Philippines FDA Compliance

• Obtain company authorization and product registration through the FDA eServices framework before placing product on the market. (eservices.fda.gov.ph)

• Assign a GTIN or equivalent unique global product identification number to each product and include it in the FDA registration record.

• Ensure the product exterior carries the identification number and or its scannable graphic in line with FDA requirements.

• Confirm that approved product records are correctly reflected in the FDA Verification Portal after approval. (FDA Verification)

• Maintain accurate product records, packaging data, and approved product information to support verification, market surveillance, and recall readiness. (Food and Drug Administration)

The Philippines FDA uses digital platforms for product registration and product verification:

• FDA eServices Portal for licensing and product registration workflows. (eservices.fda.gov.ph)

• FDA Verification Portal for public verification of licensed establishments and registered health products, including drug products. (Food and Drug Administration)

These portals support regulatory authorization and verification. As of the currently published FDA materials reviewed here, there is no published requirement for a national pharma event reporting hub that captures commission, aggregation, shipping, receiving, or decommission events at serial number level. This is an inference from the scope of the published FDA requirements and portals.

There is no published nationwide FDA requirement, in the sources reviewed, mandating case or pallet aggregation for pharmaceutical products as part of a national traceability program. No published rule was identified requiring SSCC based parent child hierarchy reporting to a central national repository. This conclusion is based on the currently available FDA serialization and identification guidance reviewed here.

• Using a GTIN that does not match the registered product record.

• Treating the GTIN as a batch or lot number. The FDA explicitly states that product identification is not equivalent to a manufacturing batch or lot number.

• Failing to place the product identification number or equivalent scannable graphic on the product exterior.

• Assuming that the Philippines currently requires full serial level reporting similar to markets with mature national traceability hubs. The currently published FDA framework reviewed here is product identification focused, not a published end to end national serial event reporting model.

• Not validating whether the registered product, package insert, and patient information leaflet appear correctly in the FDA Verification Portal. (Food and Drug Administration)