PRESIDENT Rodrigo Duterte has issued an executive order authorizing the director general of the Food and Drug Administration (FDA) to issue an emergency use authorization (EUA) for Covid-19 drugs and vaccines.
Executive Order No. 121, which Duterte signed on Tuesday, December 1, 2020, will take effect immediately after publication.
An EUA will be valid only for the duration of the public health emergency due to coronavirus disease 2019 (Covid-19).
Duterte declared a state of public health emergency in the entire country at the start of the epidemic in February 2020.
Under EO 121, the FDA director general is given the power to implement reliance and recognition processes for the emergency use of drugs and vaccines.
He may accept the regulatory decision of the World Health Organization (WHO), United States Centers for Disease Control and Prevention (CDC) or other international recognized regulatory body.
The FDA will convene a panel of experts on drug and vaccine development, which will review data on the safety and efficacy of a drug or vaccine with an EUA application. This panel of experts will submit its recommendation to the FDA director general.
The directive also requires FDA and the Department of Health (DOH) to conduct post-authorization monitoring to track product deployment, additional relevant information and the full life cycle of the product.
The holder of an EUA, meanwhile, will be required to provide comprehensive data on its product’s benefit-risk balance.