FDA unveils online service for issuance of license to operate

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The Food and Drug Administration (FDA) has unveiled its online service portal for the issuance of the license to operate (LTO) and would soon launch the e-registration system for the certificate of product registration (CPR).

Dr. Oscar G. Gutierrez Jr., OIC-director of the FDA’s Policy and Planning Service, said the agency’s Center for Drug Research and Regulation has recently launched the e-services portal for LTO applications of drugstores, retail outlets for non-prescription drugs (RONPDs), drug exporters, importers, wholesalers and drug traders.

The “Pilot Implementation of FDA eServices Portal for License to Operate (LTO) Application for Drugstores, RONPD, Drug Distributor, and Drug Traders” is being undertaken under FDA Advisory No. 2020-781.

All the other FDA centers, including devices and cosmetics, will also be included in the e-services portal. Stakeholders in the National Capital Region who intend to apply for a license to operate as drug distributor, drug trader, and drugstore or retail outlet for RONPD are invited to use the FDA eServices Portal.

The maximum processing time of the e-LTO is within the requirement of the Anti-Red Tape Act (ARTA) of less than 20 days compared to one to three months previously.

The e-license to operate covers initial applications, renewals, variations and changes in office location, product labeling and others.

“The license to operate (LTO) will be printed by the applicant at the convenience of their home. There will be no more mailing or even coming to FDA just to receive your LTO,” said Gutierrez.

Currently, the processing of the certificate of product registration (CPR) for food products would take about 114 days, but under the e-registration system, the maximum processing time will be 20 days in compliance with ARTA.

E-registration for drugs will also be implemented within the year. As with the LTO, the CPR is to be printed by the applicants from their homes or offices.

As for the e-notification for medical devices, the FDA plans to make revisions taking lessons from the COVID experience. Also in the pipeline is an e-LTO for manufacturers, slated for the third quarter of 2020, Gutierrez said.

Businesses, particularly micro, small and medium enterprises (MSMEs), have long made known their struggles with the challenges and delays in getting the FDA’s mandatory LTO and CPR, a situation they said hindered their growth.

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