Drug Regulators EMEA Publish Q&A on ICH M2 – Common Technical Document for the Registration of Pharmaceuticals for Human Use
This question and answer document is a summary of questions reviewed by the eCTD Implementation Working Group (IWG) on the eCTD Specification. The questions answered here relate to common questions that relate to the eCTD in all three ICH regions. Many of the questions received on the Step 2 specification were addressed in Step 4 and do not appear in the list. Questions concerning the timeframe for implementation of region-specific application types, module 1 implementation, lifecycle management and those questions that relate to items in the specification that direct the reader to each region are answered in guidance documents published for each region.
Questions related to the table of contents for the Common Technical Document (CTD) should be directed to the CTD question and answer section of the ICH Website.
Some of the questions posed so far address change requests to the eCTD Specification. The change request section of this document addresses all those items received by the eCTD IWG and indicates their status.
This document will be updated as the specification undergoes change control or as new questions are submitted to the eCTD IWG.
It is available on the EMEA website, or email me asking for 082003en and I will send you a copy.
If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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