v. 28 – Q4 2023

Market Executive Summary The Ministry of Health (MoH) of Malaysia announced at the National Regulatory Conference on October 5 its intention to establish a full track and trace centralized model of drug traceability system by 2023. MoH agreed with the project and Ministry of Finance now needs to approve.

Pilot project is on the way since July 2022. Pilot project Report and implementation guide is expected to be shared in the July 2023 timeframe.

They want to model their system based on Turkey since they believe that Turkey is the most successful implementation thus far.

The benefits and usage of GS1 are fully supported and understood.

The goal behind implementing a track and trace system is beyond just counterfeits:

  • Cost optimization by reducing waste due to product obsolescence and better forecasting
  • Strengthen regulatory activities
  • Enhance ecosystem of pharma sector, bolster growth on exports to countries that have already implemented Track and Trace
  • Improve patient safety by minimizing medication errors, product authentication, and track products to the end points

Industry agrees with T&T implementation, but concerns on timeline, implementation cost, and authority engagement (or lack of it, missing guidelines).

Key Dates
  • 2023: Enforcement data expected projected timelines see in Add’l comments section)
  • Q1 2022: government development system available for pilot testing
  • VMS = Vaccines traceability system for COVID-19 vaccines
  • 2005 to 2023 products secured by hologram label; following end of hologram contract aim is to move to traceability system

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