Russia has one of shortest periods for introducing foreign drugs onto the market

The recognition of foreign drug certificates in Russia should be based on the principles of reciprocity. This was announced by Elena Maksimkina, the Head of the Department of Drug Supply and Regulation of Medical Devices at the Ministry of Health of the Russian Federation, who spoke on May 26 on the sidelines of the St. Petersburg International Economic Forum.

Earlier, Russian President Vladimir Putin said at the plenary session of the Forum that the registration of drugs in Russia is very bureaucratic. He suggested that the Ministry of Health should perform feasibility study of recognizing foreign certificates for medicinal products.

“We are subject not only to domestic rules, but also the rules in the Eurasian Union. And everyone in the Eurasian Union acknowledges that the recognition [of foreign certificates for medicinal products] should be mutual,” said Ms. Maksimkina.

She added that such recognition already exists for groups of drugs related to rare diseases.

“There is nothing that prevents us from [signing] bilateral agreements that would allow to introduce the drugs to the market more quickly, but this should be based on the principles of reciprocity – you recognize our product when we introduce yours. We are also interested in exports,” added Ms. Maksimkina.

Certificates of Russian medicines are re-verified abroad while, in her words, Russian Federation has “one of shortest periods” for introducing foreign drugs to the market. Ms. Maksimkina said that, sometimes, the delay in the introduction of foreign drug onto the Russian market is caused by the applicant.

“Probably, it would be right if we establish a fully public and open procedure. Sometimes, it really happens through the fault of the applicant,” she said.