Alexander Martynenko (AIPM) delivered a presentation at the congress on the topic of maintaining the availability of a wide range of medicines. He emphasized the importance of a balanced approach to the use of preferential measures in the public procurement process. The conference was attended by representatives of the patient community.
MEETING OF THE WORKING GROUP OF THE EURASIAN ECONOMIC COMMISSION ON MEDICINES REGULATION
14 – 15 November | 11, 12, 18 December
The members of the AIPM Regulatory Committee attended the EEC working groups focused on the regulation of the EAEU pharmaceutical market. Elena Popova, representing the industry, presented the industry's perspective on the changes to the EEC Council Decision No. 78 regarding GMP inspections, renewal of GMP certificates, parallel inspections, and registration procedures. She also discussed the process of updating the registration dossier when there are changes in the OHLP and LV, and the timeframe for applicants to do so. Anna Lakhtanova, the Chair of the AIPM Regulatory Committee, suggested ways to streamline the process of making changes to the registration dossier. The working groups also discussed topics such as electronic trade in medicines and the import of medicines, testing of electronic systems, availability of data in the Unified Register of Medicines of the EAEU, posting summaries of the risk management plan in the Register, registration at the initiative of authorized bodies, and the extension of the EEC Council Decision No. 96 (interim measures) until December 31, 2027. Almira Galeeva, representing the AIPM, has put forward industry recommendations for aligning the new version of the EAEU Good Clinical Practice (GCP) regulations with the amendments to the Decision of the Eurasian Economic Commission Council No. 79.
ALL-RUSSIAN CONGRESS OF PATIENTS
27–29 November
The round table “Intellectual Property Protection today – patients' access to innovative therapies tomorrow” discussed the regulation and protection of intellectual property in the context of the availability of innovative therapies. The participants concluded that it is necessary to balance the interests of patients, the state and business to ensure the long-term availability of such medicines and proposed specific measures to improve regulatory regulation. Larisa Matveeva (AIPM) was the co-moderator of the session and participated in the plenary discussion of the Congress. Maria Demidova, a member of the AIPM Pharmacovigilance working group, made a presentation on the pharmacovigilance system in the Russian Federation at the round table “Citizen is the main value of the welfare state of Russia”.
THE AIPM AND THE FEDERAL STATE BUDGETARY INSTITUTION NCESMP OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION HELD A MEETING
8 November | 10 December
The AIPM and the Federal State Budgetary Institution NCESMP of the Ministry of Health of the Russian Federation held a series of meetings to review medicinal products and harmonize expert work. At the meeting attended by V.V. Kosenko, the Director General of FSBI NCESMP, the Board of the Regulatory Committee of the AIPM presented an analysis of current issues in expertise and law enforcement. Elena Popova (AIPM) presented the results of a study conducted by the Association for monoclonal antibody testing, and Olesya Funtyasheva, a member of the AIPM Regulatory Committee, shared the industry's perspective on the assessment and quality control of biotechnological medicines. It was agreed to continue discussing and developing comprehensive proposals, taking into account pharmacopeial requirements and quality standards.