Emerging Markets: A Snapshot of Impending Track and Trace Requirements for Australia, Egypt, Russia, Saudi Arabia, and Taiwan
By the year 2020, track and trace regulations will cover more than 80 percent of the global drug supply. Today you may
Here, we take a look at five emerging markets—Australia, Egypt, Russia, Saudi Arabia, and Taiwan—and give you a snapshot of
Highlight: A new regulation for bar code identification for all pharma products was recently passed.Details: Previously existing regulations have focused exclusively on blood products. A law has been in place for barcoding and serialization for blood components and fresh blood products, which phases in between 2016-2019.In September 2016, new regulations were published, requiring
Highlight: There is a proposed serialization and track and trace reporting regulation currently circulating as a set of presentations by the ministry.
Details: The proposed serialization and track and trace reporting requirement includes:
Egypt has signaled an interest to follow Turkey’s model for a traceability and compliance reporting system, and it is expected to phase in between 2016-2019.
Heads Up: Formal draft regulations may be published by end of 2016, but at this time it is hard to pinpoint when the law will get signed.
Highlight: A draft regulation, based on a previously published concept paper, is expected to become law.
Details: A concept paper published in January 2015 lays the foundation for a forthcoming law that is expected to be a comprehensive serialization and traceability regulation for products in the Russian market (i.e., drugs manufactured within or imported into Russia).
Similar to Turkey’s regulation, it involves applying unique serialized ID to drug products and capturing and reporting to a central repository key events associated with those products as they move through the supply chain.
Many details still are unknown but should be spelled out in a forthcoming technical guideline. These include:
- The exact serialization identifier
- The bar coding scheme
- Data that is to go into the bar code
- The exact method of connecting to and transmitting the information to the central repository
It includes a voluntary pilot phase and successive phases for implementation applying to an increasingly broad set of drug products in the marketplace.
Heads Up: It is fully anticipated that the set dates for the phased implementation will change. It’s also probable that the number of phases leading up to deployment will be adjusted. What will not change is the general approach to implementation that’s been spelled out: A phasing in of the regulation across an increasing set of drug products.
To date, not enough details have been provided for companies to take concrete steps towards readiness. And between now and 2020, expect things to be in a constant state of churn.
Highlight: A formal law currently enforces bar code regulation. The regulatory scope will expand to include serialization by early next year. Government reporting requirements are on the horizon, as well.
Details: Regulators are working on the next phase of their requirements for the existing law covering barcoding (Phase 1 completed), enhanced serialization (phase 2 beginning March 2017), and compliance reporting (Phase 3 deadline still undetermined).
The requirements are following GS1 standards for both the barcode and data.
Product scope for the regulations includes all pharmaceutical products, including human and veterinary.
Emerging requirements: The original law has always stated that there will be forthcoming requirements for reporting information about the products to some central repository.
Heads Up: The country is looking at Turkey as a potential model for a traceability and compliance reporting system with enhanced serialization requirements including navigation.
The timing of compliance reporting requirements is still undetermined. It could be as early as the phase 2 serialization deadline of March 2017, but this is still under discussion.
Highlight: The TFDA started circulating in August 2016 a proposed regulation to modify their four-phase draft regulation to two phases.
Details: A draft regulation expected to become law by the end of 2016 includes four phases (
Verbal reports from the industry indicate that the
The proposed idea is to phase in barcoding and serialization at the saleable unit of all drug products on a selected drug list by 2019. By 2020, the same barcoding and serialization will be required for all pharma products.
Heads Up: It’s fully expected that this proposed regulation will become law by end of 2016. Though, the requirements may continue to evolve.
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This snapshot of what’s bubbling up in five emerging markets just touches the surface of the more than 40 countries that have implemented regulations or are proposing the implementation of track and trace regulations by 2020.
While it’s difficult to know today exactly how regulations will take shape from country to country in the years to come, here is what we can anticipate with certainty:
1. Business as usual
Because of the scale and scope of the global regulations being developed, meeting track and trace requirements will become business as usual for companies across the global supply chain. Track and trace will no longer be a side project but rather, it will be baked into the DNA of every company that is producing, distributing, or dispensing drugs.
Far from a convergence on a single set of compliance information and events, diversity in regulations and the rules that govern them will be the norm for the foreseeable future.
3. Continual change
We’ll see a constant evolution over the next decade, as new government regulations are proposed and turned into laws, and as existing countries either phase in successive enhancements to existing regulations or change existing regulations.