Webinar: Orphan Drug Status: Regulatory Approaches and Practices of EAEU Countries
Webinar "Orphan Drug Status: Regulatory Approaches and Practices of EAEU Countries"
CIS Orphan Consortium in conjunction with the Association of International Pharmaceutical Manufacturers
May 13, 2026
12:00 (Moscow time)
Online (in Russian)
Registration, development, and marketing of orphan drugs remain one of the most challenging tasks of modern pharmaceutical policy.
Differences in approaches to determining orphan status, requirements for its confirmation, and enforcement practices in different countries directly impact registration timelines, treatment availability, and the predictability of the regulatory environment for developers.
This issue is particularly relevant in the EAEU countries, where orphan drug designation remains closely linked to national criteria for rarity, national lists, and subsequent decisions on drug availability.
During the webinar, experts will discuss:
-
International approaches to assigning orphan status
-
Law enforcement experience in EAEU countries
-
Differences between registration and compensation mechanisms
-
Possible areas for regulatory harmonization in the Union countries
Presentations will be given by:
-
Maria Ovsyanitskaya - Member of the Association of International Pharmaceutical Manufacturers (AIPM) Committee for the Regulation of Circulation of Medicines, "Orphan Drug Status: Analysis of International Legislation and the Legislation of the EAEU Countries"
-
Daria Zvereva - Member of the AIPM Committee for the Regulation of Circulation of Medicines, Head of the Orphan Drug Working Group, "Experience in Enforcement of Orphan Drug Status in the EAEU Countries"
-
Anna Lakhtanova - Chair of the AIPM Committee for the Regulation of Circulation of Medicines, "Prospects for the Development of EAEU Legislation and AIPM Proposals"
We invite all specialists interested in creating a predictable and effective regulatory environment for orphan drugs in the EAEU countries to participate.
