San Diego Finance

Sep 30 2017

Public Consultations: ICH #it #consultation


Public Consultations

You are invited to provide comments on any of the draft ( Step 2b ) Guidelines (see list below for current consultations) by e-mailing the ICH Secretariat.

You are also very welcome to send questions and comments concerning the implementation of the ICH Guidelines (see list below for current Implementation Working Group (IWG)). Indeed, the ICH Assembly establishes IWGs to assist in Guideline implementation, as needed. Such additional implementation guidance/advice is usually developed in the form of Questions and Answers (Q As). Note that stakeholders from ICH regions are encouraged to submit their comments to their respective Regulatory Authorities.

Draft Step 2b Guideline currently undergoing public consultation:


Questions Answers: Selection and justification of starting materials for the manufacture of drug substances

This Question and Answer Document is proposed to provide additional clarification and to promote convergence on the considerations for the selection and justification of starting materials and on the information that should be provided in marketing authorisation applications and/or Master Files. The focus of the Q A document is on chemical entity drug substances.

Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population

This Addendum is proposed to address new scientific and technical knowledge advances in pediatric drug development such as targeted scientific and technical issues relevant to pediatric populations, regulatory requirements for pediatric study plans, as well as infrastructures for undertaking complex trials in pediatric patient populations.

Deadline for comments.

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