Fragmin (dalteparin sodium) UK/W/0112/pdWS/001 End of procedure: 31/10/2019 Date of publication: 06/04/2020 SI/W/0008/pdWS/001 End of procedure: 20/06/2023 Date of publication: 28/07/2023

The coronavirus (COVID-19) pandemic has prompted an urgent need for a harmonised, standardised approach to coding and reporting the infection as a global health issue.

The ICH Q3C(R8) draft Guideline on Impurities: Guideline for Residual Solvents, revised to include the Permitted Daily Exposure (PDE) levels for 2-Methyltetrahydrofuran,...

The ICH biannual meeting, scheduled to be held in Vancouver in May 2020, is cancelled.

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...