Generics
Generics (January 2026) [Track version]
Bupropion …
Bupropion NL/H/PSUFU/00000461/201812 Date of publication: 06/04/2020 PSUSA/00000461/201812 Date of publication: 17/12/2020
Fragmin (dalteparin sodium)…
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
Notification on MedDRA terms for coronavirus concepts now available
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 available now on the ICH website
The ICH Q3C(R8) draft Guideline on Impurities: Guideline for Residual Solvents, revised to include the Permitted Daily Exposure (PDE) levels for 2-Methyltetrahydrofuran,...
ICH Vancouver Meeting May 2020 Cancelled
The ICH biannual meeting, scheduled to be held in Vancouver in May 2020, is cancelled.
Biologicals
Biologicals [Track version] (February 2020, correction May 2024)
CMDh Best Practice Guide on the compilation of the dossier for New Applications submitted through the Mutual Recognition and Decentralised Procedures
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 introductory training presentation available now on the ICH website
The ICH M9 Guideline on Biopharmaceutics Classification System-based Biowaivers reached Step 4...
The ICH S5(R3) introductory training presentation available now on the ICH website
The ICH S5(R3) Guideline on Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals reached Step 4...