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FDA guarantees quality of generic drugs despite faster registration process
FDA guarantees quality of generic drugs despite faster registration process
In response to a recent move to shorten the registration process for generic and essential drugs from 120 to 45 days, the Food and Drug Administration (FDA) assured the public on Friday, Feb. 16, that the quality of medicines will remain “uncompromised."
READ: https://mb.com.ph/2024/2/15/fda-introduces-facilitated-review-pathway-for-generic-drugs
"Lagi namang sinisigurado ng FDA na ang mga gamot ay ligtas, mabisa at dekalidad (The FDA always ensures that medicines are safe, effective, and of quality),” said FDA’s Communication Section, Policy and Planning Services Officer II Jordan Paguirigan in an interview with TeleRadyo Serbisyo.
He said the facilitated review pathway (FRP) ensures that medicines entering the Philippines are already registered in other countries, thus upholding stringent safety and efficacy standards.
The FDA's circular includes a list of counterparts of the FDA in the Philippines, indicating their origin countries, Paguirigan pointed out.
"Once na nakita ng FDA na okay registered dito [sa ibang bansa], ichecheck at ie-evaluate ng mabuti 'yung application ng gamot and mabilis na ang approval nito (Once the FDA sees that it is okay registered here [in another country], they will thoroughly check and evaluate the drug application, and its approval will be expedited)," he explained.
Meanwhile, addressing concerns about prescription practices, Paguirigan cited the Generic Act of 1988, which mandates doctors to prescribe medications using their “generic names.”
While brand names may also be included, the generic name must be “prioritized,” he said.
Generic vs branded medicine
Moreover, contrary to misconceptions, Paguirigan affirmed that generic medicines are “equivalent in quality and effectiveness” to their branded counterparts, citing laboratory tests that verify consistency in drug content.
"Base sa mga testing natin sa laboratory, chinecheck po talaga natin na pantay ang amount ng gamot doon sa generic at branded (Based on our laboratory testing, we really ensure that the amount of medication in both generic and branded drugs is consistent)," he stressed.
Meanwhile, the FDA aims to enhance the availability of all generic and essential drugs on the market, aiming for affordability and accessibility for all Filipinos.
This encompasses medications for various conditions, including maintenance drugs and cancer treatments.
Paguirigan highlighted that the shortening of this registration process will commence once there are applications for generic medications, including both local and international ones.