Exhibiting at IFEX Philippines 2025

The Food and Drug Administration (FDA) of the Philippines is a regulatory authority under the Department of Health (DOH), responsible for ensuring the safety, efficacy, and quality of food, drugs, cosmetics, medical devices, household hazardous substances, and other health-related products. As a cornerstone of public health governance, the FDA plays a crucial role in protecting and promoting the right to health of the Filipino people.

Brief History

The origins of FDA Philippines date back to the creation of the Food and Drug Administration in 1963 under Republic Act No. 3720. Initially established as the Food and Drug Administration (FDA), the agency evolved from the Bureau of Food and Drugs (BFAD), which was restructured back into FDA in 2009 via Republic Act No. 9711, the FDA Act of 2009. This legislation expanded the agency's authority and modernized its systems, allowing it to become more efficient and technologically capable in fulfilling its regulatory functions.

Core Business

FDA Philippines is the national regulatory agency mandated to oversee the manufacture, importation, distribution, sale, and marketing of health products. It ensures consumer protection and public health through effective regulation and consistent monitoring of products circulating in the market.

Its responsibilities include:

• Issuing Licenses to Operate (LTO) to establishments
• Granting Certificates of Product Registration (CPR) for health-related products
• Conducting pre- and post-market surveillance
• Implementing product recalls and issuing public advisories
• Running training programs and technical seminars through the FDA Academy

Product and Service Offerings

The services offered by the FDA are regulatory in nature and include:

• Licensing and Accreditation:

  • License to Operate (LTO) for drugstores, manufacturers, importers, distributors
  • Authorization of Food, Cosmetics, Medical Devices, and Health Supplements

• Product Evaluation and Registration:

  • Certificates of Product Registration (CPR)
  • Notifications for low-risk products (e.g., cosmetics)

• Laboratory Testing:

  • Product sampling and analysis through DOH-recognized labs

• Training and Education:

  • FDA Academy training modules for Micro, Small, and Medium Enterprises (MSMEs)
  • Regulatory education for compliance officers and business stakeholders

• Public Health Advocacy:

  • Health advisories and recalls
  • Campaigns for safe medicine and food consumption

Specialization and Core USP

The FDA specializes in the regulation of all health products sold and distributed in the Philippines, providing oversight from production to post-market surveillance. Its core unique value proposition is its authority to enforce health standards through science-based policy, risk assessment, and law enforcement mechanisms.

The FDA has digitalized its services through the eServices Portal, enabling online applications for LTOs and CPRs, significantly reducing transaction time and increasing transparency.

Financial Strength

As a government agency, FDA Philippines is primarily funded by:

• The General Appropriations Act (GAA)
• Regulatory fees collected from licensees and registrants

In 2023, the FDA collected approximately PHP 2.5 billion in regulatory fees, reflecting increased compliance and improved digital processing systems. The agency reinvests in infrastructure, lab capabilities, and human resource development to enhance public service.

Shipment Data

While not a product exporter or importer, the FDA plays a vital role in regulating shipments by:

• Monitoring the importation of regulated health products
• Requiring importers to secure Clearance for Customs Release (CFCR)
• Coordinating with the Bureau of Customs (BOC) to detain or recall unregistered or substandard products

In 2023, the FDA reviewed over 18,000 import permits and issued more than 60 public health alerts regarding unauthorized shipments.

Target Market

The FDA’s services impact various stakeholders:

• Health Product Manufacturers: Pharmaceutical, food, and cosmetic companies
• Importers and Exporters: Ensuring compliance with regulatory requirements
• Retailers and Distributors: Drugstores, supermarkets, and online vendors
• Healthcare Institutions: Hospitals, clinics, diagnostic centers
• Consumers: Receiving education and protection from substandard products

Capabilities

The FDA operates through a centralized and regional network:

• Main office in Alabang, Muntinlupa City
• Four Centers for Product Regulation: Food, Drugs, Cosmetics, Devices
• Laboratories equipped for chemical and microbiological analysis
• Digital Systems: ePortal, eNotification, eLTO, eCPR

It collaborates with international organizations such as the World Health Organization (WHO) and ASEAN regulatory bodies to align with global standards.

Certifications and Compliance Records

The FDA adheres to multiple national and international regulatory benchmarks:

• WHO-recognized Good Regulatory Practice (GRP)
• ISO 9001:2015 Certification for Quality Management Systems
• Philippine Civil Service Commission accreditation for good governance

It is also a member of:

• ASEAN Consultative Committee for Standards and Quality (ACCSQ)
• ASEAN Medical Device Committee (AMDC)
• International Medical Device Regulators Forum (IMDRF)

Customer Testimonials

Public satisfaction surveys conducted by the Civil Service Commission report a customer satisfaction rate of over 85%. Users of the eServices Portal have noted significant improvements in speed and user interface. Businesses have particularly appreciated the FDA Academy for clarifying regulatory requirements.

Major Achievements

• Fully digitalized LTO and CPR application processes
• Reduced turnaround time for licensing from 90 days to 14 working days
• Launched a centralized FDA ePortal System for seamless regulatory transactions
• Strengthened post-market surveillance and enforcement through Risk-Based Inspection Model
• Recognized by DOH as one of its top-performing agencies in 2022–2023

The Food and Drug Administration of the Philippines continues to strengthen its mandate by embracing digital innovation, stakeholder education, and global best practices to safeguard public health and consumer welfare in an increasingly complex health products landscape.