Duterte signs EO allowing FDA to issue EUA for COVID-19 vaccines

President Rodrigo Duterte has signed Executive Order 121, granting the Food and Drug Administration (FDA) the authority to issue emergency use authorization (EUA) for COVID-19 drugs and vaccines.

This executive order aims to expedite the approval process for these critical medical supplies, reducing the usual six-month timeframe to just 21 days for local use.

An EUA will be issued and remain valid if there is evidence that the drug or vaccine is effective in diagnosing, treating, or preventing the coronavirus; the potential benefits of the COVID-19 drug or vaccine outweigh the risks; and there is no available or not enough alternatives to the drug or vaccine.

No unregistered COVID-19 drug and vaccine may be manufactured, sold, imported, exported, distributed or transferred without an EUA, outside of clinical trials or Compassionate Special Permits.

Vaccines from China's Sinovac Biotech Ltd. and Russia's Gamaleya Research Institute of Epidemiology and Microbiology could possibly be procured as early as the first quarter of 2021.

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