According to the Russian Ministry of Industry and Trade, this institution has prepared the draft law “On Amendments to the Federal Law On Circulation of Medicines”, intending to reduce time required for foreign medicines to enter the Russian market.
Sergey Shulyak, the head of DSM Group, a marketing company, said that, today, a new drug has to undergo many procedures and expert examinations before it becomes available to the consumers. As for the new developments or already existing products, they have to pass through repeated studies in Russia. This is because the Russian Ministry of Health does not accept the results of studies from other countries. According to Ivan Glushkov, the deputy director of a pharmaceutical holding company, upon completion of all studies, the company, that is a drug developer, must submit documents to obtain the declaration of conformity of the medicine to the quality standards.
After submitting documents for the declaration of conformity to the quality standards for each lot (10-80 thousand packages depending on the specific drug strength and medical device), the companies receive the certificate of conformity. It is issued by the accredited laboratories. In addition, when it comes to the foreign manufacturer of drugs, the representatives of the Russian Ministry of Health must visit the plant where that medicine is produced or scheduled for manufacturing.
The Ministry of Industry and Trade proposed to eliminate some excessive regulations. For example, it wants to combine the procedure of expert examination of the drug at its registration and re-registration with the procedure of inspecting the foreign facility, from which that medicine will be supplied.
“In addition, the draft proposes to allow the contract manufacturing of drugs, when a foreign or Russian company without its own production capacity may hire a manufacturer with the valid license and experience for manufacturing the drug in Russia,” said a representative of the Ministry of Industry and Trade. “This is important in terms of ensuring the optimal load of existing production capacities.”