FDA explains drug approval process

The Food and Drug Administration (FDA) on Friday said that medical drugs, including those for the coronavirus disease 2019 (COVID-19), must first undergo a process before being approved for commercial use.

"Pag sinabi po kasi natin na ang isang gamot ay rehistrado o aprobado ng FDA, ibig sabihin yung gamot po na iyon ay talagang nasuri at na-testing para sa partikular na sakit na sinabi niya na gagamutin niya," FDA spokesperson Eric Domingo said in a live briefing.

According to Domingo, individuals who wish to have their products approved must first demonstrate how their drugs were processed.

"Unang-una kailangan ipakita natin na yung factory natin ay tama ang pagkakagawa, kailangan pakita natin na ang proseso ng paggawa natin ng gamot ay tama at sumusunod sa international standard," he said.

"Kailangan ipakita natin lahat ng ingredients nung gamot na yon para siguradong walang nakakasama or harmful," he added.

Afterward, the drugs must undergo a thorough clinical trial wherein the drug will be tested on animals before being tested on people.

"[P]agkatapos susubukan siya sa taong malulusog para malaman yung kanyang safety, pagkatapos susubukan naman siya sa taong may sakit para makita kung meron siyang efficacy or effectiveness," Domingo said.

For those who wish to apply for an approval of a new drug, Domingo said that it must undergo all steps from manufacturing to a clinical trial.

Meanwhile, existing drugs created for a different disease that may want the approval for another disease must undergo a clinical trial.

"[K]asi kailangan masiguro natin yung safety ng isang produkto. Halimbawa, ang isang produkto, ibibigay mo sa isang daan na may sakit. Kung gumaling nga yung 50 pero yung 20 namatay naman, eh di may problem tayo," he said. —LDF, GMA News