Duque proposed EUA for COVID-19 vaccines in the Philippines.
Health Secretary Francisco Duque III had proposed the emergency use of COVID-9 vaccines once arrived in the Philippines in order to speed up the processing of their regulatory approval.
On Tuesday night, Duque asked President Duterte in a meeting on the government’s pandemic response to allow the Food And Drug Administration (FDA) in the Philippines to issue the emergency use authorization (EUA) for vaccines, technologies, and medicines in order to fight the spread of coronavirus disease (COVID-19).
Emergency use authorizations were applied to justify the use of certain medical products during a public health emergency in order to diagnose, treat, or prevent life-threatening condition or disease.
“Para mabilis po ito, it will cut the processing time from six months to about 21 days, Mr. President. So it will cut the red tape and, again, that is for your consideration,” he added.
READ ALSO: Galvez Backs Duque’s Proposal To Issue EUA For COVID-19 Vaccines In PH
Duque also said that the emergency use authorization would facilitate the approval of medical technologies and products during the pandemic through the process of “reliance” and “recognition”.
In addition, Duque said that “reliance” referred to the Food And Drug Administration’s trust in the evaluation made by other regulatory authorities abroad in deciding on the application of a medical product in the Philippines.
On the other hand, Duque said that “recognition” was the Food And Drug Administration’s routine acceptance of the regulatory decision of other regulatory authorities and trusted institutions.
READ ALSO: US FDA To Make EUA Data Public For COVID-19 Vaccines
Moreover, Duque explained that emergency use authorization was used when there’s a medical health emergency, a life-threatening or serious disease, proof that the said product may be effective to diagnose, prevent, or treat a disease, positive risk/benefit balance, and when there’s no approved or adequate alternative available.
“The FDA will conduct post-marketing surveillance activities and may revise or revoke the EUA if needed to protect public health,” Duque said.
Meanwhile, the Food And Drug Administration in the United States would make public reviews of all information and data about the emergency use authorization granted to COVID-19 vaccines.
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