𝐔𝐧𝐩𝐨𝐩𝐮𝐥𝐚𝐫 𝐨𝐩𝐢𝐧𝐢𝐨𝐧: 𝐓𝐫𝐚𝐜𝐤 & 𝐓𝐫𝐚𝐜𝐞 𝐢𝐬 𝐧𝐨𝐭 𝐨𝐧𝐞 𝐝𝐞𝐬𝐢𝐠𝐧𝐞𝐝 𝐬𝐲𝐬𝐭𝐞𝐦
There is one global technical language (GS1 standards, 2D DataMatrix, EPCIS)… but very different regulatory objectives behind it.
Let's go through some examples :
𝐓𝐡𝐞 𝐑𝐞𝐚𝐥 𝐃𝐢𝐟𝐟𝐞𝐫𝐞𝐧𝐜𝐞: 𝐓𝐫𝐚𝐜𝐞𝐚𝐛𝐢𝐥𝐢𝐭𝐲 𝐯𝐬 𝐕𝐞𝐫𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧
Here is where many professionals get it wrong.
Some countries build Traceability Systems
→ The regulator wants to know where every pack is, when it entered a warehouse, when it left, and where it moved next.
This creates strong market control and visibility.
𝐄𝐱𝐚𝐦𝐩𝐥𝐞𝐬: #Tatmeen, previous #RSD model, upcoming Egyptian hub model, CIS countries (with crypto code embedded inside the GS1 DataMatrix).
Other regions build Verification Systems
→ The regulator’s priority is authenticity check, not full movement reporting.
They want to verify the product is genuine when dispensed, without tracking every warehouse transaction.
𝐄𝐱𝐚𝐦𝐩𝐥𝐞𝐬:
EMVO | European Medicines Verification Organisation
UNICEF TRVST
#DSCSA
#TRVST even extends verification to patient level in certain humanitarian markets.
𝐂𝐞𝐧𝐭𝐫𝐚𝐥𝐢𝐳𝐞𝐝 𝐯𝐬 𝐃𝐢𝐬𝐭𝐫𝐢𝐛𝐮𝐭𝐞𝐝 𝐇𝐮𝐛𝐬
Highly centralized models:
Tatmeen, EMVO, Egypt’s upcoming hub, RSD , Ethiopia, CIS (with crypto code requirements).
→ Every stakeholder reports transactions to a national hub.
Distributed model:
DSCSA (US)
→ Blockchain-based interoperable exchange between trading partners. Regulator oversight is conditional.
𝐎𝐩𝐞𝐫𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐄𝐱𝐚𝐦𝐩𝐥𝐞𝐬
1️⃣ Free Medical Samples – Same product, different logic
In #Tatmeen (UAE)
Free samples, must be serialized and reported like commercial packs.
In #RSD- SFDA - هيئة الغذاء والدواء (Saudi Arabia)
Commercial samples may be exempt from standard flow, but if selected for port testing, they must be deactivated in the system. Operational control is selective and risk-based.
In Egyptian Drug Authority (Egypt)
Certain free medical or research samples fall outside the commercial traceability reporting scope.
2️⃣ Unregistered Drugs – Full reporting or limited scope?
=In UAE and KSA:
Serialization and reporting apply to both registered and unregistered drugs. All packs are tracked across the supply chain.
=In Egypt:
Unregistered products may fall outside mandatory reporting in certain cases.
If we dive deeper into implementation strategies, we clearly see that national regulatory authorities adopt very different approaches when rolling out track and trace systems.
And that’s why true Track & Trace implementation is never copy-paste.
It’s configuration thinking aligned with regulatory intent.