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Published May 17, 2021, 3:43 PM
The Food and Drug Administration (FDA) was given until next week, May 24, by the Anti Red Tape Authority (ARTA) to explain for sitting down on hundreds of drug applications from various pharmaceutical companies with complete requirements since 2013.
On May 10, ARTA issued a Show Cause Order to the FDA Center for Drug Regulation and Research (CDRR) after some pharmaceutical companies filed over 20 affidavits detailing the alleged delays of the office in approving their applications that were filed as far back as 2013 or so. ARTA said these involved over 400 pending applications, mostly from Philippine pharmaceutical companies, for automatic renewal.
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.
na to di ito kumplikado. Ito yung mga aplikasyong for automatic renewal.