The most significant regulatory updates within the Russian life sciences and pharmaceutical sector during the second quarter of 2023 include the following:

1. The Russian Government approved the Strategy for the Development of the Pharmaceutical Industry of the Russian Federation for the Period up to 2030 (the "Pharma 2030 Strategy").
2. The Eurasian Economic Union (EAEU) amended the Rules for Registration and Evaluation of Medicines, revising the compliance assessment procedures for manufacturing sites regarding EAEU Good Manufacturing Practice (GMP) requirements.
3. Regulatory authorities updated the Vital and Essential Medicines List (EDL), clarifying specific dosage forms for a range of pharmaceutical products.
4. New regulatory provisions took effect governing the compounding and dispensing of pharmaceutical products by licensed pharmacy organizations.
5. The state introduced additional eligibility criteria for sole-source suppliers within the public procurement framework for pharmaceuticals.
6. The legislature established administrative and criminal penalties for violating dispensing rules concerning over-the-counter distribution of medicines subject to mandatory subject-quantitative accounting.
7. The Ministry of Health proposed permitting the inclusion of off-label drugs—used in accordance with indications or characteristics not specified in their instructions for use—into pediatric medical care standards and clinical guidelines.
8. A new initiative seeks to revise specific calculation formulas utilized to determine maximum manufacturer selling prices for the Vital and Essential Medicines List (EDL).

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