Showing XXX results across 3 categories.
Monitoring the progress of international harmonisation and coordinating efforts in this regard is an important ICH focus.
Further to the ICH Q13 draft document reaching Step 2b of the ICH Process, the Step 2 Informational Presentation developed by the ICH Q13 EWG has been finalised.
The ICH Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products reached Step 2 of the ICH process on 27 July 2021 and now enters the public consultation period.
At DIA’s Global Annual Meeting on 28 June, 2021, DIA announced that it was awarding ICH the 2021 Award for Outstanding Contribution to Health.
The information paper explains the current situation about the International Organization for Standardization (ISO) standards related to the identification of medicinal products (IDMP) that are used in E2B(R3) messages (as of 16 February 2021).
Further to the ICH S12 draft document reaching Step 2b of the ICH Process, the Step 2 Informational Presentation developed by the ICH S12 EWG has been finalised.
The International Council for Harmonisation (ICH) met virtually on 2-3 June 2021 in place of face-to-face meetings that were to take place in Incheon, Republic of Korea. The meeting was preceded by virtual meetings of the ICH Management Committee and MedDRA Management Committee.
The ICH S1B(R1) draft Guideline reached Step 2 of the ICH process on 10 May 2021.