The State Expert Center for Registration of Medicines of the Ukrainian Ministry of Health gave a positive opinion on the registration of the first drug under a new simplified procedure. The information was published on the website of the Center.
According to the report, “the medicine manufactured by Amaxa Pharma received a positive opinion from the State Expert Center for registration under a new simplified procedure in accordance with the Order of the Ministry of Health No. 1245. The procedure is intended for registering in Ukraine within 17 days the innovative drugs, which have already been registered in the USA, Canada, Australia, Switzerland, Japan, and the European Union (by European Medicines Agency).”
Today, this is the only drug that will be registered under a simplified procedure according to the decision of the Ukrainian Ministry of Health based on the positive opinion of the Center.
In addition to this application, the Expert Center received applications from two other manufacturers, which have been rejected.
In Ukraine, the registration of medicines is carried out under the general procedure within 210 days; and under the shortened procedure, the registration can be carried out within 45, 17 or 10 days, depending on the category of registered drugs.