Transcription of EU Module 1 eCTD Specification
{{id}} {{{paragraph}}}
Example: air traffic controller
EU Module 1 eCTD Specification
EU Module 1 ectd Specification Version 1 May 2016 2 Document Control Change Record Version Date Author(s) Comments July, 2001 Stan van Belkum Draft September, 2001 Stan van Belkum Draft October, 2001 Stan van Belkum Draft November, 2001 Stan van Belkum Draft February, 2002 Stan van Belkum Draft February, 2002 Stan van Belkum Draft March, 2002 Stan van Belkum Draft October, 2002 Stan van Belkum Draft November, 2002 Stan van Belkum Draft February, 2003 Stan van Belkum Draft July, 2003 Stan van Belkum Draft February 2004 M. Bley Draft May 2004 EMEA Draft 28 May 2004 EMEA Draft 23 June 2004 EMEA Draft July 2004 EMEA Final December 2005 EMEA Integration of PIM May 2006 EMEA Structural changes from CTD October 2006 EMEA Alignment to CTD and Change Requests May 2008 EMEA Incorporation of paediatric requirements and Change Requests August 2009 EMEA Alignment to the New Variation Regulation and Change Requests November 2011 EMA Incorporation of Additional Change Requests and Q&A December 2012 EMA New Draft version including proposed DTD changes as requested by: CR 20120924 rev CR 20121119 CR 20091203 CR 20100408 CR 20101022-01 CR 20101214 CR 20110614 17 December 2012 EFPIA EFPIA changes, added PDF , , edited file allowed formats, added common for CP, adjustments to agency codes
eCTD specification (ICH and EU) will be described using metadata as defined by the EU envelope. Sequences may be related to one another within one regulatory activity. The related sequence number should always be stated. In case of activities with only one sequence the same sequence number will be used.
Loading..
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: