© РИА Томск. Яков Андреев
TOMSK, Nov 6 – RIA Tomsk. Siberian state medical university (SSMU) plans to obtain the international license which will allow the center of introduction of technologies created at Tomsk higher education institution to make pilot batches of pharmaceuticals for foreign companies in 2016, the head of the center Artem Guryev reported.
He specified that now the Tomsk center of introduction of technologies makes the small pilot batches of pharmaceuticals necessary for clinical tests for Russian companies. The center can't work yet with foreign enterprises as the license GMP is necessary for this purpose (Good Manufacturing Practice).
"We plan to submit the application for licensing. <…> Allegedly, it will be possible to obtain the license until the end of 2016, however the terms can be changed", – Guryev told.
© РИА Томск. Павел Стефанский
He noted that the license GMP is recognized in many countries of the world, and it will allow the center of SSMU to make drugs for the foreign pharmaceutical companies. However requirements to the enterprises, wishing to obtain the similar license in Russia, are uniform both for large industrial productions, and for small organizations.
"For example, there are requirements for big industrial warehouses. And such warehouses aren't necessary to us at all. But we are obliged to fulfill requirements to obtain the license. We offered the Ministry of Industry and Trade of the Russian Federation, which grants licenses, to reconsider such moments, but the problem isn't solved yet. <…> We are preparing for licensing according to the existing terms", – Guryev told.