The Food and Drug Administration (FDA) Philippines is the agency that ensures the health and safety of food and drugs consumed by the Filipino public. FDA Philippines is tasked to license, monitor, and regulate food, drugs, cosmetics, medical devices, and hazardous waste in the country.

FDA Philippines is needed by drug establishments, food establishments, medical device establishments, and cosmetic establishments, whether they manufacture, distribute, and import products, as long as they enter the Philippine market.

FDA Philippines headquarter is along Civic Drive, Filinvest Corporate City, Alabang. In Metro Manila, its satellite office is in Ali Mall, Cubao, Quezon City.

The following are some information needed by the public who wishes to contact or transact with FDA Philippines.

A. FDA Philippines website: www.fda.gov.ph

B. Procedure on how to request for an ePortal Account from FDA Philippines (FDA Circular 2016 – 004):

1. Read FDA Circular 2016 – 004 for format of email and the authorization letter (bottom of the file).

Subject: Request for eLTO User Account

Body:

1. E-mail address: (preferably company e-mail address)
2. Name of authorized representative (preferably permanently employed)
3. Position in the company:
4. Contact Number:
5. Company Name:
6. Attach notarized authorization letter (Annex B of FDA Circular 2016 – 004).
7. Send request to fdac@fda.gov.ph.
8. Wait for the email response of FDAC for the username and password of your ePortal account.

Processing of ePortal account may last from five to seven days.

C. Guidelines on how to secure a License to Operate (LTO) from FDA Philippines:

1. Go to the link: eportal.fda.gov.ph.
2. Log in using the username and password in B.
3. Click “New Case”
4. Double click License to Operate v2.0.
5. Fill up the form.
6. Attach the documentary requirements (must be in pdf files; maximum of 2MB/file). To upload additional documents, an “Attach” option can be found at the top of the Title bar.
7. Download and print the order payment.
8. Finish and submit the application. To guarantee that the application was filed and submitted, kindly check the “Continue” after generating the Order of Payment.
9. Pay through FDA Cashier or Land Bank branches.

D. List of Requirements to needed to get a License to Operate (LTO) from FDA Philippines (AO 2016 – 0003):

1. Proof of Business Name (DTI or SEC & Articles of Incorporation

2. Business Permit (Mayor’s Permit/Barangay Clearance)

3. Qualified Person and the relevant credentials

Type of Establishment	Qualified Person	Credentials
Drug Establishment	Pharmacist	PRC ID; Attendance to FDA appropriate licensing seminar
Food Establishment	Regulatory Officer	Licensing Seminar, GMP, HACCP, or Food Safety Seminar
Medical Device Establishment	Pharmacist or Any Other Qualified Professional	PRC ID; Attendance to medical device QPIRA
Cosmetic Establishment	Pharmacist or Any Other Qualified Professional	PRC ID; Attendance to QPIRA

If no attendance to FDA Seminar yet, attach a promissory letter stating your commitment to attend and proof of enrollment.

1. Site Master File (for manufacturers of drugs, devices, and cosmetics)
2. Risk Management Plan (for manufacturers and distributors of drugs and medical devices establishments, drugstores, and RONPDs)

E. FDA Philippines Training Application Process:

1. Visit www.fda.gov.ph.

2. Click Industry Corner then Downloadables then search for FDA Academy Forms.

3a. Download the Course Registration Form. Save on your desktop before filling-up necessary information needed.

3b. Download Authorization Letter (if needed) and have it signed by the manager or the owner.

4. Upon completion of filling-up the form, save it and send the application form together with other requirements to enroll.fdaacademy@gmail.com. Do not forget to attach scanned copy of 2 x 2 picture with nametag.

5. Wait for the FDA Academy reply.

5a. RESUBMIT (if you have deficiencies)

5b.1. ASSESSMENT SLIP (one slot allotted for you) to be paid within five (5) days upon issue. Failure to settle the account within the specified time will automatically cancel your application.

5b.2. CONFIRMATION SLIP will be issued upon furnishing FDA with proof of payment (official bank receipt, bank validated assessment slip, or bank validated deposit slip).

If there is no available schedule,

ACKNOWLEDGMENT (as waitlist) will be sent, if you have submitted correct and complete requirements, subject to further assessment upon availability of the seminar schedule. 

The ACKNOWLEDGMENT may be used in lieu of the Seminar Certificate (required for registration or renewal) until such time you have attended the required seminar.

If after a week, you have not yet received a reply, you may contact FDA for verification purposes at 877 – 0259.

F. FDA Philippines Guidelines to Secure a Certificate of Product Registration (CPR)

FDA Circular 2016 – 014 – Procedure for the use of electronic registration (E-Registration) system for prepackaged processed food products

G. FDA Philippines Guidelines on Labeling of Prepackaged Food Products

Administrative Order 2014 – 0030 – Revised rules and regulations governing the labeling of prepackaged food products further amending certain provisions of A) 88-B s. 1984 or the “Rules and Regulations Governing the Labeling of Pre-packaged Food Products Distributed in the Philippines,” and for other purposes

For more information, please visit www.fda.gov.ph.

FDA Philippines Contact Numbers: (02) 821 – 1176, (02) 821 – 1177, (02) 821 – 1159, (02) 821 – 1162, and (02) 821 – 1220

FDA Cubao Satellite Office Contact Number: (02) 294 – 8017