President Rodrigo Duterte has granted the head of the Food and Drug Administration (FDA) the authority to issue emergency use authorization (EUA) for COVID-19 vaccines and drugs in the Philippines.
Executive Order No. 121 released on Wednesday stated that the Director General of the FDA has power “to implement reliance and recognition processes for emergency use of drugs and vaccines” in evaluating EUA applications and “may accept the regulatory decision” of “established regulatory authorities” like WHO and US-CDC.
Health Secretary Francisco Duque III earlier said on November 17 in a recorded address of the President that the EUA will “cut the processing time from six months to about 21 days.”
The issuance of EUA are subject to conditions such as the effectivity of the drug and vaccine “to prevent, diagnose or threat COVID-19”, its potential benefits “outweigh the known and potential risks”, and “if there is no adequate, approved and available alternative”.
The FDA and other concerned agencies are likewise directed to “conduct post-authorization monitoring” of the deployment of the product, more relevant information, and manufacturer status “concerning full-product life-cycle”.
The FDA earlier explained that priority sectors for vaccine distribution will not automatically be altered through an EUA.
President Duterte has always emphasized that health and other essential workers and the “poorest of the poor” will be prioritized for inoculation. – PTV News Online
