Guidance for applications and transactions at FDA in light of the community quarantine 

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FDA

The Food and Drug Administration (FDA) has released Circular No. 2020-006 entitled, “Guidance for Applications and Transactions at the Food and Drug Administration in light of the Community Quarantine Declaration”.

FDA shall adopt alternative work arrangements and function with limited workforce to ensure continuity of government service during this time while protecting FDA employees.

Initial applications for License to Operate (LTO), Certificate of Product Registration (CPR)/ Certificate of Product Notification (CPN) will still be processed online thru the FDA ePortal System, however High Priority will be given to establishments involved in diagnosis, treatment, mitigation, prevention of COVID- 19 and manufacture or distribution of personal protective equipment (PPE) and essential medicines.

“There will be corresponding adjustments on the date of validity for LTO/CPR/GMP Renewal application and Inspection which are fair to manufacturers and establishments” Director General Eric Domingo said.

All manufacturers, traders, and distributors with products containing 70% alcohol and below used as antiseptic, antibacterial, and sanitizer must secure an LTO and CPN from the FDA Center for Cosmetics Regulation and Research (CCRR).

“We shall be temporarily suspending all initial CPR applications starting March 17- May 17 2020, except for antivirals, antibiotics, and vaccines as well as drugs used for emergency management of patients with COVID-19, so as not to paralyze our current health needs” Domingo added.

“During these challenging times, FDA will continue to perform its mandate of ensuring the public health safety without compromising service delivery. We value our personnel, employees, and stakeholders and we shall continue to assist the government in its response to this pandemic” Domingo concluded./Stacy Ang

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