House urges FDA to hasten procedures for CPR, EUA permits of local pharmaceuticals

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Metro Manila (CNN Philippines, April 18) -- House Speaker Lord Allan Velasco on Sunday appealed to the Food and Drug Administration to expedite the procedures concerning the application of local drug makers for certificates of product registration and emergency use authorization permits amid the pandemic.

Velasco said local pharmaceuticals can boost the country’s response against COVID-19 but government agencies should strike a balance between the "thorough study of drugs" and making compliance easier for the drug firms.

“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,” he added.

Meanwhile, Deputy Speaker Bernadette Herrera-Dy said based on computations from the current FDA checklist, it will take a company at least eight months to complete the requirements needed for the issuance of a CPR. But business insiders said that the process for CPRs usually takes longer than that, she added.

Velasco and Herrera-Dy earlier filed a resolution calling for an inquiry on the policies set by the DOH and the FDA in approving COVID-19 drug products.

“Even from a trade and industry perspective, it is alarming that a number of local pharma producers have actually been forced to close, simply because they could no longer afford to wait for the FDA to grant them their permits,” Herrera-Dy said.

She also said the government should provide support to the local drug makers.

“This can be done through direct grants from Bayanihan 3, soft loans or credit subsidies, or tax considerations. Now is the perfect time to look into these options, and to maximize our resources,” she said.