If your business in the Philippines involves importing, distributing, or selling food, beverages, pharmaceuticals, cosmetics, children’s toys, or medical devices, you must obtain a License to Operate (LTO) and Certificate of Product Registration (CPR) from the Food and Drug Administration (FDA).
What is the Philippine FDA?
The Food and Drug Administration (FDA) is the regulatory authority overseeing food, drugs, cosmetics, medical devices, and related products in the Philippines. Its mission is to approve, supervise, and manage products entering the Philippine market, ensuring compliance with national standards to protect consumer health and safety.
The FDA is organized into four regulatory centers, each managing specific product categories:
Center for Food Regulation and Research (CFRR): Oversees food and beverage products
Center for Drug Regulation and Research (CDRR): Oversees pharmaceuticals, veterinary drugs, pesticides
Center for Cosmetics and Household Regulation (CCRR): Oversees cosmetics, vaping/heated tobacco products, toys, household goods
Center for Device Regulation, Radiation Health (CDRRHR): Oversees medical devices and equipment
Any company dealing with products under these centers must obtain both LTO and CPR before selling in the Philippines.
1. License to Operate (LTO)
LTO Classification:
LTO licenses are classified based on business activities, including import/export, wholesale trade, transportation, and manufacturing. The application requirements vary depending on the business type.
Typical LTO Application Documents:
Signed application form
Company documents: SEC/DTI registration, articles of incorporation, joint undertaking, business license, lease contract, site and vicinity layout
Product list, distribution agreements, product-related certifications (as applicable)
Other supporting materials: warehouse proof for import/export, vehicles/equipment proof for transportation, lab/factory documents for manufacturing
Special Note:
For certain products, a qualified professional (e.g., pharmacist or other licensed expert) must sign the application. For veterinary products, a licensed veterinarian may also sign. The responsible professional must hold a valid Philippine license and provide proof of FDA training participation.
LTO Timeline:
Processing: ~6–10 weeks
Initial validity: 2 years
Renewal: 5 years
Renewal must be submitted 90 days before expiry; failure may result in business suspension or license cancellation
2. Certificate of Product Registration (CPR)
After obtaining the LTO, each product must be registered with the FDA to receive a CPR.
CPR Application Documents:
Complete product list
Distribution agreement between manufacturer/supplier and importer
Technical specifications for raw materials and finished products
Material list and finished product list (representative sample)
Laboratory test reports (functional/performance data, risk analysis, and control measures; pharmacist may issue)
Labeling materials (mock-up labels)
Representative sample (if required)
Additional Requirements:
For products in plastic containers: migration/leachability test certificates
For imported pharmaceuticals: Certificate of Pharmaceutical Product (CPP) or foreign regulatory clearance
For new veterinary drugs: preclinical studies and release monitoring plan
For fixed-dose combination products: rationale for combination
Valid business license (importer/manufacturer/distributor/trader)
CPR Timeline:
Processing: ~15–30 weeks
Initial validity: 3 years
Renewal: 5 years
Key Takeaways
Product compliance and certification are essential for any business. Only certified products can be legally marketed, distributed, and sold in the Philippines.
Different products require different documents and processing timelines
Obtaining LTO and CPR ensures legal operation and opens business opportunities
Professional guidance helps navigate Philippine regulatory processes efficiently
For Chinese or foreign enterprises seeking FDA guidance, consultation services are available. With nearly 10 years of experience in the Philippines, we provide professional advice, anticipate potential issues, and assist with all regulatory requirements.
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