The Food and Drug Administration (FDA) License to Operate (LTO) is a legal requirement for businesses in the Philippines that handle food, drugs, cosmetics, and medical devices. With key updates to the application and renewal processes introduced in 2025, business owners and management must understand these changes to stay compliant and avoid disruptions in their operations.
What is an FDA License to Operate
The FDA License to Operate (LTO) is a mandatory authorization for businesses involved in regulated industries. It ensures adherence to safety and quality standards to protect public health.
Here’s what you need to know:
- Purpose: Required for manufacturing, importing, exporting, distributing, or selling regulated products like food, drugs, cosmetics, or medical devices.
- Validity: Typically valid for 3–6 years, depending on the business type.
- Consequences of Non-Compliance:
- Penalties
- Product seizures
- Operational shutdowns
- Key Requirements: The submission of detailed documentation, facility inspections, and compliance with Good Manufacturing Practices (GMP) or other standards are required. In the application section, we have provided a list of initial application requirements.
2025 FDA LTO Renewal and Application Updates
The FDA introduced several updates to the License to Operate (LTO) process between late 2024 and mid-2025. Below is a simplified breakdown of the key changes and when they took effect:
- New LTO Validity Periods
The FDA now grants LTOs valid for up to 12 years, depending on the business size and whether the application is new or a renewal. These changes were outlined in AO No. 2024-0015, issued on November 27, 2024.
- Mandatory Use of e-Services Portal
All LTO applications must now be submitted through the FDA e-Services Portal using a single official email to streamline communication, including for HUHS (Household/Urban Hazardous Substances) establishments. This requirement for HUHS businesses was enforced starting June 2, 2025, via Advisory No. 2025-0512.
- End of the 180-Day Early Renewal Window
Businesses can no longer renew their LTOs 180 days before expiration. The early renewal policy was officially lifted on July 8, 2025, per Advisory No. 2025-0095-A.
- Reinstatement of the 90-Day Renewal Period
The renewal window has reverted to the original 90 days before expiry, effective July 8, 2025, aligning with the end of the early renewal policy.
- Surcharges for Late Renewal
Late renewals are now penalized with double the renewal fee, plus an additional 10% per month of delay. Under the same advisory, this rule began enforcement on July 8, 2025.
New FDA LTO Application Process
The 2025 application process is now entirely digital, leveraging the FDA’s e-Portal 2.0 for a streamlined experience. Follow these steps for a successful application:
- Online Registration:
- Create an account on the FDA e-Portal 2,0
- Ensure accurate business details.
- Upload the Required Documents, Which Include:
- Application Form
- Proof of Business Name Registration (DTI/SEC Certificate)
- Business Permit
- Proof of Income
- Risk Management Plan (RMP), which shall be required for medium and large food manufacturers, traders, and distributors (importer, exporter, and/or wholesaler)
- Site Master File (SMF), which shall be required for applicants applying for LTO as manufacturers of large and medium-sized food manufacturers (CFRR)
- Food Business Operators shall ensure that food satisfies the requirements of food law and that control systems are in place.
- There are basic documentary requirements specifically for the food sector. Depending on your business, industry, and products, the FDA may request other supporting documents.
- Pre-Assessment:
- FDA reviews submissions within 10 working days, as AO No. 2024-0015 specified.
- Incomplete applications are returned with feedback.
- Inspection:
- Usually, on-site inspection is conducted for new applicants, especially manufacturers.
- Focus on compliance with safety standards.
- Payment and Approval:
- Pay fees via the e-Portal’s integrated payment system.
- LTO issued electronically. Processing time depends on the length of the inspection, but the entire process typically lasts 3-4 weeks. Incomplete or inaccurate documents may cause delays.
Business Registration Philippines can assist you with securing the documentary requirements and filing with the FDA. We’ll ensure your application is complete, accurate, and compliant to avoid delays.
Revised FDA LTO Renewal Procedures
For existing LTO holders, the 2025 renewal process introduces stricter timelines and enhanced compliance measures. Here’s what’s new:
- Extended Submission Window:
- Renewals must be submitted 90 days before expiration
- Late submissions may result in:
- Penalties
- Temporary suspension
- Updated Documentation:
- Submit:
- Accomplished e-Application Form with Declaration of Undertaking
- Updated GMP certificates
- Revised product lists
- Proof of compliance with 2025 regulations
- Payment of Fees
- Submit:
- Online-Only Process:
- All renewals are handled via e-Portal 2.0, eliminating paper submissions.
- Compliance Audits:
- Random audits for high-risk businesses (e.g., pharmaceutical manufacturers).
- Focus on adherence to updated safety and quality standards.
- Faster Processing:
- Complete submissions are processed more efficiently.
Final Thoughts
The 2025 FDA LTO updates mark a shift toward a more efficient, digital-first regulatory process in the Philippines. While the online-only system and stricter timelines may require adjustment, they offer benefits like:
- Reduced processing delays
- Improved transparency
- Alignment with global standards
Although convenient, online application offers limited direct assistance from the FDA. Contact Business Registration Philippines to help you gather the requirements and navigate the application process.
Are You Applying for or Renewing Your FDA License to Operate?
Securing all your business’s legal requirements can be a complex and challenging process. With numerous permits and licenses required by different government agencies, it’s easy to miss a document or forget to renew it. Unfortunately, this can lead to costly fines or even force your operations to shut down.
Thankfully, the Business Registration Philippines team provides comprehensive support for your business registration, so you don’t have to stress over the paperwork. We’ll handle the applications and renewals so you can focus on what matters most—running your business and achieving financial success.
Contact us today to schedule an initial consultation with one of our experts:
- Contact Us Here
- Fill Out the Form Below
- Call us at +63 (02) 8540-9623