Pharmaceutical giant Pfizer intends to file the emergency use authorization (EUA) of its anti-COVID-19 pill Paxlovid in the Philippines, the Food and Drug Administration (FDA) said Thursday.
By HANA BORDEY, GMA News
Published May 5, 2021 7:43pm The government must work on ensuring the traceability of COVID-19 vaccines to avoid the entry or distribution of counterfeit jabs, a global standards expert said Wednesday. In a roundtable discussion Wednesday, GS1 Philippines chairman Jesus Varela warned that once the COVID-19 vaccines are commercially available, counterfeits and substandard jabs will flood the market. Varela mentioned a previous Food and Drug Administration memorandum circular which requires product information such as product identification number, barcode, distributor and manufacturer information. He said that the memorandum was suspended by the FDA. “Sa amin napakaimportante na ito ay maituloy dahil ito naga-identify ng produkto para madaling ma-trace [For us, it is very important to continue this memorandum because we can identify the products and we can easily trace this]. One of the solutions in checking counterfeits is the traceability of
December 13, 2020 THE Food and Drug Administration (FDA) has launched the pilot implementation of fully automated e-services systems that require only 14 working days to issue the License to Operate (LTO) and 20 working days to issue the Certificate of Product Registration (CPR).
Dr. Oscar Gutierrez Jr., officer-in-charge-director of the Policy and Planning Service of FDA, explained that the current migration from a semi-automated system (https://eportal.fda.gov.ph) to a fully automated system (https://eservices.fda.gov.ph/) is meant to promote ease of doing business and contactless transactions.
Gutierrez in a recent webinar said with the new e-LTO portal, applicants no longer need to e-mail FDA to ask for the log-in name and password for access, but can simply apply directly from the new website.