The International Conference on Harmonisation (ICH) is the most significant organisation for the harmonisation of requirements with regard to the authorisation and the manufacture of medicinal products. The ICH wants this function to be extended. For that reason - during the last meeting in Minneapolis, USA - the Steering Committee decided to welcome two new members. Beside the American FDA, the EMA/EU Commission and the Japanese Authority belong to the founding members. Now, the Swiss Authority Swissmedic and the Canadian one (Health Canada) have joined the ICH Board.
Another important notice has been announced after the meeting in Minneapolis. In September 2014, the harmonised Guideline ICH Q3D Elemental Impurities will reach the Step 4 status. The FDA as well as the EMA/EU Commission and the Japanese MHLW will take over the whole document into their respective national regulations. This last – and formal – procedure will be defined as Step 5. No changes will be made in the guidance document when the authorities will make the transfer to the regulatory framework.
The new ICH Q3D and the recently adopted ICH M7 (Genotoxic Impurities) will therefore be addressed at the international Impurities Forum in Berlin.