Uzbekistan Sets ICH-Aligned Drug Registration Rules

Tashkent, Uzbekistan (UzDaily.com) — Uzbekistan Aligns Pharmaceutical Registration With Global Standards, Mandates GMO and Prion Disclosures

Uzbekistan has formalized a new regulatory framework for pharmaceutical registration that aligns documentation requirements with international standards — introducing mandatory disclosures on genetically modified organisms and prion risks that bring the country's drug approval process closer to globally accepted norms.

The Instruction on Documentation Requirements for State Registration of Medicinal Products was registered by the Ministry of Justice on June 4, 2026, under registration number 3848.

The ICH alignment:

At its core, the regulation requires that all registration dossiers submitted under Uzbekistan's existing pharmaceutical registration framework conform to standards set by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) — the body whose guidelines govern drug approval processes across the European Union, United States, Japan, and a growing number of emerging markets. Adoption of ICH standards is widely regarded as a prerequisite for pharmaceutical export competitiveness and foreign investment in domestic drug manufacturing.

GMO transparency requirements:

The instruction introduces a specific and detailed disclosure regime for medicines involving genetically modified organisms — either as ingredients or in the manufacturing process. Producers must document the type and source of genetic modification, the genetic constructs used, the expression system employed, applicable biological and environmental safety measures, and the specific production stages where GMO involvement occurs. The requirement applies equally to finished product labeling and registration documentation.

Prion risk disclosure:

For medicines derived from or manufactured using animal-origin substances, registration documents must explicitly state whether prion-related materials are present or absent — a safeguard provision reflecting international post-BSE regulatory sensitivities around biological contamination risk in pharmaceutical supply chains.

Labeling flexibility with limits:

The regulation also permits manufacturers to include supplementary information in patient leaflets and prescribing information where such additions align with international standards — provided the content carries no promotional character. The carve-out for non-advertising supplementary information gives manufacturers room to include clinically relevant context without opening the door to label-based marketing.

The regulation positions Uzbekistan within a wider trend of Central Asian states modernizing pharmaceutical governance frameworks as they seek to attract foreign drug manufacturers, expand domestic production capacity, and reduce dependency on imported medicines — a strategic priority that has intensified across the region since supply chain disruptions exposed vulnerabilities in the early 2020s.