FDA

The Food and Drug Administration (FDA) plays a critical role in the Philippines as the government agency responsible for regulating various products, including food, drugs, cosmetics, medical devices, and more. Its primary objective is to ensure the safety and quality of these products available in the Philippine market, ultimately safeguarding the health and well-being of consumers.

To obtain a License to Operate (LTO) from the FDA, certain products require this license for distribution, export, import, manufacturing, or wholesale purposes. The following products fall under this category:

1. Children’s Toys and Articles
2. Cosmetics
3. Drugs
4. Food
5. Heated Tobacco Products and Vapor Products
6. Household Urban and Hazardous Substances (HUHS)
7. Medical Devices

Requirements: To apply for an LTO, the applicant must fulfill the following requirements:

1. Business Permit
2. Certificate of Business Name Registration with DTI (for single proprietorships)
3. Certificate of Business Registration with SEC and Articles of Incorporation/Partnership (for corporations or partnerships)
4. Locational plan and Global Positioning System (GPS) coordinates
5. Proof of Income (Latest Audited Financial Statement with Balance Sheet)

The same requirements apply to exporters and importers, along with additional proof of income.

A Certificate of Product Registration (CPR) is a crucial authorization issued by the FDA upon approval of an application to register a health product. All FDA-licensed establishments, except Distributor-Wholesalers, can apply for a CPR.

Requirements for obtaining a Certificate of Product Registration (CPR): To apply for a CPR, the applicant must meet the following requirements:

1. Accomplished application form through FDA Electronic Portal
2. Clear and complete packaging label
3. Valid License to Operate
4. Certificate of Analysis
5. Other technical requirement documents

Procedure for obtaining a Certificate of Product Registration: The process for obtaining a CPR involves the following steps:

1. Accomplish and submit the application form through the FDA Electronic Portal for pre-assessment.
2. If the application passes the pre-assessment, the FDA will issue an Order of Payment.
3. Pay the corresponding fee. Once the FDA cashier confirms the payment, the application moves forward for evaluation.
4. If the application is approved, the FDA will send an email notification to the applicant, providing instructions on how and where to download the Certificate of Product Notification.

The FDA requires the Certificate of Product Notification (CPN) to enhance the application process and transparency of information for certain products, including Medical Device Notification, Cosmetic Product Notification, Toys and Childcare Articles Notification, and Product Batch Notification for Vapor Products and Heated Tobacco Products.

Procedures for obtaining a Certificate of Product Notification (CPN):

1. Medical Device Notification Procedure (applicable only for Low Risk, Class A medical devices):
   1. Accomplish and submit the application form for product notification through the FDA Electronic Portal for pre-assessment.
   2. If the application passes the pre-assessment, the FDA will issue an Order of Payment.
   3. Pay the corresponding registration fee. Once the payment is confirmed, the application moves forward for evaluation.
   4. If the application is approved, the FDA will send an email notification to the applicant, providing instructions on how and where to download the Certificate of Product Notification.
2. Cosmetic e-Notification (Cosmetic Product Notification) Procedure:
   1. Accomplish and submit the application form for product notification through the FDA Electronic Portal.
   2. Pay the corresponding registration fee. Once the payment is confirmed, the application moves forward for evaluation.
   3. If the application is approved, the FDA will send an email notification to the applicant, providing instructions on how and where to download the Certificate of Product Notification.
3. Toys and Childcare Articles Notification Procedure:
   1. Obtain an LTO as an HUHS Manufacturer, Trader, and Distributor (Exporter/Importer/Wholesaler).
   2. Fill out the Notification Template for Toys and Childcare Articles, providing product information, the toy’s description, the product’s source, and other relevant details, including the manufacturer and importer’s names and the local company responsible for placing the product in the market.
   3. Submit a declaration of full responsibility for the product, reports of adverse events, and commitment to post-marketing activities.
   4. Follow any additional requirements specified by the FDA.
4. Product Batch Notification for Vapor Products and Heated Tobacco Products (HTPS) Procedure:
   1. Accomplish the application form through the FDA Electronic Portal.
   2. Upload a copy of the safety data sheet (SDS) of the product in PDF format.
   3. Once the application is submitted, an assessment slip will be generated for payment.
   4. Pay the corresponding fee. Once the payment is confirmed, the application moves forward for evaluation.
   5. If the application is approved, the FDA will send an email notification to the applicant, providing instructions on how and where to download the Certificate of Batch Notification.

The Certificate of Medical Device Registration (CMDR) is required for all medical devices manufactured or imported in the Philippines. Registration is done through the Philippines Food and Drug Administration’s Center for Device Regulation, Radiation, Health and Research (CDRRHR).

Requirements for obtaining a Certificate of Medical Device Registration (CMDR): To obtain a CMDR, the applicant must fulfill the following requirements:

1. Establish a legal subsidiary entity for registering medical devices. If the corporation has more than 40% foreign equity, a minimum Philippine Peso equivalent capital of US$200,000 is necessary.
2. Assign a local distributor in the Philippines with an LTO to register the medical devices.
3. Consider delegating the registration process to professional field experts such as Triple i Consulting Inc., which has a License to Operate as a Distributor and Importer and can assist foreign manufacturers or local distributors without an LTO in successful registration.

A Certificate of Product Registration (CPR) is a crucial authorization issued by the FDA upon approval of an application to register a health product. All FDA-licensed establishments, except Distributor-Wholesalers, can apply for a CPR.

Requirements for obtaining a Certificate of Product Registration (CPR): To apply for a CPR, the applicant must meet the following requirements:

1. Accomplished application form through FDA Electronic Portal
2. Clear and complete packaging label
3. Valid License to Operate
4. Certificate of Analysis
5. Other technical requirement documents

Procedure for obtaining a Certificate of Product Registration: The process for obtaining a CPR involves the following steps:

1. Accomplish and submit the application form through the FDA Electronic Portal for pre-assessment.
2. If the application passes the pre-assessment, the FDA will issue an Order of Payment.
3. Pay the corresponding fee. Once the FDA cashier confirms the payment, the application moves forward for evaluation.
4. If the application is approved, the FDA will send an email notification to the applicant, providing instructions on how and where to download the Certificate of Product Notification.

The Certificate of Medical Device Registration (CMDR) is required for all medical devices manufactured or imported in the Philippines. Registration is done through the Philippines Food and Drug Administration’s Center for Device Regulation, Radiation, Health and Research (CDRRHR).

Requirements for obtaining a Certificate of Medical Device Registration (CMDR): To obtain a CMDR, the applicant must fulfill the following requirements:

1. Establish a legal subsidiary entity for registering medical devices. If the corporation has more than 40% foreign equity, a minimum Philippine Peso capital equivalence of US$200,000 is necessary.
2. Assign a local distributor in the Philippines with an LTO to register the medical devices.
3. Consider delegating the registration process to professional field experts such as Triple i Consulting Inc., which has a License to Operate as a Distributor and Importer and can assist foreign manufacturers or local distributors without an LTO in successful registration.

Conducting clinical trials is an essential part of product registration in the Philippines.

Application Process for Clinical Trials:

1. Secure a License to Operate (LTO) as a sponsor or contract research organization (CRO).
2. Apply through the FDA Electronic Portal, providing the following requirements:
   1. Accomplished application form
   2. Proof of Business Name Registration (Certificate of Business Registration/Certificate of Registration by Securities and Exchange Commission (SEC) and Articles of Incorporation/Law highlighting the provision creating the establishment)
   3. Credentials of Qualified Person (Good Clinical Practice (GCP) Certificates)
   4. Risk Management Plan
   5. Proof of Payment
3. Submit an initial clinical trial (CT) application, including a cover letter or letter of intent, accomplished CT application form, LTO as Sponsor or CRO, and a CT Dossier as per FDA Circular No. 2012-007.
4. For imported investigational products and/or ancillary supplies, file an Import License (IL) application simultaneously with the initial CT application.
5. Conduct the clinical trial only when approval from the FDA and the Institutional Ethics Committee has been obtained.
6. Fulfill additional requirements such as uploading information to the Clinical Trial Registry, submitting protocol amendments for FDA approval, reporting suspected unexpected serious adverse reactions (SUSARs) to the FDA, reporting protocol deviations, submitting annual study progress reports, and notifying the FDA of trial termination and providing study results.

Registering products with the FDA is essential due to the following reasons:

1. Compliance: Unregistered products found by the FDA will be removed from the market, and establishments with unregistered products will face a cease and desist order. Registering products ensure compliance with regulations and avoids penalties.
2. Consumer Safety: FDA registration ensures that products meet safety and quality standards, protecting the health and safety of consumers.
3. Legal Consequences: Companies marketing or selling unregistered products used for human consumption may face necessary sanctions as stated in Republic Act 9711.
4. Market Access: Product registration enables companies to reach potential clients and operate legally in the Philippine market.

Triple i Consulting offers expert assistance in various FDA applications in the Philippines. Their services include:

1. Orientation: Providing guidance on the proper processes and procedures for company registration and obtaining the Certificate of Product Registration (CPR).
2. Document Preparation: Assisting in the preparation of all necessary documents to avoid rejections and ensure complete submissions.
3. Application Monitoring: Tracking the step-by-step process of FDA application to ensure successful completion.
4. Additional Services: Triple i Consulting offers various other services related to FDA applications. For further details, interested parties can inquire directly.

Triple i Consulting is a leading consulting firm in the field of FDA applications in the Philippines. As the first ISO 9001:2008 company in the Philippines to offer business registration services, they have a team of experts ready to assist with acquiring licenses and registrations, including License to Operate (LTO), Certificate of Product Registration (CPR), Certificate of Product Notification (CPN), Certificate of Medical Device Registration (CMDR), and Clinical Trials (CT).

If you’d like assistance and support, reach out through one of the following channels to book an initial consultation with one of their FDA experts:

• Contact Us Here
• Fill Out the Form Below
• Call Us at +63 (02) 8540-9623
• Email us at: info@tripleiconsulting.com