The Food and Drug Administration (FDA) Overview

Summary

The Food and Drug Administration (FDA) is a key regulatory agency that ensures the safety, quality, and efficacy of health products in the Philippines. Established in 1963, its role includes overseeing food, drugs, cosmetics, medical devices, and household products. Over the years, the agency has evolved with various legislative changes, strengthening its capacity to protect public health. The FDA's core functions involve product registration, market surveillance, enforcement, and licensing of establishments. Its mission is to safeguard public health by ensuring that all health products meet required standards of safety and quality.

Takeaways

• 😀 The FDA (Food and Drug Administration) was established on June 22, 1963, with the passage of Republic Act No. 3720, known as the Food, Drug, and Cosmetic Act.
• 😀 The FDA's mandate is to ensure the safety and quality of food, drugs, cosmetics, and to regulate their production, sale, and distribution to protect public health.
• 😀 The FDA was renamed the Bureau of Food and Drugs (BFAD) in 1982, before being reverted back to FDA in 2009 with the signing of Republic Act 9711.
• 😀 The FDA's mission is to guarantee the safety, quality, purity, and efficacy of health products to protect and promote the right to health for the public.
• 😀 The FDA is divided into different centers responsible for regulating specific products, including cosmetics, drugs, medical devices, food, and more.
• 😀 The CCHSRR (Cosmetics, Household, and Hazardous Substances Regulation) oversees cosmetics, household pesticides, toys, and children's health products.
• 😀 The CDRR (Center for Drug Regulation and Research) regulates drugs, vaccines, biologicals, herbal medicines, and veterinary products.
• 😀 The CDRHR (Center for Device Regulation, Radiation Health, and Research) handles medical devices, radiation-emitting devices, and in-vitro diagnostics.
• 😀 The CFDR (Center for Food and Drug Regulation) focuses on regulating prepackaged food, food supplements, food additives, and raw materials for food.
• 😀 Key FDA functions include licensing health product establishments, product registration, post-marketing surveillance, and enforcing compliance with health product regulations.

Q & A

What is the primary role of the FDA?

The primary role of the FDA is to ensure the safety, efficacy, purity, and quality of health products such as food, drugs, cosmetics, medical devices, and other related products.

When was the FDA established and under what law?

The FDA was established on June 22, 1963, with the passage of Republic Act No. 3720, also known as the Food, Drug, and Cosmetic Act.

What significant change happened to the FDA on December 2, 1982?

On December 2, 1982, the agency's name was changed to the Bureau of Food and Drugs (BFAD) through the signing of Executive Order 851.

What was the impact of Executive Order 175 signed on May 22, 1987?

Executive Order 175 amended RA 3720 and expanded the FDA's scope to include medical devices, alongside its original focus on food, drugs, and cosmetics.

How did Republic Act 9711, signed on August 18, 2009, affect the FDA?

Republic Act 9711 renamed the Bureau of Food and Drugs back to the FDA and further strengthened its regulatory capacity by establishing testing laboratories, upgrading equipment, increasing manpower, and allowing the retention of income.

What is the FDA’s vision for the year 2026?

The FDA's vision is to become an internationally recognized center of excellence in health product regulation by 2026.

What is the mission of the FDA?

The FDA’s mission is to guarantee the safety, quality, purity, and efficacy of health products in order to protect and promote the right to health of the general public.

What products are regulated by the FDA’s Center for Cosmetics and Household Products (CCHSRR)?

The CCHSRR regulates cosmetic products, household urban hazardous substances, household pesticides, toys, and childcare articles for children below 14 years old.

What does the FDA’s Center for Drug Regulation and Research (CDRR) oversee?

The CDRR oversees drug products, vaccines, biologicals, traditional and herbal medicines, home remedies, medical oxygen, and veterinary products.

What are the core functions of the FDA as a regulatory agency?

The core functions of the FDA include licensing health product establishments, registering products, conducting post-marketing surveillance, and enforcing regulations through actions like search warrants, product seizures, and establishment closures.