ICH E14/S7B Q&As: Public Comment Closes Soon!

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As a safety pharmacology leader, your voice matters!

The ICH E14/S7B Q&As are still open for comment in some regions, but not for much longer!

 

How Do I Submit my Comments?

Stakeholders from ICH Member countries/regions are encouraged to submit their comments to their respective Regulatory Authorities. Please note the deadlines for comments indicated below. Stakeholders can also provide their comments by e-mailing the ICH Secretariat at step2comments@ich.org

The US FDA direct link to comment can be found here. 

The EC Europe template to comment can be found here. The completed comments form should be sent to ich@ema.europa.eu 

Public consultation dates:

Health Canada, Canada - Deadline for comments by 23 November 2020
MHLW/PMDA, Japan - Deadline for comments by 25 November 2020
HSA, Singapore - Deadline for comments by 25 November 2020
EC, Europe - Deadline for comments by 28 November 2020
Swissmedic, Switzerland - Deadline for comments by 28 November 2020
NMPA, China - Deadline for comments by 30 November 2020
TFDA, Chinese Taipei - Deadline for comments by 30 November 2020

US FDA - Deadline for comments by 30 November 2020 

 

Rapporteur: Dr. David Strauss (FDA, United States)

Date of Step 2b: 27 August 2020; Status: Step 3

 

RESOURCES 

New Questions & Answers to ICH E14 and S7B

Original ICH E14 and S7B Guidelines and Existing E14 Q&As

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