Platform Technology Regulation as a Tool for Accelerating Drug Development: Analysis and Prospects for Russia

Objective. The objective of this study is to demonstrate the potential of the platform approach in the regulation of biotechnological drug development, supported by specific examples and case studies from FDA practice. The study examines the Platform Technology Designation Program (PTDD) of the U.S. Food and Drug Administration (FDA), launched in 2024. This program serves as a regulatory mechanism for granting platform technology status and has practical value for accelerating drug development and review through the justified reuse of data. Obtaining platform technology status entitles the developer to partially reuse CMC (Chemistry, Manufacturing, and Controls) data from an already approved drug when submitting applications for subsequent products based on the same “backbone.” The article discusses the mechanisms for granting such status, examples from FDA practice, as well as Russian companies possessing similar technologies and the potential for their development. Based on the analysis, a conclusion is drawn regarding the feasibility of implementing analogous regulatory mechanisms in Russia.

1. Анализ регулирования платформенных технологий в биомедицине, НТИ Хелснет, 31 мая 2026. URL: https://healthnet.academpark.com/analytics/analiz-regulirovaniya-platformennyh-tehnologij-v-biomediczine/

2. FEDERAL FOOD, DRUG, AND COSMETIC ACT. As Amended Through P.L. 119–175, Enacted February 3, 2026. URL: https://www.govinfo.gov/content/pkg/COMPS-973/pdf/COMPS-973.pdf

3. ELEVIDYS, FDA, 11/14/2025. URL: https://www.fda.gov/vaccines-blood-biologics/tissue-tissue-products/elevidys

4. FDA Grants Krystal Biotech Platform Technology Designation, Marking Strategic Shift in Gene Therapy Oversight. URl: https://fairsonline.org/fda-grants-krystal-biotech-platform-technology-designation-marking-strategic-shift-gene-therapy