regulatory Compliance Guidelines

Uzbekistan Pharma Regulatory Compliance Updates 2025

3 min read

Published on

December 11, 2025

Uzbekistan’s xTrace 2.0 introduces major updates to authentication, serial number rules, and reporting requirements for pharmaceutical manufacturers. Manufacturers can use this guide to understand what’s changing and how to prepare their systems and processes.

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Uzbekistan’s national traceability system, ASL Belgisi (xTrace), has released a new set of compliance and API updates that significantly change how pharma manufacturers authenticate, generate, and report serialization data. Over the past week, we have analyzed these updates in detail, including the shift from the legacy SUZ/IZKM API to the new Open API, revised field requirements, and new guidelines for serial number generation.

These updates represent a major modernization of Uzbekistan’s pharmaceutical traceability landscape and will directly impact MAHs, Manufacturers, and Traceability/Integration/Regulatory Compliance service providers operating across the region.

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‍Why Were These Changes Introduced?

The updates released under xTrace 2.0 are part of a broader effort to modernize Uzbekistan’s pharmaceutical traceability infrastructure. As the volume of serialized products increases and cross-border integration becomes more important, the revised data structures help in strengthening system reliability, reducing errors, and bringing Uzbekistan closer to international traceability standards.

1. Enhanced Security

Legacy integrations relied on static identifiers such as omsId and clientToken.
The new Open API introduces:

Short-lived API keys (valid for 30 days)
Bearer token authentication

This shift significantly increases system security and reduces the risk of unauthorized access.

2. Alignment With International Standards

xTrace 2.0 introduces fields and structures already common in global serialization ecosystems, such as:

businessPlaceId
manufacturerCountry (ISO formats)
Updated releaseType mapping

This aligns Uzbekistan with systems used in the EU, Russia (Chestny ZNAK), Kazakhstan, and the UAE.

3. System Modernization

xTrace removes outdated structures and deprecated parameters, improving backend stability and performance. The API is cleaner, leaner, and built to scale.

4. Improved Data Quality

Key fields are now mandatory, including:

productionDate
expirationDate
seriesNumber
businessPlaceId
releaseType

This ensures better accuracy across the entire traceability chain.

5. Reduced Integration Errors

The new API:

Removes unused fields: templateId, stickerId, factoryName, productCode, productionLineId
Requires Base64-encoded documents for reporting
Provides clearer and more actionable validation messages

This lowers the error rate during data exchange and reduces back-and-forth with the regulatory authorities.

6. Centralized Business Location Management

businessPlaceId is now system-generated inside ASL Belgisi, ensuring standardized and verified identifiers for manufacturing and warehouse locations.

7. Strengthened National Compliance

By modernizing authentication, reporting, and serialization logic, xTrace 2.0 enhances anti-counterfeit controls and improves visibility across the supply chain.

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All About New Serial Number Rule (AI 21)

One of the most significant updates released last week concerns the formation of packaging serial numbers (AI 21).

Here is the exact rule change:

As-Is: Serial numbers were fully random
To-Be: All serial numbers must now begin with the digit “7”‍
- This prefix is automatically added by the system
- Code templates and total length remain unchanged (13 characters).

Purpose of the change

The change ensures serial numbers follow a uniform structure across the region. Manufacturers will need to update their serial number generation logic in all integrated serialization and packaging systems.

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Legacy API vs. Open API: Complete Breakdown of Changes

Below is a consolidated, technically detailed view of the major technical changes that were introduced:

Feature	Legacy API	New Open API	Comments
Authentication	omsId (query) + clientToken (header)	API Key + Bearer accessToken (valid 30 days)	Improves session security and reduces unauthorized access risks
Ping Method	Supported	Removed	Heartbeat checks must use other operational endpoints
Emission Order (Crypto Code Request)	releaseMethodType: Production / Import / Leftovers Required many fields (templateId, stickerId, factoryId, productCode, etc.)	releaseMethodType: Primary Marking / Marking Outside Production releaseType moved to usage report Many parameters deprecated factoryId → businessPlaceId	Simplifies structure and aligns with new reporting logic
Emission Order Status	Basic filtering (date, status)	Advanced multi-parameter search and filtering	Better traceability and monitoring
Fetching Emission Codes	lastBlockId, blockId	lastPackId, packId	Updated naming for improved clarity
Usage Report	usageType optional productionDate & expirationDate optional	Mandatory fields: • releaseType • manufacturerCountry • businessPlaceId • productionDate • expirationDate • seriesNumber (for some groups)	Improves reporting accuracy and data quality
Aggregation Report	JSON sent directly Required: participantId, productionLineId, aggregationType, sntins	JSON must be Base64 encoded (documentBody) sntins → codes, reportId → documentId New field: shouldBeUnbundled	Standardizes report formatting and enhances validation
Aggregation Report Status	reportId, reportStatus, errorReason	documentId, status New metadata: createDate, originalDocId, type, productGroup	Provides more detailed tracking and debugging info
Report Content Retrieval	Not available	New endpoint to fetch full document body	Improves auditability and troubleshooting
Listing Reports	Basic listing	Advanced search & filtering	Faster navigation for large datasets
Listing Document Errors	No dedicated method	Dedicated endpoint for all processing errors	Greatly improves error visibility and debugging

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Readiness Checklist for Uzbekistan’s New Traceability Rules

Uzbekistan’s transition to xTrace 2.0 impacts multiple layers of serialization, reporting, and technical integration. Below is an expanded readiness checklist to help MAHs, manufacturers, and CMO partners prepare effectively.

Category	Action Area	Key Requirements
Operational Alignment	Review Production & Aggregation Workflows	• Align workflows with updated `releaseType` definitions • Ensure aggregation rules match the new xTrace hierarchy • Validate parent–child relationships before submission
	Master Data Validation	• Verify product master, GTINs, dosage forms • Confirm manufacturing & warehouse locations match assigned `businessPlaceId` • Ensure all CMOs receive updated integration guidelines
	Inventory Already Serialized	• Previously generated serials (from IZKM systems) without the “7” prefix remain valid • Segregate old and new serial ranges • Ensure warehouse teams understand prefix change and handling
	Update SOPs & Documentation	• Revise internal SOPs and quality documentation • Re-certify processes if required by internal QA teams
	Training & Communication	• Train operators, QA, IT/integration teams • Include CMOs and repackers in communication • Prevent mix-ups between legacy and new serial ranges
Technical Readiness	Update Authentication & Connectivity	• Switch to API Key + Bearer Token authentication • Ensure connectivity to all Open API endpoints • Review token renewal, firewall rules, and basic security settings
	Adopt New AI 21 Serial Number Rule	• All new serials must begin with “7” • Retain 13-character total length • Ensure systems do not double-prefix if the platform auto-applies the “7”
	Support New Mandatory Fields	• Update systems to store and send: `productionDate`, `expirationDate`, `seriesNumber`, `manufacturerCountry`, `businessPlaceId`, `releaseType`
	Update Reporting Format	• Submit reports as Base64-encoded documents (`documentBody`) • Validate system capability to generate and store encoded data
	Remove Deprecated Parameters	• Clean out old fields from legacy templates • Prevent validation errors caused by obsolete parameters
Integration & Testing	Evaluate Existing Integrations	• Review L3/L4/L5 integration points • Replace legacy endpoints with Open API equivalents
	Conduct Basic Regression Tests	• Test AI 21 “7” prefix serial creation • Submit emission orders using updated structure • Validate Base64 aggregation reporting • Confirm new error handling responses
	Perform End-to-End Submission Tests	• Verify request formatting • Validate encoding accuracy • Ensure successful system responses • Confirm compliance with updated validation rules
	Coordinate With CMOs & Partners	• Share updated xTrace requirements • Sync `businessPlaceId` values • Validate serialization and aggregation flows between systems

Early adaptation will help avoid compliance gaps as the transition becomes fully enforced.

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Final Thoughts

Although these updates may appear extensive, xTrace 2.0 represents a major improvement in security, data quality, compatibility, and regulatory alignment. With stronger authentication, standardized structures, and clearer reporting rules, Uzbekistan is moving toward a more modern, globally interoperable pharmaceutical traceability ecosystem.

At AltiusHub, we remain in active communication with ASL Belgisi, and related regulatory authorities to ensure our interpretation stays accurate and up to date. Our platform is fully prepared for the new requirements, and our team is continuously reviewing updates to guide manufacturers, MAHs, and CMOs through a smooth transition.

We will continue to publish verified insights, implementation guidance, and best practices, supporting the industry as it adapts to Uzbekistan’s evolving compliance landscape.

To know more about AltiusHub, and how we can help you in this journey: Book A Demo

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Frequently Asked Questions (FAQs)

1. Will older serial numbers (without the “7” prefix) remain valid?

Yes. ASL Belgisi support team confirmed that serial numbers generated before the update remain active and valid, including those already printed on cartons or pallets.

2. Should we modify historical data or reprint already serialized products?

No. Previously printed serial numbers do not require rework.

3. Will Uzbekistan customs reject shipments containing old serial number formats?

No. ASL Belgisi support team has clarified that customs will continue to accept legacy serial formats generated before the update.

4. Do manufacturers need to generate the “7” prefix manually?

No. The system automatically applies the prefix. You only need to ensure your serialization logic supports the updated rule and does not apply the prefix twice.

5. What is businessPlaceId and why is it important?

It is a system-generated location identifier assigned by ASL Belgisi for each valid facility. It ensures location data is standardized and trusted.

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