Philippines FDA Proposes New Requirements for LTO Application

On February 27, 2024, Philippines Food and Drug Administration (FDA) initiated a consultation on a new draft of Prescribing the Rules, Requirements and Procedures in the Application for License to Operate of Covered Health Product Establishments with the Food and Drug Administration Repealing for the Purpose Administrative Order No. 2020-0017. Any comments can be sent to [email protected] no later than March 12, 2024.¹

In Philippines, companies that manufacture, import, distribute, or sell cosmetic products are required to obtain a License to Operate (LTO) from the FDA. In 2020, Administrative Order (AO) No. 2020-0017 was issued, outlining the necessary documents and procedures for LTO applications. To further streamline the processes for initial, renewal, and variation applications for LTO, the FDA introduced amendments to AO No. 2020-0017 in 2022 and 2023, respectively. Compared to these two prior draft amendments, the current 2024 version primarily includes two key changes, including:

1. Updating the requirements and validities for initial, renewal and variation applications

The new draft establishes a new classification under the renewal application, the automatic renewal. Following the pre-licensing inspection, a recommendation letter, which serves as the basis for automatic renewal, will be issued upon the determination of compliance with FDA requirements. The draft also updates the requirements and validities for LTO applications, as presented in the table below.

Application Types	Validity		Requirements
Application Types	Micro and Small Enterprises	Medium and Large Enterprises	Requirements
Initial	3 years	6 years	1. Accomplished eApplication form with Declaration and Undertaking; 2. Proof of business name registration, and FDA-regulated activity; 3. For micro small medium enterprises (MSMEs): certification from the Department of Trade and Industry as proof of their level of categorization; 4. Risk Management Plan; 5. For manufacturers (including packers / re-packers / re-furbishers): Site Master File (SMF); 6. For manufacturers (including packers / re-packers / re-furbishers), traders, distributors (importers, exporters, wholesalers): list of sources and authorized suppliers/clients; 7. Payment of appropriate fees.
Renewal	6 years	12 years	Automatic Renewal (subject to exceptions provided in Annex E of this draft): 1. Accomplished eApplication form; 2. The application is filed before the expiration date of the license; 3. The prescribed renewal fee is paid upon filing of the application; 4. A sworn statement (Declaration and Undertaking) indicating no change or variation whatsoever in the establishment is attached to the application. Regular Renewal 1. Accomplished eApplication form with Declaration and Undertaking; 2. For manufacturers (including packers / re-packers / re-furbishers): a copy of valid GMP Certificate; 3. For MSMEs: updated certification from the Department of Trade and Industry as to level of classification; 4. Payment of appropriate fees.
Variation	Same as the validity period of the existing LTO		1. Accomplished eApplication form with Declaration and Undertaking; 2. Documentary requirements depending on the variation applied for; 3. Payment of appropriate fees.

2. Clarifying FDA's decision grounds for LTO applications

A decision on the LTO application consists of approval, disapproval, and suspension or cancellation/revocation. Alongside the current provisions on disapproval and cancellation, the draft newly presents the grounds for approval and adds details on the suspension, cancellation, or revocation of issued LTOs, to promote transparency, as shown below.

Decision on Applications	Grounds for FDA's Decisions
Approval	1. Upon evaluation, the submitted application is deemed compliant; 2. During inspection, the company demonstrates full adherence to technical standards.
Suspension, or Cancellation/Revocation	1. The applicant has willfully violated FDA-implemented regulations, or failed to file a renewal application 120 days after the previously issued LTO expired; 2. The application requirements submitted demonstrate that the company does not meet the required technical requirements or appropriate standards; 3. The applicant has made misrepresentations or false entries, and/or has withheld any relevant data contrary to the provisions of FDA-implemented regulations; 4. The owner has violated any of the terms and conditions of its license; 5. FDA determines that there are other similar grounds for suspension, or cancellation/revocation.

In addition to the two major changes mentioned above, the draft updates the glossary of term definitions, provides supplementary annexes on payment procedures and charging rules, and reorganizes the existing provisions to enhance the clarity and logic of this guidance. Details of these amendments can be found here.