Philippines Considers Regulatory Reliance To Speed Up Evaluating Trial Applications

23 May 2022

The Philippines FDA is looking to leverage the work conducted by “stringent” regulators when it comes to reviewing certain clinical trial applications.

FDA Philippines Wants To Streamline Its Clinical Trial Approval Processes • Source: Shutterstock

The Philippines Food and Drug Administration is inviting stakeholder feedback on a proposed abridged process for evaluating applications to conduct certain clinical trials by relying on approvals granted for these studies by a “stringent” regulatory authority.

The reliance process would apply to clinical trials targeting public health emergencies, rare diseases, cancer, HIV/AIDS or emerging or re-emerging...