Malaysia Expands Voluntary eLabeling for Generic OTC Medicines

Malaysia’s Drug Control Authority (DCA) officially announced the voluntary adoption of eLabeling for all generic OTC drugs categorized as non-scheduled poisons. This initiative is part of the nation’s strategy to accelerate digital transparency and sustainability objectives in pharmaceutical labeling practices.

Key highlights include:

  • Regulatory Guidance: The DCA released updated Regulatory guidance and FAQs for manufacturers and distributors, detailing digital access methods, permitted QR code use, and required content structure for e-labels.
  • Digital Transformation: The guidance highlights the integration of electronic labeling with supply chain tracking, promoting public accessibility and environmental sustainability.
  • Implementation Process: Manufacturers may participate in the voluntary program from October 2025 to December 2026. The DCA will monitor adoption rates, gather stakeholder feedback, and plan for mandatory implementation based on outcomes.
     
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