THE Anti-Red Tape Authority (ARTA) said that it will recommend to the Food and Drug Administration (FDA) to make pre-assessment a part of the 3-7-20 standard processing time.
“We just had our workshop. So the next step is we will write to the FDA to tell them that pre-assessment should be part of the standard processing time,” ARTA Secretary Ernesto V. Perez told reporters on the sidelines of a European Chamber of Commerce of the Philippines Luncheon Meeting on Wednesday.
He said that there have been many complaints concerning the FDA, specifically on the assessment and evaluation level.
“The FDA director general has also asked us to work on it and address it. In fact, we have already issued show-cause orders to these evaluators because there are really a lot of pending applications and delays that are not being acted upon,” he said.
“So we are waiting for their response to the show-cause orders,” he added.
He said that the concerns in the FDA need immediate action, as it is critical to the country’s public health system.
“They say that they (the evaluators) are not yet subject to the automatic approval because it is still in the pre-assessment stage, so the 3-7-20 standard processing time does not apply yet,” he said.
“So what we did in the last two days, we had a workshop with them and addressed the issue once and for all on the issue of pre-assessment. We will be recommending to the FDA to include the pre-assessment in their process and shouldn’t be separated,” he added.
Under the Ease of Doing Business (EoDB) Act, simple transactions should be completed within three working days, complex transactions within seven, and highly technical transactions within 20.
He said that pre-assessment should only take three days, adding that if more days are needed for more technical transactions, this should be declared in the agency’s citizen’s charter.
“It should be declared in your citizens’ charter that that is a part of your process that you’re rendering. Meaning, in the end-to-end process that the FDA is rendering, the pre-assessment stage should be part of that process,” he added.
As of Jan. 30, ARTA received 25,197 complaints and concerns, of which 24,932 were resolved or referred, reflecting a 98.95% resolution rate. — Justine Irish D. Tabile