In order to address the ongoing pandemic, the President was empowered to implement an uninterrupted immunization program against vaccine preventable diseases. In relation to this, Phase IV trials for COVID-19 medication and vaccines were waived in order to expedite the procurement process, subject to certain provisos. In lieu thereof, the President authorized the Director General of the Food and Drug Administration (“FDA”) to issue Emergency Use Authorization (“EUA”) on a COVID-19 drug or vaccine.
In the Lexology article entitled: "Philippine FDA Advisories on Emergency Use Authorization of Drugs and Vaccines Against COVID-19,” Villaraza & Angangco's Ma. Sophia Editha C. Cruz-Abrenica and Edward King L. Chua review the advisories issued by the FDA regarding EUA of drugs and vaccines against COVID-19, compare an EUA vis-à-vis a Certificate of Product Registration (CPR), and discuss the guidelines on requirements, approval, cancellation/ suspension of granted EUA, as well as the obligations of a holder of an EUA to provide further information on vaccines already approved and pending for issuance of EUA in the country.
Access the article here: https://www.lexology.com/library/detail.aspx?g=caa71db3-1576-49f4-aea2-213f3239e870