Ectd
Found 5 free book(s)ICH M2 EWG - ESTRI
estri.ich.orgich ectd specification v 3.2. 2 16-july-2008 international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use
EU Module 1 eCTD Specification - Europa
esubmission.ema.europa.eu2 Document Control Change Record Version Date Author(s) Comments 0.1 July, 2001 Stan van Belkum Draft 0.2 September, 2001 Stan van Belkum Draft
CTD: Revisions to the M4 Granularity Document
www.ich.org1/23/2017 7 13 Table 2: Module 3 (paper & eCTD v3.2.2) • R3 Revision (2004) o P.4 Control of Excipients documents, can be rolled-up into a single P.4 document, but still may be submitted at the lower P.4.x level if needed • R4 Revision (2016) o P.4.x documents can be rolled-up into a single P.4 document
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
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