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Philippines FDA: Guidance Reliance for Regulatory Decisions & Regulatory Response on National PHE

Recently on 25th November, 2022 Philippines Food and Drug Administration (FDA) released two draft guidelines for comments i.e; "Guidelines Prescribing the Principle of Reliance for Regulatory Decisions of the Food and Drug Administration" and "Guidelines on Food and Drug Administration’s Regulatory Responses During Declared National Public Health Emergencies".

Reliance is defined by the World Health Organization as “the act whereby the regulatory authority in one jurisdiction takes into account and gives significant weight to assessments performed by another regulatory authority or trusted institution, or to any other authoritative information, in reaching its own decision. The relying authority remains independent, responsible, and accountable for the decisions taken, even when it relies on the decisions, assessments, and information of others.”

This guide aims to:

A. Expedite the submission and/or evaluation of authorization applications towards their timely approval;

B. Make greater efficiency to the regulatory process by eliminating duplicative work, strengthen regulatory systems, and optimize resource utilization with a focus on value-added activities without sacrificing product quality, safety, or efficacy; and

C. Optimize innovative and more effective forms of international collaboration or measures by use of available resources/expertise to aid the FDA to address emerging concerns and to be abreast with internationally acceptable norms and standards.

The reliance procedures shall apply, among others, to the registration and marketing authorization, Good Manufacturing Practice (GMP) Inspections, Clinical Trial, Vigilance and Quality Control (laboratory testing).

As a result of this Order, the President has the authority to either suspend or streamline the Food and Drug Administration's requirements for licensing, registration, certification, and other authorizations that cover health products and establishments, or to streamline and expedite the process as specified in this order.

This guideline shall apply to FDA Centers/Offices and concerned stakeholders with respect to applications for licensing, registration or other required authorizations.


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