MANILA – After the Anti-Red Tape Authority (ARTA) issued a show-cause order against the Center for Drug Regulation and Research (CDRR) under the Food and Drug Administration (FDA), some 408 drug applications were automatically approved.
“In her explanation as full compliance of the show-cause order, Jesusa Joyce N. Cirunay, Director IV of the FDA Center for Drug Regulation and Research (CDRR), said they have processed 408 out of 412 AR (automatic renewal) applications,” the ARTA said in a statement Wednesday.
It cited Cirunay saying the four remaining applications are pending as two were not submitted by the client while the other two were re-routed to other centers or units.
The ARTA issued a show-cause order to Cirunay dated May 11, 2021 after it received 23 affidavits from several pharmaceutical firms that CDRR has yet to approve their renewal even though some of the applications were filed about seven years ago.
“Ambica International Corporation's application that was received by the drug center on 2 February 2017, was only approved on 28 May 2021 -- almost 1,576 days or four years, three months, and 26 days from its date of application,” ARTA said.
Under the implementing rules and regulations of the Republic Act 11032, or the Ease of Doing Business and Efficient Government Service Delivery law, government agencies are given three working days to process simple transactions, seven working days for complex transactions and 20 working days for highly technical transactions.
ARTA director general Jeremiah Belgica earlier said such renewal applications fall under simple transactions and should be processed within three working days.
“The Authority is now evaluating FDA CDRR's reply before recommending an appropriate action,” the agency said.
Cirunay was given until May 31 to explain to ARTA why no administrative and criminal charges should be filed against her.
“The Authority is calling on the public to submit affidavit complaints if they have any pending applications with other government agencies,” it added. (PNA)
