The Food and Drug Administration (FDA) received a report of the non-availability of Nirmatrelvir + Ritonavir, a drug product, granted with an Emergency Use Authorization (EUA) and Conditional Marketing Authorization (CMA), indicated for the treatment of COVID-19 in adults and adolescents (12 years of age and older weighing at least 40 kg) who do not require supplemental oxygen and who are at risk for progression to severe COVID-19. The EUA Holder has confirmed that they have no importation yet as they are still finalizing the required pharmacovigilance and supply chain system stipulated in the issued EU and CMA.
In reference to the Administrative Order No. 2021-0053 entitled “Guidelines on the procurement, Distribution and Rational Drug Use of COVID-19 under Emergency Use Authorization (EUA)” which states that COVID-19 Drugs granted with EUA shall no longer be applied for CSP after a specified time period determined by the Philippine FDA, the FDA shall approve CSP applications for the time being to provide access of Nirmatrelvir + Ritonavir in the country.
The application for CSP of Nirmatrelvir + Ritonavir shall be accepted until such time that the EUA holder will be ready to provide supply. This is subject to re-evaluation of current availability of the supply and status of registration of this COVID-19 drug.
The FDA continues to work with the government and health care industry to ensure access to this lifesaving commodity during this public health emergency.
For inquiries or clarification, you may email the FDA Clinical Research Section at [email protected].