Ectd guidance document
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eCTD Guidance Document - Europa
esubmission.ema.europa.euGuidance for Industry on Providing Regulatory Information in Electronic Format: eCTD Version: 2.0, August 2011 3 (46) 1. INTRODUCTION . This guidance document is intended to assist pharmaceutical companies with the submission of regulatory
eCTD Guidance Document - Europa
esubmission.ema.europa.euThis guidance document is intended to assist pharmaceutical companies with the submission of regulatory information in electronic Common Technical Document format (eCTD) to the National Competent Authorities
CTD: Revisions to the M4 Granularity Document
www.ich.org1/23/2017 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”:
ICH M2 EWG - International Council for …
estri.ich.orgICH eCTD Specification V 3.2.2 16-July-2008 Document Change History Version Number Date Description Version 3.0 October 2003 Initial Step 4 Document
ACTIVE PHARMACEUTICAL INGREDIENTS …
apic.cefic.orgAPIC_eCTD How to Do Page 6 Requirements for electronic files Electronic files should be in accordance with the Guidance for Industry on Providing Regulatory
MEDICINES CONTROL COUNCIL - mccza.com
www.mccza.comRegistration of Medicines eCTD Submission in South Africa . 2.23_Submission_in_eCTD_format_Sept16_v2.1 Page April 2017. 1 of 26. MEDICINES CONTROL COUNCIL
ICH M2 EWG - ESTRI
estri.ich.orgich ectd stf specification v 2.6.1 3-june-2008 international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use