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 approvalsAdd bookmark
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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