The Regulatory Response to Economic Sanctions: New Mechanisms Vital for Future Development of the Pharmaceutical Industry
Today, providing citizens with affordable, high-quality medicines in the context of the restrictive economic measures imposed on the Russian Federation is the key priority for the regulatory system for medicines. The Russian regulatory system, using the experience accumulated during the pandemic of making effective decisions to extremely tight deadlines, has demonstrated its resilience and readiness to respond quickly to global challenges, by showing how constructive and flexible it is and drawing on the principles of openness and cooperation. The creation of effective new legislation and the introduction of viable mechanisms of state support to ensure the future development of the national pharmaceutical industry are a fundamental ingredient in the industry’s progress. To date, how effective are the conclusions of the interdepartmental commission in identifying medicines which are deficient, or at risk of becoming so? What results have been achieved in the area of state registration of medicines as well as that of the introduction of changes to documents in the registration dossier on an expedited basis? What solutions are needed for drug pricing issues in the context of the economic sanctions that have been imposed on the Russian Federation? What issues in the area of authorization require solutions in the Russian Federation in the context of the sanctions (moratoria in the pharmaceutical industry and other mechanisms)?
Dmitriy Galkin, Director of Department of Pharmaceutical and Medical Industry Development, Ministry of Industry and Trade of the Russian Federation
Sergey Glagolev, Deputy Minister of Health of the Russian Federation
Valentina Kosenko, General Director, Scientific Center for Expertise of Medicinal Products of the Ministry of the Ministry of Health of the Russian Federation
Timofey Nizhegorodtsev, Deputy Head, Federal Antimonopoly Service of the Russian Federation (online)
Aleksandr Petrov, Head of the Expert Council for Regulating the Circulation of Medicines and Medical Devices, Committee of the State Duma of the Federal Assembly of the Russian Federation on Health Protection
Evgeniya Shapiro, Director General, PSK Pharma