It is proposed that medicines which have not undergone clinical trials in Russia should be admitted to the domestic pharmaceutical market. This applies to drugs from the European Union, the USA and Japan. The Ministry of Industry and Trade explained to Izvestia that the issue may be settled at the level of intergovernmental agreements. The measure will help speed up patients' access to new medicines, including those for cancer patients. Such medicines are planned to be labeled with a warning inscription that the drug has not undergone clinical trials in Russia. Currently, it takes up to five years to bring a new drug to the market, experts say.
The plans to develop a mechanism for the admission of original drugs to the Russian market are set out in the "road map" "Development of Competition in Healthcare" approved by the government. As stated in the document, it concerns medicines that have undergone clinical trials in the European Union, the USA or Japan. By January 2019, the Ministry of Health should submit to the government the mechanisms for implementing the idea. FAS and the Ministry of Industry and Trade will also take part in the work.
The plans to develop a mechanism for the admission of original drugs to the Russian market are set out in the "road map" "Development of Competition in Healthcare" approved by the government. As stated in the document, it concerns medicines that have undergone clinical trials in the European Union, the USA or Japan. By January 2019, the Ministry of Health should submit to the government the mechanisms for implementing the idea. FAS and the Ministry of Industry and Trade will also take part in the work.
The issue of admitting imported drugs to the domestic market without clinical trials in Russia may be regulated at the level of intergovernmental agreements, the Ministry of Industry and Trade told Izvestia. At the same time, the requirements for conducting trials should be reciprocal, i.e. agreed between the states, the ministry said.
The issue of admitting imported drugs to the domestic market without clinical trials in Russia may be regulated at the level of intergovernmental agreements, the Ministry of Industry and Trade told Izvestia. At the same time, the requirements for conducting trials should be reciprocal, i.e. agreed between the states, the ministry said.