Transcription of CTD: Revisions to the M4 Granularity Document
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CTD: Revisions to the M4 Granularity Document
1/23/201711 CTD: Revisions to the M4 Granularity DocumentCTD Quality Implementation Working GroupInternational Council for Harmonisation of Technical Requirementsfor Pharmaceuticals for Human UseLegal Notice This presentation is protected by copyright and may be used,reproduced, incorporatedinto other works, adapted, modified, translated or distributed under a public licenseprovided that ICH's copyright in the presentation is acknowledged at all times. In case ofany adaption, modification or translation of the presentation, reasonable steps must betaken to clearly label, demarcate or otherwise identify that changes were made to orbased on the original presentation. Any impression that theadaption, modification ortranslation of the original presentation is endorsed or sponsored by the ICH must beavoided. The presentation is provided "as is" without warranty of anykind.
1/23/2017 4 7 Remit of the CTD-Q IWG* • Address the eCTD Change Request for the placement of “Control Strategy” ( eCTD Q&A #81) • Revise the M4 “ANNEX : Granularity Document”: o Version 3.2.2 (extant) o Version 4 (aka, v4, Regulated Product Submission, Next Major Version [NMV]) • Provide input on v4 “keywords” and revisions to v3 XML-attributes**
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