Meeting with the Medicines and Medical Devices Agency
On June 19, AmCham Healthcare Committee met with the Deputy Director of the Medicines and Medical Devices Agency, to discuss the causes for recent blockages in the fast-track mechanism for state authorization of medicines. The parties have agreed to organize a further technical meeting, on July 20, in order to start the work on regulatory improvement, focusing on such issues as acceptable differences between the registration files submitted in EU and Moldova, as well as obligations derived from the lack of national electronic archives for authorization procedures prior to 2013.
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