QAR) template - Full Dossier.


The use of this IPRP QAR – Full Dossier template, in whole or in part, by IPRP members or observers is not mandatory. Each IPRP member or observer works within their own specific regulatory setting and some or all aspects of a document may, for a variety of reasons, not be applicable. Equally, a given IPRP member or observer may for practical reasons choose to revise the format or written language of a model document.


Non-IPRP member regulators may implement this document within their own responsibility. IPRP is not responsible for any contents of this document implemented by non-IPRP members.


The IPRP QAR – Full Dossier template is published in both PDF and Word versions.


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