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Philippines: South Korean MFDS as Reference Drug Regulatory Authority

Updated: 7 days ago

On 29 April 2024, the Philippines FDA added Korea’s Ministry of Food and Drug Safety (MFDS) as its new Reference Drug Regulatory Authority Agency, which is expected to facilitate pharmaceutical exports to the Philippines.


The approval period for pharmaceutical registration will be significantly reduced to one (1) month via the Facilitated Review Pathway (FRP). Previously, the approval period to enter the Philippines market would take four (4) to six (6) months. Korea hopes the FRP system will increase the export rate of local pharmaceutical products.


MFDS has maintained an excellent performance by gaining few achievements in the last few years. In October 2023, MFDS was listed in the WHO-Listed Authorities (WLA) and obtained the highest grade in the WHO Global Standard (GBT) Evaluation of the Pharmaceutical and Vaccine Regulatory System in 2022.

 

 

Contact us at info@arqon.com for more information.

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