G/TBT/N/PHL/361

31 March 2026

(26-2550)

Committee on Technical Barriers to Trade

Original: English

2.

Agency responsible:

Atty. Paolo S. Teston

Director General

Food and Drug Administration

DEPARTMENT OF HEALTH

3.

Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], Other:

4.

Products covered (HS codes or national tariff lines. ICS numbers may be provided in addition, where applicable): Pharmaceutics (ICS code(s): 11.120)

5.

Details of notified document(s) (title, number of pages and languages, means of access): Use of Official Digital Regulatory Platforms for Issuance of Marketing Authorization for Pharmaceutical Products for Human Use; (3 page(s), in English)

Link to notified document(s) and/or contact details for agency or authority which can provide copies upon request:

https://members.wto.org/crnattachments/2026/TBT/PHL/26_01781_00_e.pdf

https://members.wto.org/crnattachments/2026/TBT/PHL/26_01781_02_e.pdf

https://members.wto.org/crnattachments/2026/TBT/PHL/26_01781_03_e.pdf

https://members.wto.org/crnattachments/2026/TBT/PHL/26_01781_01_e.pdf

https://www.fda.gov.ph/draft-for-comments-use-of-official-digital-regulatory-platforms-for-issuance-of-marketing-authorization-for-pharmaceutical-products-for-human-use/

Dr. Charmaine Ann M. Rabago

Officer-in-Charge, Director IV

Center for Drug Regulation and Research

Food and Drug Administration

DEPARTMENT OF HEALTH

Email: cdrr.od@fda.gov.ph, cdrr.sds@fda.gov.ph

6.

Description of content: The policy institutionalizes the use of FDA eServices and other official digital regulatory platforms in the submission, evaluation, and issuance of marketing authorization of pharmaceutical products for human use.

7.

Objective and rationale, including the nature of urgent problems where applicable: Republic Act (RA) No. 3720, otherwise known as the "Foods, Drugs and Devices, and Cosmetics Act", as amended, and RA No. 9711, otherwise known as the "Food and Drug Administration (FDA) Act of 2009", and its implementing rules and regulations, mandated the FDA to ensure the safety, efficacy, and quality of health products in the Philippines. The FDA continuously adopts regulatory innovations to enhance efficiency, transparency, traceability, and integrity of regulatory processes.

Consistent with the principles of Good Review Practices (GRevP) promoted by the World Health Organization, regulatory authorities are encouraged to institutionalize structured, transparent, consistent, and well-documented review processes supported by digital systems. Advancing digital regulatory maturity is critical to improving review timelines, enhancing traceability of regulatory actions, ensuring data integrity, and promoting reliance and regulatory convergence.

In support thereof, official digital regulatory platforms such as FDA eServices Portal System were developed to be the online platform for FDA Authorization applications. The Automatic Renewal (AR), Principal Certificate of Product Registration (PCPR) conversion, and Certificate of Listing of Identical Drug Product (CLIDP) applications through the eServices Portal System have been implemented in 2021.

The increasing volume and complexity of applications for marketing authorization necessitates the streamlined use of electronic systems to support regulatory submissions, evaluation, communication, and issuance of authorizations. Therefore, the Circular is being issued to institutionalize FDA eServices and other official digital regulatory platforms to support good regulatory practices, business continuity, and improved stakeholder access to FDA services.

8.

Relevant documents:

• Republic Act (RA) 3720: "Foods, Drugs and Devices, and Cosmetics Act"

• RA No. 9711: "Food and Drug Administration (FDA) Act of 2009"

• FC No. 2020-026: Food and Drug Action Center (FDAC) New Normal Operational Guidelines of the Food and Drug Administration

• FDA Advisory (FA) No. 2022-0418: Implementation of the Food and Drug Administration eServices Portal System for Certificate of Listing of Identical Drug Product (CLIDP) Applications

9.

Proposed date of adoption: To be determined

Proposed date of entry into force: To be determined

10.

Provision of comments

Final date for comments: 10 April 2026

[ ] 60 days from notification

Contact details of agency or authority designated to handle comments regarding the notification:

Mr. Neil P. Catajay

Director

Bureau of Philippine Standards

Department of Trade and Industry

3F Trade and Industry Building

361 Sen. Gil Puyat Avenue

Makati City

Philippines

1200

Tel: (632) 751 4700; (632) 7913128

Email: bps@dti.gov.ph

Website: http://www.bps.dti.gov.ph