The Philippines FDA mandates that all sellable pharmaceutical units must bear a Global Product Identification Number (GPIN), which serves as a globally recognized identifier accepted by the World Health Organization and World Customs Organization. This standardized approach enables seamless tracking across international borders and provides a unified framework for product identification. All products must display both the GPIN and establishment number on their packaging, creating a dual-layer identification system that enhances traceability and authenticity verification.

By regulatory mandate, all pharmaceutical products must feature either a barcode or QR code corresponding to their GPIN, along with essential product information including batch numbers, lot numbers, and expiration dates. This digital coding system transforms traditional labeling into an intelligent tracking mechanism that enables real-time product verification. The labeling requirements apply uniformly to both imported and locally manufactured products, ensuring consistent traceability standards across the entire pharmaceutical market.

The regulation establishes differentiated processes for imported versus locally manufactured products while maintaining uniform traceability standards. For imported products that already possess a GPIN, local distributors need only obtain an establishment number from the FDA, streamlining the import process without compromising traceability. Local manufacturers must join recognized global standards organizations to obtain both establishment identification numbers and GPINs, ensuring their products meet international traceability benchmarks from production inception.

The Philippines FDA employs a sophisticated 14-digit Document Tracking Number (DTN) system for all regulatory submissions, complaints, and communications. This comprehensive tracking mechanism ensures complete transparency in regulatory processes and enables stakeholders to monitor the status and progress of their applications in real-time. The DTN system requires both printed and electronic submissions, creating a robust audit trail that supports regulatory compliance and facilitates efficient communication between pharmaceutical entities and regulatory authorities.