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FDA urged: Expedite giving EUA, CPR to local pharmas
“While we understand the need for thorough study of drugs and medicines, we need to balance it out by making compliance easier for local pharmaceutical firms by cutting out unnecessary red tape and redundant requirements,” Velasco said, urging the FDA to hasten the processing of applications for Certificate of Product Registration and emergency use authorization permits.
Manjunath Kiran/AFP

FDA urged: Expedite giving EUA, CPR to local pharmas

Delon Porcalla (The Philippine Star) - April 20, 2021 - 12:00am

MANILA, Philippines — Local pharmaceutical companies that manufacture anti-COVID-19 drugs should be given priority by the Food and Drug Administration (FDA), Speaker Lord Allan Velasco said yesterday.

“While we understand the need for thorough study of drugs and medicines, we need to balance it out by making compliance easier for local pharmaceutical firms by cutting out unnecessary red tape and redundant requirements,” Velasco said, urging the FDA to hasten the processing of applications for Certificate of Product Registration (CPR) and emergency use authorization (EUA) permits.

Based on computations from the FDA checklist, it will take a company a minimum of eight months to complete the requirements needed for the issuance of a CPR. Business insiders say, however, that CPRs usually take far longer than that, if they are issued at all.

“There are countless reports of local drug manufacturers whose products have been stuck in regulatory limbo for years. These bureaucratic impediments are something that we need to eliminate, especially during a public health crisis,” Velasco emphasized. – Louella Desiderio

FDA PHARMACEUTICAL
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