FDA targets full automation of application processing by end-2021

The Food and Drug Administration (FDA) said it has launched the pilot implementation of fully automated e-services systems that require only 14 working days to issue the License to Operate (LTO) and 20 working days to issue the Certificate of Product Registration (CPR).

Dr. Oscar G. Gutierrez, Jr., OIC-director of the Policy and Planning Service of FDA, explained that the current migration from a semi-automated system (https://eportal.fda.gov.ph) to a fully automated system (https://eservices.fda.gov.ph/) is meant to promote ease of doing business and contactless transactions.

Gutierrez in a recent webinar said that with the new e-LTO portal, applicants no longer need to e-mail FDA to ask for the log-in name and password for access, but can simply apply directly from the new website.

Moreover, the entire process is fully automated, including approval.

Gutierrez added that the e-LTO portal incorporates additional features such as pre-assessment and payment of fees, the latter to be accomplished through the bank.

“We are working on a MOA with the Bayad Center so that you can pay your fees through this payment scheme,” he said.

The e-portal also has checking and approval functions. Gutierrez said an application will be automatically forwarded from the checker to the next checker or evaluator “so everything is automated.”

The LTO will also be automatically emailed to the applicant. “We no longer have to mail them individually,” said the official.

He said the counting of 14 working days for processing of applications from food product establishments starts when the applicant has paid the corresponding fees.

For the period September 28 to October 12 this year, the average processing time for LTO applications via the pilot e-services portal was 12.9 calendar days, faster than the required 14 working days.

He clarified that the pilot implementation is limited only to the National Capital Region (NCR). It also covers only non-manufacturers, since an LTO e-services system for food manufacturers “will be piloted and launched soon [as] we are in the final stage of review.”

Meanwhile, on the issuance of the CPR for food products and food supplements, the agency plans to cut processing time from 114 calendar days for initial CPR applications to 20 working days under the pilot implementation of eCPR Version 2.

“In the version 2 it is again fully automated, unlike in the version 1,” said Gutierrez.

As with the LTO, the applicant no longer needs a log-in name and password.

The 20 working days for processing applications will also start once the pre-assessed corresponding fees have been paid. The CPR will then be automatically emailed to the applicant.

“Our system would automatically forward the application if the evaluator has not acted upon it for three to five days. [The application] automatically goes to the supervisor, then again if it is not acted it goes on automatically to the higher officials for approval,” said Gutierrez.

“In this way, we are able to manage and monitor and institute corrective actions along the way.”

He continued that this year, the FDA had an 80% compliance with the maximum prescribed processing time for permits and certificates under the Ease of Doing Business Act, compared to just 57% in 2019.

Next year, the agency is targeting 90% compliance as it goes fully automated and 100% compliance by 2022.

“By the end of 2021 or early 2022, FDA will be fully automated,” he assured.

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