The ICH S5(R3) Guideline on Detection of Toxicity to Reproductions for Human Pharmaceuticals reached Step 4 of the ICH Process in February 2020.

Infanrix-IPV+Hib DE/W/0036/pdWS/006 End of Procedure: 08/11/2016 Date of Publication: 23/02/2017 DE/W/0036/pdWS/008 End of Procedure: 26/11/2019 Date of Publication: 14/02/2020 DE/W/0036/pdWS/009 End of Procedure: 13/12/2023 Date of Publication: 28/02/2024

In November 2019, the ICH Assembly met in Singapore for its bi-annual meeting.

In November 2019, the ICH Management Committee met in Singapore for their bi-annual meeting.

The ICH M9 Guideline and Q&As on Biopharmaceutics Classification System (BCS)-based biowaivers reached Step 4 of the ICH Process

The ICH Q12 Guideline on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management and its Annexes reached Step 4 of the ICH Process

The ICH E9(R1) Addendum to Defining the Appropriate Estimand for a Clinical Trial/Sensitivity Analyses reached Step 4 of the ICH Process

The International Council for Harmonisation (ICH) met in Singapore from 16 – 20 November 2019, bringing together over 450 participants from ICH’s sixteen Members and thirty-two Observers.

Monitoring the progress of international harmonisation and coordinating efforts in this regard is an important ICH focus.

In October 2018, further to a discrepancy raised regarding the Permissible Daily Exposure (PDE) for ethyleneglycol, an error correction procedure was launched...