ARTA directing swift approval of pending FDA applications

The FDA has attributed the backlog to the ballooning number of applications while the number of product evaluators for the period roughly remained the same.

The Anti-Red Tape Authority (ARTA) on Monday said it ordered the Food and Drug Administration (FDA) to approve applications for the automatic renewal of certificates of product registration (CPR) and licenses to operate (LTO) that still pends at the agency.

While the total backlog at the FDA number as much as 20,000 applications for drug products alone, ARTA said it plans to order the automatic approval of 2,083 drug applications. These are the applications that the FDA received in the first eight months this year alone.

“We will be releasing the directive. We won’t be skipping technical evaluations but if it’s just paperwork, or it has been certified by the FDA before, we would be ordering whatever we could order to be automatically approved,” ARTA director general Jeremiah Belgica told reporters at the sidelines of an ARTA-FDA meeting in Makati on 2 September.

“That’s the direction. Because it’s just paperwork. But the field officers should continue the inspection…If we see in the post-evaluation that what the firms submitted is wrong, then they will be held accountable in law. (They) could also be persecuted for perjury,” Belgica added.

The plan to issue a directive developed after the ARTA received complaints from groups and individuals over the FDA’s continued failure to process its mounting backlog. ARTA said the majority of the total pending applications at the FDA were for CPR and LTO. Automatic renewals comprised the bulk of the backlog that dates back to 2015.

The FDA attributed the backlog to the ballooning number of applications for which its manpower had a hard time catching up as the number of product evaluators for the period roughly remained the same.

The ARTA said it recommends for the FDA to shift to digital processing and reduce the regulations that aren’t needed without impairing public health and safety.

Under Republic 11032, or the Ease of Doing Business (EDB) and Efficient Government Service Delivery Act of 2018, Belgica said automatic renewals under the FDA should be classified as a “simple transaction,” since it only requires standard ministerial action from the agency.

The EODB law aims to cuts down the processing time for government transactions to three working days for simple transactions, seven working days for complex transactions, and 20 working days for transactions requiring highly technical assessment.