Charmaine Roson - Philippines

The PFDA has issued guidelines stream-lining the process flow for emergency response, ensuring a smoother situation during future public health emergencies.”

Charmaine Roson
Principal Consultant
Asia Actual Philippines

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Philippines FDA to Implement New Guidelines to Respond to Future National Health Emergencies

Published on: February 7th, 2023

The Philippines FDA has issued a new report entitled “Guidelines on the Food and Drug Administration’s Regulatory Responses During Declared National or State Public Health Emergencies.” The new guidelines are being put in place to capitalize on the hard lessons learned during the COVID-19 pandemic to ensure a timely and effective response to future large-scale public health emergencies and crises by creating a set of new protocols. The update from the Philippines FDA on National Health Emergencies can be found on their website here. 

If you have questions about the new guidelines or their impact on your compliance in the Philippines contact us here. 

Advisory Process Flow for PFDA Emergency Response

The following process flow showcases the guidelines from the Philippines FDA on necessary public health emergency response:  

  • Within a 24-hour period of the initial declaration of a national public health emergency, the Director General must convene the PFDA Crisis Management Committee and create a task force (composed of the necessary centers/offices, given the situation).  
  • Guidelines must be issued no longer than 15 days after the initial issuance of the national public health emergency. Guidelines or rules issued will take effect as long as the emergency is in place.  
  • The Director General of the PFDA must provide budgetary provisions that ensure the efficient deployment of resources.  
  • In order to ensure effective communication, the task force will initiate meetings with its internal and external stakeholders.  
  • The emergency task force will provide all updates, reports and recommendations to the crisis management committee. This committee will then endorse a recommendation and present it to the director general.  
  • Finally, the director general must submit a report to the PFDA president (through the DOH secretary). 

The Philippines FDA will be implementing these protocols as draft guidance. Secondarily interested parties have until this date to comment: February 28th, 2023. Comments should be sent to: pps@fda.gov.ph. 

In Case You Missed It

This comes just a few weeks after a different update from the Philippines FDA, where they issued an advisory reiteration in regards to unethical business practices, the details of which can be found in our blog on the subject here. 

Grow With Us

Please contact us if you have questions regarding the new regulations and/or are interested in registering your product in the Philippines. Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today with any questions or support requests. 

Asia Actual is a regulatory consulting company focused on helping manufacturers grow sales in challenging Asia markets through independent license holding, direct fulfillment, and a variety of sales channel support services.   

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