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Liz Servañez
Liz Servañez serves as Branch Manager in the Philippines.
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Christine Aguilar
Christine Aguilar serves as Head of Operations in the Philippines.
Did you know that most consumer products imported, manufactured, or sold in the Philippines require individual assessment and registration by the country’s Food and Drug Administration (FDA)? The FDA’s Certificate of Product Registration (CPR) confirms that goods meet essential safety and quality standards before they reach the market.
If you plan to expand your business into the Philippines within a regulated industry, you must ensure compliance with FDA regulations through proper certifications and registrations. This guide will explain the process of applying for FDA certificates in the Philippines.
FDA registration overview in the Philippines
Understanding the FDA’s role in business operations in the Philippines
The Food and Drug Administration reports to the Department of Health in the Philippines and monitors regulations for any business activities that involve manufacturing, trading, and distributing (wholesale, import, or export) within FDA-regulated industries:
- Food and beverage
- Cosmetics
- Drugs and pharmaceuticals
- Medical Devices and In-Vitro diagnostic devices / Reagents
- Household/Urban Hazardous Substances (HUHS) and pesticides
- Toys and childcare articles
Crucially, before your company can register any products, you must first obtain a License to Operate (LTO) from the FDA. The LTO is the legal permission for your company to conduct its activities in the regulated industries in the Philippines before you can apply for FDA registration for your products.
Types of FDA certificates in the Philippines
Once a product has been assessed by the FDA and approved for the Philippine market, they will issue a certificate, often referred to as FDA clearance. This certificate is essential for company operations as it ensures that any goods being produced or sold meet necessary standards. The designation of the certificate varies depending on the type of product being assessed:
- Certificate of Product Registration (CPR): The most common type of certificate, applies to food, drug and HUHS products
- Certificate of Product Notification (CPN): Applies to cosmetic products
- Certificate of Medical Device Registration (CMDR): Applies to medical devices and related products
Processing fees for each certificate vary and are determined case-by-case, including FDA/government fees and legal research fees. Cosmetics may incur additional fees depending on product variants.
Remember, failing to secure the correct product certificate can lead to fines and potentially business closure.
Securing an FDA Certificate of Product Registration (CPR)
How to Apply for the FDA CPR
After your company has obtained its License to Operate (LTO) in the Philippines, you can apply for an FDA certificate for your specific regulated products. These certificates are typically valid for 2 to 5 years and must be renewed before they expire.
To apply for an FDA certificate of Product Registration (CPR), you will need to prepare and submit the following:
- Application form: must be accompanied by a valid LTO issued by the FDA in the Philippines
- Product labels: Provide copies of labels for all packaging sizes, including clear photos of the product in its packaging from various angles. You’ll also need supporting documents for any logos, seals, or certifications (e.g., Halal, Sangkap Pinoy) mentioned on the label.
- Product documents: Include documentation that supports any product claims, such as details on physiochemical and microbiological characteristics. Specifications must align with ASEAN directive regulations.
- Certificate of analysis: Details on the product, must be relevant to food standards and regulations compliance.
- Product Sample: You must provide a physical, representative sample of your product, exactly as it will appear commercially, complete with all labels.
It’s important to note that any changes made to the product after certification can invalidate the FDA certificate. If your product changes, you will need to apply for a renewal reflecting these amendments.
Emerhub’s regulatory advisors have been helping companies secure FDA registration in the Philippines for over a decade. We can help you prepare the necessary documents and manage the application and renewal process for you.
Renewing Your CPR: Choosing the Right Method
As mentioned, a CPR in the Philippines usually expires after two to five years. You must request renewal at least one month before the expiration date through FDA offices. There are two renewal paths for FDA certificates:
| Type of renewal | Product Status | Key Requirements |
|---|---|---|
| Automatic Renewal | No changes made to the product | – Application form – Proof of payment of fees – Acknowledgment letter from FDA (only if conditions included in CPR) |
| Product Status | Changes have been made to the product | – Application form – Proof of payment of fees – Supporting documentation for any amendments to the product – Product labels (same requirements as initial application) |
Some products are more likely to go through amendments and changes, especially with food safety regulations being in constant evolution. Emerhub’s experts can help you determine which FDA certificate renewal method is appropriate for your product(s) and manage the renewal process on your behalf.
Secure Your FDA Registration Certificates with Expert Help
Selling a product without the proper FDA registration in the Philippines can result in the FDA issuing a fine and seizing/terminating the product from the market. The Administration will also issue a public warning against your product.
Products that have been removed by the FDA can be reintegrated after paying the fine and obtaining the right certificate. However, it can be very difficult for a company to recover from the negative consumer response that can result following an FDA public warning. It is therefore advisable to consult local experts such as Emerhub and properly register your products.
Emerhub understands the complexities of FDA requirements and can help guide you throughout the entire registration process to avoid any compliance risks.
If you are looking to operate your business in an FDA-regulated industry in the Philippines, get in touch with one of our advisors via the form below!
Frequently asked questions
FDA registration is the process of acquiring necessary licenses and certificates from the Philippine Food and Drug Administration (FDA). This is mandatory to legally operate a business that manufactures, imports, exports, distributes, or sells FDA-regulated products within the country.
To legally import, distribute, or sell regulated products, your company must first obtain a License to Operate (LTO) from the Philippine FDA. This license allows your business to operate in specific regulated industries. Once you have an LTO, your individual products then require specific authorizations, such as a Certificate of Product Registration (CPR) for food, drugs, and household/urban hazardous substances (HUHS); a Certificate of Product Notification (CPN) for cosmetics; or a Certificate of Medical Device Registration (CMDR)/Notification (CMDN) for medical devices.
Yes, any company involved in the manufacturing, import, export, distribution, or sale of FDA-regulated products requires an LTO.
To apply for product certificates like a CPR, the applicant must be a company that holds a valid License to Operate (LTO) issued by the FDA in the Philippines. This generally means that a foreign company would need to establish a local subsidiary in the Philippines or partner with a licensed local importer/distributor who holds an LTO.
The FDA processing time can vary based on the product type and the completeness of the application. It typically ranges from a 3-6 months for low risk products and 6-12 months or longer for high risk products.
LTO requirements include business permits, site master file (for manufacturers), risk management plan, proof of payment, and more. You can read our article on FDA LTO for more details.
