(Total Views: 529)
Posted On: 01/11/2021 7:44:22 PM
Post# of 154091
It took two weeks for me to hear back from the Philippines FDA, but this is their response to my question about whether or not they require a prior EUA from the origin country. I was hoping that they would confirm my reading and understanding of their circular, but instead they merely recited the circular's relevant language back to me. So, it seems clear that a covid EUA from the US FDA for Leronlimab is required prior to obtaining (and perhaps is required prior to filing an application for) a Philippines EUA. I note that Article VI (c) (4) of the circular requires a list of prior EUAs.
From: CDRR OD <cdrr.od@fda.gov.ph>
Cc: Food And Drug Action Center <fdac@fda.gov.ph>
Sent: Monday, January 11, 2021, 2:35:41 AM EST
Subject: Re: Question About Circular 2020-036
Dear Sir/Madam,
As stated in FC 2020-036:
"This Circular shall apply to the pharmaceutical industry and government entities such as the national procurer or health program implementors intending to apply for an EUA for drugs and vaccines for COVID-19, and shall pertain only to unregistered (anywhere in the world) drugs and vaccines for prevention, diagnosis and treatment of COVID-19 and granted an EUA by the National Regulatory Authority (NRA) of the country of origin or any other mature and established NRA as identified by FDA."
Thank you.
Food and Drug Action Center
Food and Drug Administration
Civic Drive, Filinvest City
Alabang, Muntinlupa PH
Forwarded message
Date: Sun, Dec 27, 2020 at 3:49 AM
Subject: Question About Circular 2020-036
To: fdac@fda.gov.ph <fdac@fda.gov.ph>
Hello, in order for a foreign drugmaker to apply in the Philippines (pursuant to Circular 2020-036) for an EUA for a Covid-19 drug therapy (Not a vaccine), is it a prerequisite that the drugmaker be first granted an EUA for that therapy from its country of origin? Thank you.
From: CDRR OD <cdrr.od@fda.gov.ph>
Cc: Food And Drug Action Center <fdac@fda.gov.ph>
Sent: Monday, January 11, 2021, 2:35:41 AM EST
Subject: Re: Question About Circular 2020-036
Dear Sir/Madam,
As stated in FC 2020-036:
"This Circular shall apply to the pharmaceutical industry and government entities such as the national procurer or health program implementors intending to apply for an EUA for drugs and vaccines for COVID-19, and shall pertain only to unregistered (anywhere in the world) drugs and vaccines for prevention, diagnosis and treatment of COVID-19 and granted an EUA by the National Regulatory Authority (NRA) of the country of origin or any other mature and established NRA as identified by FDA."
Thank you.
Food and Drug Action Center
Food and Drug Administration
Civic Drive, Filinvest City
Alabang, Muntinlupa PH
Forwarded message
Date: Sun, Dec 27, 2020 at 3:49 AM
Subject: Question About Circular 2020-036
To: fdac@fda.gov.ph <fdac@fda.gov.ph>
Hello, in order for a foreign drugmaker to apply in the Philippines (pursuant to Circular 2020-036) for an EUA for a Covid-19 drug therapy (Not a vaccine), is it a prerequisite that the drugmaker be first granted an EUA for that therapy from its country of origin? Thank you.
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