Russia may foster import of drugs with EU, US registration

MOSCOW, Jan 15 (PRIME) -- Federal Antimonopoly Service Head Igor Artemyev has suggested to Prime Minister Dmitry Medvedev that Russia abandon compulsory clinical examination of the drugs, which are registered in the E.U. and the U.S., according to Artemyev’s letter to Medvedev, seen by PRIME on Friday.

The antitrust wants to review clinical research conducted by the U.S. Food and Drug Administration (FDA) and The European Medicines Agency (EMA) to estimate quality and safety of medicines.

At present, the compulsory procedure halts export of new drugs to Russia and some pharmaceutical companies do no research in the country because testing may last for one year or more.

“Russian legislation sets sufficient time -- 160 days for public registration of medicines, including 110 days for examination of reports on clinical studies. This period, 110 days, is enough for an examining organization to review reports on clinical research of drugs, registered by the FDA or the EMA,” Artemyev said.

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