Finishing line in sight for ICH reforms
This article was originally published in SRA
Executive Summary
Up to four more medicines regulators and two additional pharmaceutical industry bodies have expressed an interest in joining the reformed International Conference on Harmonisation when it begins operating later this year*.
You may also be interested in...
Brazil/South Korea Move To ICH Driving Seat Raises Global Harmonization Expectations
Brazil and South Korea have been accepted as new regulatory members of the International Council for Harmonisation. This has raised expectations that ICH guidelines will gain full acceptance in both countries, making it easier for the global innovative pharmaceutical industry to market their products there.
EU Accelerated Assessment Tracker
Marinus’s ganaxolone has lost its accelerated assessment status mid-review at the European Medicines Agency while Roche’s glofitamab will be fast-tracked once a filing has been made.
EU Accelerated Assessment Tracker
The EU filing for AstraZeneca’s nirsevimab is being reviewed under the accelerated pathway at the European Medicines Agency. Also, Janssen should know by now whether its planned filing for Zejula plus Zytiga will get the same treatment – as should SIFI for its planned Akantior filing.