Tag Archives: ICH M2

EMA Announce Information day on ICH, M5 & M2 Electronic Submission of Product Information

Posted on September 12, 2011 by admin| Leave a comment

EMA Announce Information day on ICH, M5 & M2 Electronic Submission of Product Information

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The European Medicines Agency is organising this public-awareness event to inform attendees about the electronic submission of medicinal product information in line with the provisions set out in the new pharmacovigilance legislation and the five identification of medicinal product standards under finalisation by the International Organization of Standardization. Registration open until 15/09/2011. Places limited.


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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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EMA Publish ICH M2 Guideline, Busines Requirements

Posted on October 25, 2010 by admin| Leave a comment

EMA Publish ICH M2 Guideline, Business Requirements

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ICH M2 has initiated the development of the Next Major Version of the eCTD (eCTD NMV) to improve robustness, flexibility and long term stability of the message. In accordance with the decision by the ICH Steering Committee that technical specifications should no longer be developed solely within ICH, but should be created in collaboration with Standards Development Organisations (SDOs), the eCTD NMV will be developed jointly with the HL7 RPS project. M2 has developed the following list of requirements as input into the HL7 RPS Project.

For Assistance with Regulators Click Here

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.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

Fill Out the Short Form Below…


  1. (required)


  3. (valid email required)

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

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Drug Regulators, EMEA, Publish ICH M2, Common Technical Document, Updated Q&A

Posted on December 26, 2009 by admin| 1 Comment

Drug Regulators, EMEA, Publish ICH M2, Common Technical Document, Updated Q&A

Full text is an excell spreadsheet, its available from me on request. damien.bove@idaconsultants.com or on the EMEA website.

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.

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.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free.

As you know this website is a great resource for keeping up to date with developments and regulations, why not get our FREE monthly regulatory and market round up. You can un-subscribe at any time and we do not share your details with anybody.

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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

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Drug Regulators Publish, ICH M2, Business Requirements Guidance

Posted on December 25, 2009 by admin| Leave a comment

Drug Regulators Publish, ICH M2, Business Requirements Guidance.

Full Text Here

ICH M2 has initiated the development of the Next Major Version of the eCTD (eCTD NMV) to improve robustness, flexibility and long term stability of the message. In accordance with the decision by the ICH Steering Committee that technical specifications should no longer be developed solely within ICH, but should be created in collaboration with Standards Development Organisations (SDOs), the eCTD NMV will be developed jointly with the HL7 RPS project. M2 has developed the following list of requirements as input into the HL7 RPS Project.
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.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free.

As you know this website is a great resource for keeping up to date with developments and regulations, why not get our FREE monthly regulatory and market round up. You can un-subscribe at any time and we do not share your details with anybody.

First name

E-mail address

This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Drug Regulators Publish, ICH M2, Business Requirements Guidance

ida 100programme 515x64 LowRes Drug Regulators Publish, ICH M2, Business Requirements Guidance

Turn your Business Into an Investor Magnet

How to Write a Business Plan – Free E-Course

Get the secrets that turns your project into an investment magnet, 100% of our clients raise the finance they need to take their projects to the next stage, we will share these secrets with you. – Sign up for Free

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

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Drug Regulators, EMEA, Publishes Q&A on ICH M2 eCTD

Posted on July 18, 2009 by admin| Leave a comment

The Drug Regulators, EMEA, has published Q&A paper on ICH M2

The EMEA publishes ICH Topic M 2 Question and Answer Common Technical Document for the Registration of Pharmaceuticals for Human Use

Its a huge document that I would recommend you reading as its too big and varied to summarise here, but the document reference so you can search for it is CPMP/ICH/820/03.

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.

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.

ida consultants freestrategyconsultation 515x64 Drug Regulators, EMEA, Publishes Q&A on ICH M2 eCTD

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As you know this website is a great resource for keeping up to date with developments and regulations, why not get our FREE monthly regulatory and market round up. You can un-subscribe at any time and we do not share your details with anybody.

This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.

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