On Thursday, 31 October 2019, as part of the GCP renovation plan, ICH held a public meeting entitled “ICH Global Meeting on E8(R1) Guideline on General Considerations for Clinical Trials” hosted by FDA, United States at their headquarters in Silver Spring, MD, USA.
The ICH Q12 Guideline on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management reached Step 4...
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.