2025 Global Serialization Regulations in the Pharmaceutical Industry

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Countries where pharma serialization is already implemented

Pharmaceutical serialization is already fully enforced across a wide range of countries and regions. This includes most of the European Union under the EU FMD framework, as well as national systems in Argentina, Australia, Bahrain, Brazil, Canada, China, Ethiopia, Greece, Belgium, India, Iran, Japan, Kazakhstan, Kyrgyzstan, Lebanon, Oman, Russia, Saudi Arabia, South Africa, South Korea, Tajikistan, Turkey, the UAE, the USA, and Uzbekistan.

These countries operate either centralized national repositories or GS1-based traceability systems and require full compliance for pharmaceutical products. Serialization and reporting are mandatory and subject to audits.

SoftGroup supports pharma companies operating in these regulated markets with validated solutions, automated reporting to national systems, and secure integration across the supply chain.

These countries have fully enforced serialization regulations for pharmaceutical industry:

• Argentina  (2015)
• Australia* – implemented but not mandatory
• Bahrain
• Brazil (April 2022)
• Canada (December 2021)
• China (2022)
• Ethiopia (February 2025)
• EU (February 2019)
• Greece (February 2025)
• Belgium (February 2025)
• India (January 2023)
• Iran (January 2015)
• Japan (January 2023)

• Kazakhstan (July 2024)
• Kyrgyzstan 2023/2024
• Lebanon (January 2023)
• Oman (March 2019)
• Russia (July 2020)
• Saudi Arabia (March 2017)
• South Africa (June 2022)
• South Korea (January 2015)
• Tajikistan (January 2025)
• Turkey (January 2010)
• UAE (January 2022)
• USA (May 2025)
• Uzbekistan (February 2022)

Countries where the deadlines for the implementation of pharma serialization have been set

Several countries have formally set deadlines and are actively onboarding pharma companies. Italy are finalizing their integration with the EU FMD via national systems, with 2025 as a key milestone. Others launches their systems and continue onboarding with phased requirements. Other have all published timelines for full serialization rollout in the next 12–24 months. These markets are in transition: systems are live or going live, but regulatory monitoring is still evolving.

SoftGroup helps pharma businesses meet tight deadlines and avoid late compliance penalties through structured rollout support and localized configurations.

These countries have formally announced serialization requirements with clear compliance deadlines. While not yet fully enforced in all cases, their national systems are active or in final rollout phases. Pharma companies operating here must act quickly to ensure readiness and avoid non-compliance once enforcement begins.

• Armenia (January 2026)
• Italy (February 2027)
• Indonesia (December 2025)
• Malaysia (2027)

• Pakistan
• Rwanda (August 2026)
• Sri Lanka (December 2025)
• Ukraine (January 2028)

Want a summary of all deadlines and statuses?

Download the 2025 Global Serialization Checklist (PDF)

Countries where pharma serialization is currently under discussion

Markets like *Algeria, Morocco, Armenia, and **India* are in various stages of preparing their serialization frameworks. Algeria published GS1-based draft guidelines in 2024, while Morocco and Armenia have initiated pre-regulatory consultations. India, though advanced in serialization for exports, is still shaping national-level domestic traceability enforcement. These countries are not yet enforcing serialization, but the direction is clear.

Companies selling into these regions can benefit from early readiness and partner alignment — SoftGroup closely follows every step of their regulatory development to keep you ahead of the curve.

These countries are in active consultation, guideline drafting, or early-stage roadmap preparation. While serialization is not yet enforced, the direction is clear. Companies distributing in these markets can gain competitive advantage by preparing early.

Countries where pharma serialization implementation is on hold

Not all national serialization programs have gone according to plan. Some were launched but paused mid-rollout, while others have faced legal, infrastructure, or political delays. While compliance is not currently enforced, companies operating in these markets should remain prepared.

SoftGroup helps clients maintain readiness in case of sudden reactivation, ensuring configurations can be re-enabled without rework.

• Belarus
• Ecuador
• Libya

• Paragua
• Peru
• Philipines

Countries where pharma serialization is not required

Some markets currently have no official serialization laws or regulatory announcements. However, this may change rapidly, especially as trade partners increase expectations around traceability and supply chain transparency.

With SoftGroup, you can activate market-specific serialization even where no law demands it, ensuring your supply chain stays resilient and future-ready.