The Philippine Food and Drug Administration (FDA)

The Philippine FDA was created through Republic Act No. 3720, series of 1963, as amended by Executive Order 175, series of 1987, otherwise known as the “Foods, Drugs, Devices and Cosmetics Act”, and has been strengthened by Republic Act No. 9711 otherwise known as “The Food and Drug Administration Act of 2009”.

With this mandate, the Philippine FDA has become one of the most stringent government agencies in the country, covering the registration of mostly anything you see in drugstores or hospitals. The general classifications of product registered in the FDA are the following:

1. Drugs (Prescription, OTC, Household Remedy)
2. Food/Food Supplements
3. Cosmetics
4. Household Hazardous Substances
5. Medical Device

With those 5 categories the FDA created the following Centers:

1. Center for Drug Regulation and Research (CDRR), FDA Alabang
2. Center for Food Regulation and Research  (CFRR), FDA Alabang
3. Center for Cosmetic Regulation and Research (CCRR), FDA Alabang - also responsible for Household Hazardous Substances
4. Center for Device Regulation, Radiation, Health and  Research (CDRRHR), DOH Manila

In liaising with this agency, a QPIRA (Qualified Person in Regulatory Affairs) is required. A QPIRA is generally a pharmacist, healthcare professional or an engineer (for medical devices) who has undergone specific training for specific Center by the FDA Academy. To further clarify, a QPIRA who has been trained under CDRR would need to undergo another training in case he needs to register cosmetic products. 

Among others, the FDA is also mandated to enforce the provisions of the following laws:

• RA 9502, or The Universally Accessible Cheaper and Quality Medicine Act of 2008, 
• RA 6675, or  The Generics Act Of 1988, 
• RA 5921, or The Pharmacy Law,
• RA 9211, or The Tobacco Regulation Act of 2003
• RA 7394, or The Consumer Act of the Philippines
• RA 7581/10623, or The Price Act
• RA 10611, or The Food Safety Act of 2013
• RA  8172, or The ASIN Law,
• RA 8203, or The Special Law on Counterfeit Drug
• RA 8976, or The Food Fortification Law
• RA 9165, or The Comprehensive Dangerous Drugs Act
• RA 9257, or The Expanded Senior Citizens Act of 2003
• PD No. 881, or The Household Hazardous Act
• EO No. 51, or The Milk Code of the Philippines
• RA 10354, or The Responsible Parenthood and Reproductive Health Bill of 2012
• PD 856, or The Code of Sanitation of the Philippines

Due to other laws in the country, visiting the FDA main office is now prohibited unless an approved appointment with the FDA personnel has been set. The public and QPIRA must go directly to FDAC (FDA Center) in Starmall, Alabang when forwarding letters, submitting applications, inquiring, and even following-up pending applications. Except for Center for Cosmetics all the other Centers have frontliners willing to accommodate the industry's concern from 8:00 am - 5:00 pm, Monday - Friday,  except holidays. For immediate inquiries, the FDAC contact numbers are also available. See list below: 

• 02-821-1162
• 02-821-1176
• 02-821-1177
• 02-821-1220
• 02-821-1159
• 02-877-0259 (FDA Academy)

Should you want to be updated on current news on FDA, you may check visit www.fda.gov.ph.