ASMF/DMF Quality Assessment Report (QAR) Template (version 2.0, finalised June 2017)

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The sharing of common ASMF/DMF assessment reports among ASMF/DMF Working Group members supports the broader goal of the IGDRP to promote collaboration among generic drug regulators and regulatory convergence of technical requirements.

The use and the value of a shared assessment report can be increased if the presentation and placement of assessment information follows a consistent format – such as a Quality Assessment Report (QAR) template. Furthermore, the ASMF/DMF QAR template has the ability to promote regulatory convergence through a series of agreed prompts to be considered throughout the assessment of the technical information contained in an ASMF/DMF. Therefore, the IGDRP Quality Working Group (QWG) has developed a Quality Assessment Report template for the Common Technical Document (CTD) Module 3.2.S for use by QWG members.

The ASMF/DMF QAR template was originally finalised in May 2015 (version 1.0) and has since undergone a maintenance process. Revisions have been incorporated into the updated version of the QAR template based on experience gained and to include other enhancements to facilitate its use. The updated version (version 2.0) and has been finalised in June 2017. 

The use of this template, in whole or in part, by IGDRP members is not mandatory. Each IGDRP member 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 IGDRP member may for practical reasons choose to revise the format or written language of a model document.

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

The ASMF/DMF QAR template is published in both PDF and Woed versions:

Quality Assessment Report (QAR) template (PDF version 2.0)/

Quality Assessment Report (QAR) template (Word ver 2.0)