How to Implement a National Drug Traceability System: A Guide for Regulatory Entities

Counterfeiting medicines represents one of the biggest challenges for global healthcare systems. According to WHO estimates, up to 30% of medicines in emerging countries can be falsified, generating millions of dollars in losses and direct risks to public health.

Faced with this scenario, the implementation of a Serialization and Traceability Law becomes a strategic State decision.

But where to start?

Below, we share the main steps and key decisions that a regulatory entity must consider when designing and implementing a national pharmaceutical traceability system.

1. Define the system model

The first step is to determine the scope of the model:

• Full Track & Trace (all links report in real time)
• Verification system (activation in the laboratory, deactivation during dispensing)

In addition, depending on the chosen model, the actors in the supply chain reached must be defined.

International experience shows that comprehensive models (Full Track & Trace) offer greater control, transparency and auditing capacity.

2. Establish identification standards

It is essential to adopt international standards that allow for interoperability and scalability.

The most widely used standard globally is GS1, which defines:

• GTIN (Global Trade Item Number)
• Unique serial number per unit

The uniqueness of each drug comes from the combination GTIN + serial number, allowing individual traceability at the secondary container level.

The standard contemplates SSCC coding for logistic aggregation. In addition, relevant data such as batch code or expiration date can be printed in the unique code of the secondary package.

3. Determine identification technology

Technologies must be flexible but compatible with global standards:

• Linear barcode
• DataMatrix 2D code

There is also the possibility of printing both on conditioning lines and using thermal transfer labels for low-volume products. The decision must consider the technological reality of laboratories and distributors in each market.

4. Define the database model

One of the most sensitive points in any traceability regulation is information management:

• Centralized database managed by the health authority
• Distributed model with interoperability

In any scenario, regulation must comply with international data integrity and security regulations (such as 21 CFR Part 11 or Eudralex Annex 11) and provide clear access and privacy policies.

In this regard, data governance is key to ensuring transparency and trust in the system.

5. Determine achieved products

The most successful implementations start with:

• Gradual lists of critical medications
• Progressive incorporation in phases
• Subsequent expansion to medical devices

Staged implementation facilitates industry adoption and reduces operational risk.

6. Establish realistic implementation timelines

Regional experience shows that deadlines should include:

• Technological adaptation of laboratories
• Integration of distributors and logistics operators
• Pharmacy and hospital training
• Pilot testing before official launch

A staggered schedule allows for greater stability and less regulatory friction.

7. Technical support and validation

A national traceability system must be:

• Validable according to GAMP5 criteria
• Compatible with GS1 standards
• Certificate in quality and information security (ISO 9001 and ISO/IEC 27001)
• Capable of integrating with international systems

Choosing technology partners with proven experience in real implementations significantly reduces project risks.

Proven experience in real implementations

Countries that have implemented successful systems share a common factor: strategic planning, international standards and specialized technical support.

The Argentine experience, for example, demonstrated that a model with a centralized database, GS1 standards and gradual adoption can achieve effective integration between the public and private sectors.

Traceability as a public health policy

Beyond regulatory compliance, serialization and traceability allow:

• Combating counterfeiting
• Reduce diversions and fraud
• Protect the patient
• Generate transparency in the chain
• Improve the oversight capacity of the health authority

Traceability is not just a technical obligation. It is a structural tool for strengthening the healthcare system.

Are you considering implementing a Traceability Law in your country?

Having specialized technical advice from the early stages of regulatory design can make the difference between a theoretical system and an operating system, which is interoperable and sustainable over time.

Learn more about implementation models and regional experiences in our blog.