The Anti-Red Tape Authority (ARTA) has instructed the Food and Drug Administration (FDA) to address half of its backlog of 11,000 applications for certificates of product registration within 11 days, starting Tuesday.
ARTA Director General Jeremiah B. Belgica told FDA in a meeting that ARTA will automatically approve low-risk products, which consist of 40-50% of pending registrations, if they are not processed within that period.
The bulk of pending applications are with FDA’s Center for Food Regulation and Research.
The FDA was given three days from Tuesday to assess its internal processes and information technology capacity to move the applications forward. The remaining seven to eight days was allotted to application processing.
ARTA in September automatically approved 3,125 pending applications for automatic renewal.
FDA Center for Food Regulation and Research Director Pilar Marilyn P. Pagayunan said that the slow approvals were due to lack of manpower and IT infrastructure.
Ms. Pagayunan noted that identifying low-risk products from the applications is manual. Mr. Belgica said that ARTA will send an IT representative to the FDA to help the agency examine its digital classification of records.
“We’ll give you three days to please figure it out. It will be a disappointment if it is not addressed by Friday,” Mr. Belgica said.
Low-risk food products for FDA registration, according to a 2016 circular, include certain fats, oils and fat emulsions; processed fruits; vegetable and edible fungi; confectionery; cereal-based products; processed meat and meat products; and bakery wares, among others.
Requirements for a certificate of product registration include a license to operate, proof of payment, an accomplished e-registration form, a picture of the label, samples (for food supplements), and justification of claims and scientific studies.
Applicants for low-risk products are not always required to submit scientific studies if there are no nutritional claims, FDA said.
“I would assume the scientific studies would be the ones that take time, because all of the others would basically be ministerial,” Mr. Belgica said.
FDA said it also evaluates labelling to monitor compliance with guidelines on nutrition information, allergen information, and ingredients lists.
Asked if he has concerns about the risk to the public if ARTA automatically approves products, Mr. Belgica said in an interview after the meeting that “If it’s low-risk, it’s already cleared. They’re just looking at the labels.”
“I’ve been pre-clearing it with them — are these products still up for testing whether it’s viable… I think it’s no longer the problem. So we’ll make sure in those orders we come up with that tapos na ‘yung testing, na-certify na (the testing and certification is complete).”
Meanwhile, ARTA also directed all government agencies to submit their lists of pending contracts by Dec. 9 following President Rodrigo R. Duterte’s directive.
In a statement Tuesday, ARTA said that Mr. Belgica and ARTA Deputy Director General Ernesto Perez signed a memorandum circular that applies to all government offices and agencies in the executive department, including local government units and government-owned or controlled corporations. — Jenina P. Ibañez
Source: https://www.bworldonline.com/arta-sets-deadline-for-fda-to-clear-backlog/