1. Certification Overview
The Philippines Food and Drug Administration (PFDA) is a regulatory agency under the Department of Health that ensures the safety, efficacy, or quality of health products, including food, drugs, cosmetics, medical devices, biological products, vaccines, in vitro diagnostic reagents, radiation-emitting devices or equipment, pesticides and toys, household/urban hazardous substances, or consumer products that may affect health as regulated by the FDA.
You can apply for a License to Operate (LTO), Certificate of Product Registration (CPR), and Product Notification through Philippine FDA (PFDA) certification.
A License to Operate (LTO) is required in all sectors, and Product Notification is required for cosmetics, toys, and childcare products.
2. Regulatory Agencies & Basic Information
| Regulatory Agencies | PFDA (Philippines Food and Drug Administration) |
| Management department under PFDA | CCHUHSRR (Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research) |
| Lead time | 3 weeks |
| Price | Varies by product |
| Agent | A local agent (LCR) or Marketing Authorization Holder (MAH) is required. |
3. Reporting Process
- e-portal sign-up
- Fill out application and report forms via e-portal
- Fee payment
- Verification of application accuracy (additional documents may be required if necessary)
- Final approval by Director CCHUHSRR
4. Required Documents
| Cosmetics Report | • Cosmetics Electronic Portal User Account • Valid LTO • Additional Documents 1) Product Labeling Artwork 2) Instructions for Use 3) Mechanism of Action 4) Certificate of Origin for Ingredients 5) Safety Data Sheet 6) Certificate of Analysis |
| License to Operate (LTO) | • Consolidation Application • Proof of Fee Payment • Certificate of Business Registration • Certificate of Business Address • Product List • Location Map • Floor Plan/Layout of Product Manufacturer |
5. Validity Period
- Validity Period: 1 year
- Renewal: Requires annual renewal