Preparing for global track and trace regulations is a strategic requirement.
In the fight to protect patient safety and ensure product integrity, countries around the world have accelerated their adoption of track and trace regulations.
With regulations covering more than 75% of the global medicine supply by 2018, preparing to meet these regulations is a fact of life for all companies
across the Life Sciences supply chain.
Major regulations facing the industry and complicating your supply planning and network IT architecture include:
- United States: Drug Supply Chain Security Act (DSCSA) regulations for tracing drug product transactions, serializing
products at the smallest saleable unit level and verifying product identity and transaction histories phased in on January 1, 2015.
- European Union: Falsified Medicines Directive requirements for the serialization of drug products, reporting of product
master data and serialization data, and verification of drug products at point of dispensation are expected to start in the second quarter
of 2018. Details.
- China: Track and trace regulations for the serialization of pharmaceuticals using unique China identifiers and reporting
to the China CFDA of drug product events began in 2013 with medicines on the 2009 Essential Drugs List and completes on December 31, 2015 with
all pharmaceutical requiring serialization and reporting. Details.
- Brazil: The Resolucao da Diretoria Colegiada of December 10, 2013 (RDC 54) established regulatory requirements for complete
serialization, tracking from manufacture to dispensation and reporting of product and transaction data to ANVISA. Phase 1 implementing
RDC 54 requirements begin on Dec. 10, 2015 with full implementation of all ANVISA registered medicines required one year later in 2016.
Ensure readiness for both government and trade track and trace requirements.
TraceLink's comprehensive global track and trace platform minimizes your risk, cost and time in meeting today's diverse and evolving global track and
trace compliance requirements - with a single connection.
- Create serial numbers and monitoring of allocations for all product types, packaging configurations and global serialization requirements
- Manage serial number requests from internal packaging sites and external CMO/CPO partners
- Create, manage and archive transaction history, information, and statements for US Drug Supply Chain Security Act (DSCSA)
- Enable end-to-end supply chain tracking of drug products and their movements for Brazil and elsewhere
- Establish a global, standardized approach to government reporting from China, to Brazil, Argentina, Turkey and elsewhere
- Enable verification of product identity and transaction histories from all points in the supply chain for the US, EU and
- Support global patient access to product identity verification through mobile devices