ICH General Meeting approves Guideline E11(R1) and the questions and answers to Q11

13.09.17 - Following the ICH Meeting in Montreal on 27 May to 1 June 2017, the General Meeting has approved Guideline


  • E11(R1) “Clinical Investigation of Medicinal Products in the Pediatric Population”

and the questions and answers to


  • Q11 “Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)”

in Step 4 of the ICH process.

When guidelines are adopted by consensus within the ICH organisation (Step 4), they are regarded as harmonised and therefore as documents that reflect the current state of science and technology (see Swissmedic Journal 05/2006, p. 504).
As of publication on the ICH website, Swissmedic applies the addendum to the Guideline as well as the questions and answers to Q11 accordingly.

Link to publication on ICH website:

What is the ICH?
The objective of the "International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use" (ICH), founded in 1990, is to make recommendations towards achieving greater harmonisation in the interpretation and application of technical guidelines for the assessment and market authorisation of medicinal products for human use, thereby minimising duplication during development and the authorisation process. In October 2015 ICH reformed itself as a company under Swiss law with the new name of International Council for Harmonisation.
Further information can be found on the ICH website.