ASMF/DMF Quality Assessment Report (QAR) Template (version 1.2, finalised May 2015)

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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 ASMF/DMF working group has developed a model Quality Assessment Report for the Common Technical Document (CTD) module 3.2.S for use by ASMF/DMF working group members.

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.

Quality Assessment Report (QAR) template (PDF version 1.2)

The following word version is provided as supplemental to the PDF version above.  Non-IGDRP member regulators may implement these documents within their own responsibility. IGDRP is not responsible for any contents of these documents implemented by non-IGDRP member authorities.

Quality Assessment Report (QAR) template (Word ver 1.2)