The Working Group on creation of common approach to regulating market circulation of pharmaceuticals has approved a number of necessary documents. These documents are required for the launch of the common pharmaceuticals market in Eurasian Economic Union member states (Belarus, Kazakhstan, Russia, Armenia and Kyrgyzstan).
Currently, the main task of the Working Group is to develop the third document package for the pharmaceuticals market – the so-called “third level documents”.
The Working Group has reviewed the first edition of the Guideline for the preparation of dossier for non-investigational medicinal products for clinical trials and the Requirements for modified release preparations for oral administration. Also, the Working Group has reviewed Requirements for water used for medicines manufacture and the Guideline for validation of manufacturing processes of medicinal products. These draft documents have been approved for the publication on the official site of the Eurasian Economic Commission for public discussion.
The next meeting of the Working Group is planned in October 2016.