DOH tells Cavite LGU: COVID-19 clinical trials need prior approval

Metro Manila (CNN Philippines, September 2) — The Department of Health on Wednesday reminded local officials of Cavite that securing regulatory approval is necessary before the province can conduct a COVID-19 vaccine clinical trial.

Cavite Governor Jonvic Remulla announced last week that 10,000 Caviteños will participate in the trials for the coronavirus vaccines developed by American and British pharmaceutical companies this month.

Health spokesperson Maria Rosario Vergeire said they have notified the head of the research team that they need to obtain the approval of the Food and Drug Administration and ethics review board before starting the Phase 3 of the trial. After these steps, they need to inform the DOH that the trial is all set to begin.

She highlighted the importance of proper regulatory process to ensure the safety of the participants.

“Walang pwedeng mag-umpisa ng any clinical trial kung walang approval ng FDA at ethics review. If you do that, you are violating specific law. So, you will be sanctioned and you will be asked to stop” Vergeire added.

[Translation: A clinical trial cannot begin without an ethics review and an approval of the FDA.]