ARPM speaks about the necessity to expand the number of experts to discuss circulation of biomedical cellular products

A meeting of the sub- committee on issues of production, circulation, and import substitution of medical goods took place in the State Duma. The event brought together representatives of the Health Ministry, Ministry of Industry and Trade, and members of the CCI. Victor Dmitriev was representing the Association of the Russian Pharmaceutical Manufacturers.

Participants of the meeting discussed the new legislations of regulation of biomedical cellular products. Several Federal executive agencies have designed and passed a law on biomedical cellular products and developed good manufacturing practice of work with these products. The approved measures are to influence interest of investors, which are already prepared to invest in biomedical production in Russia.

According to Mr. Dmitriev, the proposed agenda is better to be discussed with representatives of the Roszdravnadzor. “Participation of the regulatory authorities is very important to us. Results of the new practices will depend on cooperation between the regulators. The system of registration should be synchronized with pharmacovigilance, in terms of practices, the implication of the laws, and a single interpretation of clinical trials,” said Mr. Dmitriev.

Participants of the meeting agreed with the ARPM proposal to include experts from the Rosdravnadzor, as well as members of scientific and clinical trial communities.

According to the recent Governments order on “Changes to the Regulations of the Federal Service of Pharmacoviligance”, the Roszdravnadzor has functions to check the safety of biomedical cellular products and their market circulation.

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