FDA Compels Drug Manufacturers To Adopt Unique Global ID To Ensure Drug Safety

The Food and Drug Administration (FDA) has adopted the Unique Global Product Identification Number (UGP-IN) system which ensures traceability and safety of globally-traded health and medical products.

The new regulation imposes the use of the UGP-IN, a system similar to the internationally-accepted GS1, on all establishments engaged in the manufacturing and trading of health products.

The policy was issued last April 29 through FDA Circular 2014-011 signed by FDA Director Kenneth Y. Hartigan-Go.

The new regulation will take effect one year after its issuance or in June 2015.

Philippine representatives of the GS1 global organization said FDA’s adoption of the new policy indicates government’s strong support for the distribution of high-quality drugs and health products in the country.

“Through this ID system, we will be able to ensure the right medicine is administered on patients. Expired drugs’ being found in the market will become a thing of the past,” said Edward David who is with the GS1 local office.

Because there will be reliable bar code system, fake medical products may easily be identified, David said.

The FDA circular noted that the Philippines is aligning its policy on health products with current international efforts on product safety.

The Asia Pacific Economic Cooperation (APEC) Ministers Meeting issued in October 2013 a statement supporting global data standards that assure food and drug safety.

Bar code

Under the circular, a unique identification code is assigned to each product.

A barcode, a Quick Response code (a trademark for a barcode type that has edge over usual barcodes in terms of quick readability and storage), or any electronic identification mark is given to each product.

The circular mandates that all establishments should obtain a Global Trade Item Number or GTIN from an independent agency. With the GTIN assigned to each product, any product found hazardous to health may be traced to its manufacturer anywhere in the world.

GS1 Philippines

GS1is an international non-profit association present in more than 100 countries.

The GS1 Philippine has the GS1 system that improves the management of supply chain– the series of steps in the process of moving goods and services from raw materials to consumers.

GS1 provides training and support for the production of bar codes (numbering and bar coding); eCom (EDI or Electronic Data Interchange); and Global Data Synchronisation Network (GDSN).

It also supports the use of a technology, radio frequency identification (RFID), a system of identifying objects that have tags through wireless transmission of data.

GTIN

Each GTIN is permanently assigned as the identification number of each product associated with a company. The number has no expiration.

Likewise, each manufacturing batch or lot should have its own GTIN.

The system ensures traceability which protects customers as the product can be identified to a specific source or manufacturer of whatever country under this globally-recognized system.

The system is recognized by the World Customs Organization and the World Health Organization.

The GTIN should be reflected in in labels of products.

“Appropriate identification numbers must be displayed on the product exterior in a manner that allows unaided visual verification by amajority of consumers,” said the circular. “Failure to provided a verifiable GTIN by itself is sufficient ground for denial of (a product’s FDA) application.”

The UGP-IN, the circular noted, is issued by international organizations and implemented in more than 100 countries.

“A global product identification system strengthens enforcement against counterfeit products, facilitates execution of risk management plans including recalls and bans, and enables global identification of products manufactured in the Philippines by local companies,” said the FDA.

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For any questions, or interview requests, please contact Ms. Analiza C. Mendoza, 0921-338-3816, 0916-266-6604.