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Manila Bulletin devider Philippines devider National devider FDA introduces 'facilitated review pathway' for generic drugs

FDA introduces 'facilitated review pathway' for generic drugs

Published Feb 15, 2024 08:35 am

The Food and Drug Administration (FDA) introduced on Thursday, Feb. 15, the Facilitated Review Pathway (FPR) for generic drugs, marking a substantial initiative directed towards simplifying regulatory procedures and enhancing the availability of crucial medication.

FDA.png
(FDA)

In a statement, the introduction of the FDA Circular streamlines the evaluation and approval timeline for generic drugs from a previous duration of 120 working days to an expedited period of just 45 days.

This accelerated process is expected to significantly reduce administrative obstacles, ensuring the faster availability of vital medications to the public.

Moreover, the FDA underscored its commitment to maintaining the safety, efficacy, and quality of every generic and essential drug accessible to the public.

This assurance comes amidst growing concerns over the reliability of generic medications, reaffirming the agency's dedication to safeguarding public health.

Furthermore, the FDA said that spearheaded by the Center for Drug Regulation and Research under the guidance of Director Jesusa Joyce Cirunay, this initiative marks a pivotal step towards enhancing healthcare services across the Philippines.

It also highlighted that the announcement comes in response to President Marcos Jr.'s directive to enhance government services.

Additionally, it said that the statement reflected a commitment to efficiency and aligns with the administration's economic renewal agenda, emphasizing the role of drug manufacturing in driving national prosperity.

The FDA emphasized that this latest development signals an effort by the FDA to uphold healthcare standards while fostering economic development, paving the way for a new Philippines where essential medications are readily accessible to all citizens.

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