Draft:Trvst
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| TRVST | |
|---|---|
| Developers | UNICEF (under the Verification and Traceability Initiative) |
| Release | July 2022 |
| Operating system | Web-based platform with mobile scanning application |
| Available in | English |
| Type | Pharmaceutical traceability and verification |
| License | Non-commercial, multi-stakeholder |
| Website | www |
The Traceability and Verification System (TRVST) is a digital platform developed by UNICEF that enables governments, regulatory authorities, and supply-chain partners to verify the authenticity of medicines, vaccines, and other health products and to trace them through the Pharmaceutical distribution.[1] Launched in July 2022, the platform was created in response to the global circulation of counterfeit and substandard medical products, which the World Health Organization estimates may account for around one in ten medical products in certain regions.[1][2]
TRVST is developed under the Verification and Traceability Initiative (VTI), a multi-stakeholder partnership that includes the Bill & Melinda Gates Foundation, the European Commission, Gavi, the Global Fund, UNICEF, the USAID, the World Bank, and national regulatory authorities in Nigeria and Rwanda.[1][3]
Background
[edit]The World Health Organization estimates that approximately one in ten medical products circulating in certain low- and middle-income regions may be falsified or of substandard quality, a problem driven by an industry estimated to be worth approximately US$30 billion annually in such markets.[1] Counterfeit and substandard medicines have been linked to treatment failure, direct patient harm such as poisoning, and an estimated 169,000 child deaths each year from substandard or falsified antimicrobials used to treat childhood pneumonia.[4]
Prior to the development of TRVST, track and trace systems for pharmaceutical products had been implemented in high-income markets — notably under the Drug Supply Chain Security Act in the United States and the Falsified Medicines Directive in the European Union — but many low- and middle-income countries lacked equivalent national infrastructure.[5]
History
[edit]TRVST was launched in July 2022, with the first GS1-standard serialized vaccine scans taking place in Nigeria and Rwanda.[2] At launch, Dr. Emile Bienvenu, Director General of the Rwanda Food and Drug Administration, described the platform as a tool to support the strategic objectives of Rwanda's national strategy for pharmaceutical traceability.[2]
A second version of the platform, incorporating track-and-trace capabilities based on the Electronic Product Code Information Services EPCIS standard, was planned for integration with national systems in Nigeria and Rwanda, with additional countries including Malawi and Nepal expressing interest in adoption.[3]
In 2025, Ghana's Food and Drugs Authority, in partnership with UNICEF Ghana, hosted a stakeholder workshop to begin the pilot rollout of TRVST as Ghana's national traceability and verification system.[6]
In December 2025, the supply-chain technology company TraceLink announced support for TRVST, providing a route for pharmaceutical manufacturers already serializing products for the United States and European Union markets to register product data in the TRVST repository.[7]
Governance
[edit]TRVST is operated by UNICEF and governed through the Verification and Traceability Initiative, a multi-stakeholder partnership whose members include:[1][3]
- Bill & Melinda Gates Foundation
- European Commission
- Gavi, the Vaccine Alliance
- Global Fund to Fight AIDS, Tuberculosis and Malaria
- UNICEF
- United States Agency for International Development (USAID)
- World Bank
- National medicines regulatory authorities in Nigeria and Rwanda
The World Health Organization is also identified by some implementation partners as a contributor to the initiative.[5] Program management for the initiative has been provided by the consultancy Vital Wave.[3]
Architecture and operation
[edit]TRVST consists of a central global repository, a verification workflow, and an alerting mechanism.[1][5]
Global repository
[edit]The TRVST repository is a standards-based database storing product and event information uploaded by pharmaceutical manufacturers, including Global Trade Item Numbers (GTINs), serial numbers, batch numbers, and production and expiry dates.[1][8]
Verification
[edit]A mobile application allows users in the field — including healthcare workers, regulatory authorities, and customs agents — to scan a GS1 barcode on a medical product and receive a real-time verification result against records held in the global repository.[1][2]
Alerting
[edit]When a verification fails, or when a scan pattern is flagged as suspect, the system automatically generates alerts that are routed to both the product's manufacturer and the relevant national regulatory authority for investigation and response.[5]
Standards and interoperability
[edit]TRVST is built on GS1 global data standards, including barcoding specifications and the Electronic Product Code Information Services (EPCIS) standard for supply-chain event data.[1][3] The use of GS1 standards is intended to allow manufacturers already serializing medicines for the United States Drug Supply Chain Security Act or the European Union Falsified Medicines Directive to reuse the same identifiers and data structures when registering products in the TRVST repository.[5][8]
Implementation
[edit]The first operational use of TRVST took place in Nigeria and Rwanda in July 2022.[2] Subsequent countries that have expressed interest in or begun adoption of the platform include Malawi, Nepal, and Ghana.[3][6]
UNICEF has identified two requirements for the success of TRVST: adoption of the platform by national governments and the embedding of TRVST in regulatory, customs, and healthcare workflows; and serialization of medical products by manufacturers serving low- and middle-income markets, together with the registration of those products in the global repository.[1]
See also
[edit]- Track and trace
- Counterfeit medications
- Drug Supply Chain Security Act
- Falsified Medicines Directive
- GS1
- Pharmaceutical distribution
- Serialization (pharmaceutical)
References
[edit]- ^ a b c d e f g h i j "Traceability and Verification System (TRVST)". UNICEF Supply Division. Retrieved 16 June 2026.
- ^ a b c d e "First serialized vaccine scan in Africa marks milestone in tackling falsified medical products". UNICEF Supply Division. August 2022. Retrieved 16 June 2026.
- ^ a b c d e f "Verification and Traceability Initiative". TechNet-21. Retrieved 16 June 2026.
- ^ "TRVST System Enhances Global Health Product Traceability". Trace Wire. 29 August 2024. Retrieved 16 June 2026.
- ^ a b c d e "TRVST: Traceability and Verification System". Hello Pharma. 15 June 2026. Retrieved 16 June 2026.
- ^ a b "FDA and UNICEF Ghana Launch Stakeholder Workshop to Drive Rollout of National Traceability and Verification System". Food and Drugs Authority, Ghana. Retrieved 16 June 2026.
- ^ "TraceLink Supports UNICEF's Traceability and Verification System (TRVST) to Advance Safe, Authentic Medicine Access Globally". PR Newswire. 11 December 2025. Retrieved 16 June 2026.
- ^ a b "One Year of TRVST Connectivity: What Operational Readiness Really Means". SoftGroup. 17 December 2025. Retrieved 16 June 2026.
External links
[edit]- Traceability and Verification System (TRVST) — UNICEF Supply Division