Biologicals [Track version] (February 2020, correction May 2024)

CMDh Best Practice Guide on the compilation of the dossier for New Applications submitted in Mutual Recognition and Decentralised Procedures (November 2025) [Track version]

The ICH M9 Guideline on Biopharmaceutics Classification System-based Biowaivers reached Step 4...

The ICH S5(R3) Guideline on Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals reached Step 4...

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.