New requirements for state registration of medicinal products in Uzbekistan have been approved.
Now, detailed information about GMOs and substances derived from animal raw materials in medications must be provided.
In the Ministry of Justice, an instruction establishing new requirements for documents submitted for the state registration of medicinal products has been registered. This was reported by the Telegram channel "Huquqiy axborot" in a post.
According to this document, documents for the registration of medicinal products are submitted based on the standards of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. The new procedure is aimed at ensuring the implementation of the regulation approved by Resolution No. 738 of the Cabinet of Ministers dated November 24, 2025.
In accordance with the instruction, if substances derived from animal raw materials are used in the production of a medicinal product, the documents must clearly indicate whether or not they contain prions.
Additionally, it is permitted to include supplementary information in the instructions for the medical use of the medicinal product that complies with international requirements and does not have an advertising nature.
According to the new requirements, information about whether the medicinal product contains genetically modified organisms (GMOs) or is derived from them must also be submitted on a mandatory basis.
In this case, information must be provided regarding the type and source of genetic modification, the genetic construct and expression system used, biological and environmental safety measures, the stages in the production process where substances derived from GMOs are used, and documents related to genetic safety.
