License to Operate
- Business permit or barangay clearance
- SEC or DTI registration
- ID of the authorized person
- Existing LTO (renewals and amendments)
FDA registration in the Philippines
Manufacturing, importing, distributing or selling food, drugs, cosmetics or health products? You'll need approval from the Food and Drug Administration of the Philippines. Our FDA specialists prepare and file your application and follow it through to approval.
LTO& product registration
Food · Drugs · Cosmeticscovered
PHP5,000service fee, from
How FDA approval works
Most businesses need two things: a License to Operate (LTO) for the company, then product registration for each item they sell. We evaluate and compile your documents, correct them to FDA guidelines, submit them, pay the FDA fees on your behalf and follow up until you receive approval.
Every price below has two parts: our service fee, and the FDA fee paid to the government.
Fees & timelines
Every application, priced up front
Timelines are maximums set by FDA processing. All amounts in PHP.
| Application | Timeline | Service fee | FDA fee |
|---|---|---|---|
| Initial | 2–3 months | 8,000 | Drugs 5,000 · Food 4,000 · Cosmetics 3,000 |
| Renewal | 2–3 months | 5,000 | Drugs 5,000 · Food 4,000 · Cosmetics 3,000 |
| Amendment, notification or variation | 2–3 months | 5,000 | 1,000 |
| Application | Timeline | Service fee | FDA fee |
|---|---|---|---|
| Initial (low, medium, high risk, raw materials) | 3–4 months | 20,000 | Low 1,000 · Medium 1,000 · High 2,000 · Raw materials 500 |
| Renewal | 2 months | 8,000 | Low 1,000 · Medium 1,000 · High 2,000 · Raw materials 500 |
| Amendment, notification or variation | 1 month | 8,000 | 500 per amendment type |
| Application | Timeline | Service fee | FDA fee |
|---|---|---|---|
| Initial, prescription (Rx) | 24–36 months | 28,000 | 15,000 |
| Initial, OTC / household remedy | 8–16 months | 20,000 | 15,000 |
| Automatic renewal, Rx | 2–4 months | 8,000 | 10,000 |
| Automatic renewal, OTC / household remedy | 2–4 months | 8,000 | 10,000 |
| Application | Timeline | Service fee | FDA fee |
|---|---|---|---|
| PIC/S manufacturer, desktop evaluation | 3–6 months | 16,000 | 10,000 |
| Non-PIC/S manufacturer, plant inspection | 12–24 months | 16,000 | 10,000, plus inspection costs |
| Application | Timeline | Service fee | FDA fee |
|---|---|---|---|
| Cosmetic product | 3–4 months | 12,000 | 2,000 |
Requirements
What to prepare
We'll confirm the exact list for your application. These are the usual starting points.
Food products
- Importer's License to Operate
- WHO GMP, ISO, FSC or purchase order
- Finished goods certificate of analysis
- Label artwork and product image
- FDA eportal account
Cosmetic products
- License to Operate
- Manufacturer's license
- Unit dose and formulation
- Finished goods certificate of analysis
- Image of the finished product
Drug product registration needs the manufacturer's GMP application first; we'll share the full requirements separately. Foreign manufacturer GMP applications need apostilled GMP evidence, the latest plant inspection report and the site master file, among other documents.
FAQ
FDA questions
What's the difference between the service fee and the FDA fee?
The service fee is ours, for consultancy and processing. The FDA fee is the government fee, which depends on your product.
Do I need a License to Operate before registering products?
Usually, yes. Food product registration, for example, requires the importer's LTO. See our LTO application service.
How long does it take?
From about 1 month for a food amendment to up to 36 months for a new prescription drug. Each timeline is listed in the tables above.
Do I need a registered company first?
Yes. The LTO needs your SEC or DTI registration. We can register your company first.
Speak to an FDA specialist.
Tell us your product and we'll confirm the requirements, fees and timeline.