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
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
- Working Group Webpage
- E14/S7B Draft Q&As (Aug 2020)
- E14/S7B Work Plan (Apr 2020)
- E14/S7B Concept Paper (Nov 2018)
Original ICH E14 and S7B Guidelines and Existing E14 Q&As
- E14 Guideline (May 2005)
- S7B Guideline (May 2005)
- E14 Q&As (R3) (May 2015)
