Philippine FDA will cut registration time, says health sec

By Gareth Macdonald

- Last updated on GMT

Related tags Fda

The world’s newest pharma industry regulatory body was set up in Phillipines yesterday with the foundation of a new agency modelled on the US FDA.

The Philippine Food and Drug Administration (FDA), which was brought into being by new legislation enacted by President Gloria Macapagal-Arroyo, replaces the Bureau of Food and Drugs (BFAD) as the country’s drug and food safety monitor.

A press release issued by the office of president Macapagal-Arroyo explained that the new agency will have greater regulatory powers than the BFAD and will be able to retain income it generates to help fund its activities.

Philippine health secretary Francisco Duque III told the country’s Business Mirror​ website that the agency has powers the BFAD had lacked, including the ability to order the ban, recall or withdrawal of drug products.

Duque went on to say that the additional funds available to the FDA, compared with the BFAD, will allow it to expand analysis capacity and cut average product registration times from the current average of nine months to less than three.

The law the founds the FDA also calls for the establishment of three new drug testing laboratories in Luzon, Visayas and Mindano to bolster operations at existing central facilities in the capital Manila that were formerly operated by the BFAD.

Export potential

A June report by Episcom Business Intelligence revealed that the Philippine pharmaceutical market was worth around $1.4bn (€991m) last year, which is comparable with Pakistan and Thailand.

Although relatively small in global terms, any change in how the Philippine drug market is governed is likely to pique the interest of the pharmaceutical industry, particularly given the Big Pharma trend towards expansion in emerging economies.

Such companies may also be attracted by the Philippines’ potential as an export destination given that the country currently imports nearly two thirds of its drugs according to data released by the US Department of Commerce.

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