Registration is now open for the webinar "Orphan Drug Status: Regulatory Approaches and Practices of EAEU Countries"

The event is organized by
The CIS Orphan Consortium
jointly with the Association of International Pharmaceutical Manufacturers.

May 13, 2026
12:00 (Moscow time)
Online (in Russian)

The registration, development, and launch 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 topic is particularly relevant in the countries of the EAEU. where recognition of a drug as an orphan drug remains closely linked to national criteria for rarity, national lists, and subsequent decisions on drug provision.

During the webinar, experts will discuss:

• International approaches to assigning orphan status
• Experience of law enforcement in the EAEU countries
• Differences between registration and compensation mechanisms
• Possible areas for harmonization of regulation in the Union countries

Presentations will be given by:

• Maria Ovsyanitskaya - member of the Committee on Regulation of Circulation of Medicines of the Association of International Pharmaceutical Manufacturers (AIPM) "Status Orphan Drug: Analysis of International Legislation and Legislation of the EAEU Countries"
• Daria Zvereva - Member of the AMFP 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 - Chairperson of the AMFP Committee for the Regulation of Circulation of Medicines "Prospects for the Development of EAEU Legislation and AMFP Proposals"

We invite all specialists interested in creating a predictable and effective regulatory environment for orphan drugs in the EAEU countries to participate.