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Published May 11, 2021, 3:57 PM
The Anti-Red Tape Authority (ARTA) has issued a show-cause order to a Food and Drug Administration (FDA) office for sitting on over 600 drug applications filed since 2014 despite completeness of submission of various pharmaceutical companies.
ARTA Investigation Enforcement and Litigation Director Jedrek Ng on Tuesday, May 11, ordered FDA Center for Drug Regulation and Research (CDRR) Director IV Jesusa Cirunay to “explain why no administrative or criminal case should be filed” against her.
ARTA’s action stemmed from the 23 affidavits of several pharmaceutical companies detailing the alleged delays committed by FDA-CDRR on their applications filed as far back as 2014 or so.
FDA official asked to explain 600 pending drug applications
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Metro Manila (CNN Philippines, May 11) – The Anti-Red Tape Authority issued on Tuesday a show-cause order against a Food and Drug Administration official for 600 drug applications pending in her office.
ARTA ordered FDA Center for Drug Regulation and Research (FDA-CDRR) Director Jesusa Cirunay to explain why the drug applications remain pending despite the complete submission of requirements by involved pharmaceutical firms.
The complaint stemmed from the 23 affidavits of several pharmaceutical companies which detailed the alleged delays committed by FDA-CDRR on their applications filed since 2014.
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By JULIA MARI ORNEDO, GMA News
Published May 10, 2021 12:39pm The Department of Health (DOH) on Monday said it will file an application for emergency use authorization (EUA) of the coronavirus vaccine developed by Chinese firm Sinopharm. “The reason why we are doing this is merong posibilidad na magiging government to government ang transaksyon o negotiations for Sinopharm (there is a possibility that the negotiations for Sinopharm will be government to government),” Health Undersecretary Maria Rosario Vergeire said in an online briefing. “This is something that we do so that we can facilitate the process of receiving vaccines but of course everything undergoes the strict regulatory process,” she added.