Documents

This page shows a list of all current documents made available by IGDRP, and links to download them.

Name Uploaded File type Sizesort descending Download link
Common ASMF_DMF Submission Form - Word ver 1.3.docx 13 Dec 2016 docx 34.84 KB Download
IGDRP Membership Application form.docx 19 Jul 2017 docx 60.56 KB Download
Expression of Interest (EOI) Request to participate in the Information Sharing Pilot for the Evaluation of Generic Drug Applications involving the Centralised Procedure of the European Union.docx 21 Apr 2015 docx 74.53 KB Download
Summary of Quality Differences.docx 21 Apr 2015 docx 82.12 KB Download
IGDRP BCS Biowaiver Assessment Report template - Word version 1.docx 28 Feb 2017 docx 84.18 KB Download
IGDRP Roadmap to 2020.pdf 21 Dec 2016 pdf 133.79 KB Download
IGDRP ASMF_DMF QAR template - ver. 2.0 (2017-06-07, final).docx 25 Jul 2017 docx 135.51 KB Download
International Generic Drug Regulators Programme (IGDRP) Information Sharing Pilot.pdf 21 Apr 2015 pdf 156.52 KB Download
Common ASMF_DMF Submission Form.pdf 01 Apr 2016 pdf 231.86 KB Download
Expression Of Interest (EOI)_Request_Form to Participate in the Fisrt Information Sharing Pilot for the Evaluation of Generic Drug Applications involving the Decentralised Procedure of the European Union.pdf 12 Aug 2015 pdf 263.55 KB Download
IGDRP ASMF_DMF QAR template - ver. 2.0 (2017-06-07, final).pdf 25 Jul 2017 pdf 281.99 KB Download
IGDRP Terms of Reference (updated 9 June 2017).pdf 18 Jul 2017 pdf 282.29 KB Download
IGDRP ASMF_DMF WG Lexicon of Quality Terms.pdf 08 Mar 2016 pdf 321.66 KB Download
Guidance for Quality Assessors-Drug Substance (ver 1.0).pdf 28 Nov 2017 pdf 605.43 KB Download
Proposed common criteria for issuing a new ASMF - PDF (Version 1.0).pdf 17 Jul 2017 pdf 606.05 KB Download
IGDRP BCS Biowaiver Assessment Report template -PDF - version 1.pdf 28 Feb 2017 pdf 688.68 KB Download
IGDRP-Health Canada-CAPRA Symposium - Agenda (June 9, 2017).pdf 19 May 2017 pdf 765.28 KB Download