Philippines: Comprehensive Framework for FDA LTO Application of Covered Health Product Establishments

On 22nd November 2024, the Department of Health of the Republic of the Philippines issued Administrative Order No. 2024-0015, aiming to update the rules and procedures for applying the initial, renewal, and variation Licenses to Operate (LTO) through the FDA eServices Portal System. It also seeks to align with international standards and local regulations to improve LTO application processes and utilize information and communication technology to enhance risk focus, coordination, and information sharing. Additionally, the order aims to extend the validity period of licenses and establish an administrative reconsideration mechanism within the regulatory licensing processes.

Under Specific Guidelines, four establishments are mentioned and shall comply with the stipulated conditions accordingly: Pharmaceutical Establishments, Cosmetic/HUHS Establishments, Food Business Operators (FBOs), and Medical Device Establishments.

Medical Device Establishments

• Establishments that are considered manufacturers of medical devices and require a License to Operate (LTO) include:

  • Hospitals or establishments engaged in the 3D printing of medical devices

  • qOptical establishments assembling optical lenses and frames

  • Dental laboratories engage in the manufacture of custom-made dental devices

• Establishments handling “For Research Use Only” medical devices must obtain an LTO from the FDA as a Medical Device Distributor-Importer.

  
  

All establishments must have at least 1 Qualified Person, to ensure all documentary and technical requirements and information provided in the application are correct.

Application Procedure

Validity of the LTO

• Major and Minor Variations: The validity period of approved major and minor variations will extend to the end of the current LTO’s validity period, starting from the approval date

• CPR/CPN: The FDA will determine the validity period of CPR/CPN for establishments with valid LTOs through appropriate regulations. This period will not exceed the current LTOs’ validity

• Fees: LTO and CPR/CON fees are calculated annually and multiplied by the number of valid years, as determined by the previous paragraph

  
  

Renewal Applications

• Automatic Renewal

An application for automatic renewal shall be filed through the eServices Portal System made within 90 (ninety) calendar days before the expiration of the validity date of the LTO

• Regular Renewal

An application for renewal shall be filed through the eServices Portal System within 90 (ninety) calendar days before the expiration of the validity date of the LTO

Conclusion

Administrative Order No.2024-0015 streamlines the FDA licensing process in the Philippines by enhancing efficiency, aligning with international standards, and leveraging technology for improved regulatory oversight. The order introduces extended license validity, an administrative reconsideration mechanism, and clearer compliance guidelines for Pharmaceutical, Cosmetic/HUHS, Food Business Operators (FBOs), and Medical Device Establishments, ensuring a more robust and coordinated licensing system.

Source: Food and Drug Administration (FDA)