Pharmaceutical Medical Circulation: at Special Focus
Last week XVIII Russian National Conference “State Regulation in the Field of Drugs and Medicinal Devices” PharmMedCirculation 2016 was held in Moscow.
Representatives of Russian federal and regional legislative and executive authorities, specialized international regulatory organs and international organizations, research and public organizations, professional associations, retail and wholesale organizations and medical manufacturers took part in the conference.
Opening the conference, Igor Kagramanyan, First Deputy Minister of Healthcare, Russia, marked important trends in development of control in healthcare. In particular, he paid attention to the new type of public control – random quality control of drugs, suggesting obligatory provision of information on batches and lots that are released for civil circulation. Besides, he remarked the planned stage-wise introduction of automated drug flow monitoring system from manufacturer to end user using individual package labeling to increase effects of quality control and struggling counterfeit.
The issues discussed at the conference included control and circulation of narcotic drugs, psychotropic substances and their precursors, cultivation of narcotic-containing plants in the territory of the Russian Federation. Issues of control and surveillance in the sphere of drug circulation, regulation in the sphere of circulation of biomedical cell products, as well as marketing authorization of medical devices in the light of the new legislation of Eurasia Economic Union.
It was remarked, that GMP standards are a key element of providing the quality of manufacture of drugs.
Particular attention was paid to public control of clinical trials in the Russian Federation and EEU. In particular, new regulatory requirements to organization and conduct of clinical trials in the European Union, on general requirements to conduct and control were discussed.
Besides, the conference raised questions of national policy in the field of pharmaceutical and healthcare industry.