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Philippines FDA: Guidelines on Regulatory Reliance on the Conduct of Clinical Trials

Yesterday (3rd March 2023) the Philippines Food and Drug Administration (FDA) released an updated guideline "Guidelines on Regulatory Reliance on the Conduct of Clinical Trials".

As per the Philippines FDA the term "Reliance refers to the act whereby the regulatory authority in one jurisdiction takes into account and gives significant weight to assessments performed by another regulatory authority in its own decision."

Basically, the purpose of this Circular is to provide guidelines on the reliance for approval of clinical trial applications and to promote an efficient and effective approach to the regulation of clinical trials in the Philippines.

In particular, this Circular aims to facilitate the evaluation of clinical trial applications by relying on regulatory requirements; and improve access to investigational drug products for public health emergencies, rare diseases, and emerging and re-emerging infectious diseases.

As a result of this Circular, Sponsors, Contract Research Organizations (CRO), investigators, and Research Ethics Committees (REC) are required to use all phases of Multi-Regional Clinical Trials (MRCTs) involving investigational drug products intended to be registered and marketed for public health emergencies, rare diseases, emerging and reemerging infectious diseases of public health threats.

To know more in detail on the application process and requirements, click this LINK.


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