FDA Consulting in the Philippines

Our FDA consultants can assist you with registering products across different categories such as cosmetics, drugs, supplements, food, toys, and more such as: CT, CPR, CPN, LTO, CMDR etc.
+63 (02) 8540-9623
info@tripleiconsulting.com
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What is the FDA, and what is its role in the Philippines?

The Food and Drug Administration (FDA) is the government agency that regulates the production of food, drug, cosmetic, medical, and all related products in the Philippines. Its primary function is to ensure the safety and quality of all products related to food, cosmetics, drugs, household products, and medical devices sold in the Philippine market. The FDA is also responsible for regulating the production and sale of the mentioned products to protect the health and safety of consumers in the Philippines. 

Types of FDA Applications in the Philippines:

License to Operate (LTO)

The following are the products that require a license to operate either as distributors, exporters, importers, manufacturers, or wholesalers:

  • Children’s Toys and Articles
  • Cosmetics
  • Drugs
  • Food
  • Heated Tobacco Products and Vapor Products
  • Household Urban and Hazardous Substances (HUHS)
  • Medical Devices

Requirements for getting an FDA license to operate:

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

Requirements for getting an FDA license for an Exporter to the Philippines:

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

Requirements for getting an FDA license for an Importer to the Philippines:

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

Requirements for getting an FDA license for a Wholesaler to the Philippines:

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

To know more about the requirements for verification and procedure for getting an FDA license to operate, read this article. 

Certificate of Product Registration (CPR)

  • A Certificate of Product Registration (CPR) is an authorization issued by the FDA after the approval of an application to register a health product
  • All FDA-licensed establishments are allowed to apply for a CPR except for establishments that are Distributor-Wholesalers only

Requirements for getting a Certificate of Product Registration (CPR) in the Philippines:

  • Accomplished application form through FDA Electronic Portal 
  • Clear and complete packaging label
  • Valid license to operate
  • Certificate of Analysis
  • Other documents (technical requirements)

Procedure for Certificate of Product Registration:

  1. Accomplish and submit application form through FDA Electronic Portal for pre-assessment
  2. If the application passes the pre-assessment, FDA will issue an Order of Payment
  3. Pay the corresponding fee. Once the FDA cashier posts payment, the next step in the application process is evaluation
  4. If the application is approved, an email notification from the FDA containing how/where to download the Certificate of Product Notification will be sent to your email address

Certificate of Product Notification (CPN)

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

Here are the procedures for processing certificate of product notification (CPN):

Medical Device Notification Procedure (this applies only for Low Risk, Class A medical devices):

  • Accomplish and submit application form for product notification through FDA Electronic Portal for pre-assessment
  • If the application passes the pre-assessment, FDA will issue an Order of Payment
  • Pay the corresponding registration fee. Once the FDA cashier posts payment, the next step in the application process is evaluation
  • If the application is approved, an email notification from the FDA containing how/where to download the Certificate of Product Notification will be sent to your email address

Cosmetic e-Notification, a.k.a. Cosmetic Product Notification Procedure:

  • Accomplish and submit the application form for product notification through FDA Electronic Portal
  • Pay the corresponding registration fee. Once the FDA cashier posts payment, the next step in the application process is evaluation
  • If the application is approved, an email notification from FDA containing how/where to download the Certificate of Product Notification will be sent to your email address
  • To know more about the procedure, download the FDA Memorandum Circulars and Cosmetic e-Notification Booklet for Applicants at the FDA site

Toys and Childcare Articles Notification Procedure:

  • Secure an LTO as an HUHS Manufacturer, Trader, and Distributor (Exporter/Importer/Wholesaler)
  • Fill out the Notification Template for Toys and Childcare Articles, including product information, description of the toy, source of the product, and all other pertinent information as to the name of the manufacturer, importer, and the local company responsible for placing the product in the market; and a declaration stating among others the full responsibility for the product, reports of adverse events and full cooperation on post-marketing activities

Product Batch Notification for Vapor Products and Heated Tobacco Products (HTPS) Procedure:

  • Accomplish application form through FDA Electronic Portal
  • Upload a copy of the safety data sheet (SDS) of the product
  • Documents must be in PDF file format
  • Once the application is submitted. An assessment slip will be electronically generated, which will serve as a reference for payment of the application 
  • Pay the corresponding fee. Once the FDA cashier posts payment, the next step in the application process is an evaluation
  • If the application is approved, an email notification from the FDA containing how/where to download the Certificate of Batch Notification will be sent to your email address

Certificate of Medical Device Registration (CMDR)

  1.  All medical devices manufactured in the Philippines or imported must undergo registration with the Philippines Food and Drug Administration’s Center for Device Regulation, Radiation, Health and Research (CDRRHR). 

Requirements for getting a Certificate of Medical Device Registration (CMDR) in the Philippines:

  • Establish a legal subsidiary entity to register the medical devices. It should be noted that any corporation with more than forty percent (40%) foreign equity should have a minimum capital of US$200,000
  • Assign a local distributor with an LTO in the Philippines to register the medical devices
  • Delegate registration of the medical devices to professional field experts such as Triple i Consulting Inc. The company is fully certified and has a License to Operate as a Distributor and Importer. It can act on behalf of foreign manufacturers or local distributors not equipped with an LTO to register the medical devices successfully. 

Clinical Trials (CT)

A crucial part of product registration is conducting clinical trials in the Philippines. 

The application process for Clinical Trials:

  1. Secure a License to Operate (LTO) as a sponsor or contract research organization (CRO)
    1. Apply through the Food and Drug Administration (FDA) E-portal with 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 such establishment)
      3. Credentials of Qualified Person [Good Clinical Practice (GCP) Certificates]
      4. Risk Management Plan 
      5. Proof of Payment
  2. Submit an initial clinical trial (CT) application with the following requirements:
  3. Cover Letter or Letter of Intent
  4. Accomplished CT application form
  5. LTO as Sponsor or CRO
  6. CT Dossier as per *FDA Circular No. 2012-007
    1. Part A: CT Protocol, Informed Consent Form, Case Report Form, Curriculum Vitae, and GCP Certificates of all Principal Investigators
    2. Part B: Good Manufacturing Practice (GMP) Certificate of Manufacturer, Certificate of Analysis, Stability Data, Manufacturing Data & Formulation, and Product Labelling of Investigational Products
    3. Part C: Investigator’s Brochure (Efficacy and Safety Data)
  7. Proof of payment
  8. After the initial evaluation, a clinical trial (CT) application may be assigned to a regulatory reviewer wherein sixty thousand pesos (Php 60,000.00) shall be charged to the applicant. 
  9. For imported investigational products and/or ancillary supplies, file an Import License (IL) application with the following requirements as per *FDA Circular No. 2012-007-A. The IL must be applied simultaneously with the initial CT application:
    1. Cover Letter or Letter of Intent
    2. Accomplished IL application form
    3. Proof of payment
  10. Conduct the clinical trial only when approval from the FDA and the Institutional Ethics Committee has been issued. 
    1. Other requirements to be accomplished by the applicant:
      1. Upload all required information to the Clinical Trial Registry within thirty (30) calendar days from receipt of the approval
      2. Submit all protocol amendments of the CT to the FDA for approval before implementation
      3. Report all Suspected Unexpected Serious Adverse Reactions (SUSARs) to the FDA following *ICH E2A guidelines. Fatal or life-threatening unexpected adverse reactions (AR) should be submitted to the FDA as soon as possible but not later than seven (7) calendar days after first knowledge by the sponsor. All other serious unexpected ARs should be filed as soon as possible but not later than fifteen (15) calendar days after first knowledge 
      4. Notify the FDA of any occurrence of protocol deviation
      5. Submit annual study progress reports to the FDA. 
      6. Inform the FDA of the termination of the clinical trial. If the study is complete, provide a copy of the results to the FDA.

Why it’s essential to register your products with the FDA Philippines

  1. Unregistered products found by the FDA will be removed from the market. A cease and desist order will be executed, and establishments with unregistered products will have to register their products and pay the penalty.
  2. Companies marketing or selling unregistered commodities being used for human consumption will have to face necessary sanctions as stated in the Republic Act 9711.
  3. Registration of products enables the corporation to reach potential clients.

How Triple i Consulting can help with your FDA Applications in the Philippines

  • Orientation to the proper processes and procedures in applying for company and obtaining the certificate of product registration (CPR).
  • Guidance in the preparation of all necessary documents to avoid rejection and minimize submission of incomplete documents.
  • Acquisition of approved applications by monitoring the step-by-step process necessary for ratification.
  • Other services, please inquire.

Triple i Consulting has a team of experts that can assist you through the process of acquiring a License to Operate (LTO), Certificate of Product Registration (CPR), Certificate of Product Notification (CPN), Certificate of Medical Device Registration (CMDR), and Clinical Trial (CT). As the first ISO 9001:2008 company in the Philippines to offer business registration services to its clients, Triple i Consulting is an expert consultant firm in the field of FDA applications.  

Need help with this? Instead of doing these tedious tasks yourself, you can Contact Us Here, fill out the form below, call us at +63 (02) 8540-9623, or email us at info@tripleiconsulting.com to book an initial consultation with one of our FDA experts.

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