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Main  >  News  >  The Ministry of Health of the Russian Federation supports the practice of accelerated launch of drugs on the market

The Ministry of Health of the Russian Federation supports the practice of accelerated launch of drugs on the market

The Ministry of Health of Russia supports the spread of the practice of accelerated launch of drugs on the Russian market. This is reported by TASS with reference to the press service of the Ministry of Health.

In the State Duma, in the autumn session, they plan to prepare a bill to speed up the process of registering new drugs in Russia. This was previously reported by Vedomosti, referring to Alexander Petrov, a member of the Duma Committee on Health Protection.

As noted in the ministry, now there is an opportunity to accelerate the launch of Russian original medicines (MP) on the market thanks to the decision of the Council of the Eurasian Economic Commission (EEC), which made a change to the rules for registration and examination of medicines for medical use.

The rules provide for accelerated and conditional registration of a medicinal product, including in exceptional cases, with the establishment of additional post-registration requirements (implementation of a risk management plan, post-registration studies of safety and various aspects of the effectiveness of a medicinal product that cannot be studied prior to its implementation).

“For certain categories of medicines (for the treatment of serious disabling or life-threatening diseases, orphan medicines), in order to provide patients with the necessary medicines and protect the interests of the health of citizens, registration may be required based on data that is less complete than usual, but subject to established special obligations, ”the press service of the Ministry of Health of the Russian Federation quotes the publication.

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