Russian Ministry of Health considers using unregistered Russian-made drugs

| By | Drug Registration, Ministry of Health Care

Russian citizens may be allowed to receive free medical treatment with unregistered drugs. The initiative was submitted to the Ministry of Health by representatives of medical and pharmaceutical industry. This was announced by Dmitry Morozov, the President of Biocad, an innovative pharmaceutical company, and one of the authors of initiative.

The manufacturers believe that Russian patients should be allowed to use the innovative drugs that already passed all required studies, but have not yet been registered in the system of medicinal products of the Russian Federation. A source close to the Ministry of Health confirmed that the idea is already being worked out.

Currently, the law allows only foreign manufacturers to import unregistered medicinal products to Russia for early availability, while the Russian companies have no such opportunity.

A representative of the Ministry of Health noted that permission to import unregistered drugs to Russia is issued by the Ministry within a shortest period not exceeding five days. In addition, it should be noted that Russia established one of the shortest periods in the international practice for the expert examination of medicinal product in order to assess its quality, effectiveness and risk/benefit ratio. This period is 110 working days (about five months), added the representative of the Ministry. He also said that the acceleration of procedure for drug registration bears certain risks.

GMP news
Pharmaceutical industry News and events. Technology transfer and contract manufacturing of medicines.