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: