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Manila Bulletin devider Philippines devider National devider FDA extends validity of licenses, certificates to boost drug accessibility

FDA extends validity of licenses, certificates to boost drug accessibility

Published Feb 13, 2024 06:34 am

Food and Drug Administration (FDA) Director General Samuel Zacate on Tuesday, Feb. 13 said the agency has extended the license to operate (LTO) and certificate of product registration (CPR) renewal period from three years to five years.

FDA.png
(FDA)

"Now it will be increased to five years initial to 10 years renewal. It will help the stakeholders for the drug to further their business interest and to strengthen the drug accessibility in the country," he explained during the Presidential Communication Office press briefing.

This extension applies not only to drugs but also to food and devices, Zacate clarified.

However, he noted that cosmetics are exempted due to the myriad variations among stakeholders.

Meanwhile, responding to inquiries about the anticipated impact on drug prices in the country, Zacate indicated that the effects would likely manifest within six months.

"As of now, the two policies, the administrative order for the unified licensing, and the revision of fee for increasing the CPR validity will be transmitted to the Department of Health (DOH) because it is not an administrative order," Zacate said.

He further outlined the process, saying after transmission to the DOH and subsequent signing by the DOH Secretary, the FDA will implement rules and regulations accordingly.

Zacate emphasized the benefits of the extended validity, highlighting the assurance it provides stakeholders regarding product availability for a longer duration, subject only to post-marketing surveillance.

The FDA said that this move is poised to streamline processes and bolster drug accessibility across the nation.

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