Philippines FDA to speed up Covid-19 clinical trial approval decisions by 50 per cent
Filipino regulatory authority publishes guidance on how to balance compliance and speed of clinical trail approvals
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The Philippine Food and Drug Administration (FDA) has released guidance for clearer, simpler and more transparent regulation around the conduct of Covid-19 clinical trials in Asia.
Targeting consolidation of Covid-19 treatment and vaccine trial processes for clinical trial sponsors, contract research organizations and clinical investigators, the report highlighted the FDA’s aspirations to process clinical trial requests for Covid-19 therapeutics within 30 days and vaccines within 40 days, compared to the standard 60-day review workflow.
A total of five Covid-19 clinical trial sites in the Philippines have been said to be active by ClinicalTrail.gov, with Janssen Pharmaceutical Companies of Johnson & Johnson’s 60,000-subject Phase 3 study of the Ad26.COV2.S vaccine among the list.
Alex Gorsky, chairman and CEO of Johnson & Johnson, said: “As Covid-19 continues to impact the daily lives of people around the world, our goal remains the same – leveraging the global reach and scientific innovation to help bring an end to this pandemic.
“Bringing together scientific minds, and rigorous standards of safety, in collaboration with [global] regulators, to accelerate the fight against this pandemic, this pivotal milestone demonstrates our focused efforts toward a Covid-19 vaccine that are built on collaboration and deep commitment to a robust scientific process,” he added.
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