On September 30, 2026, the Philippine Food and Drug Administration (FDA) released for public consultation the draft FDA Circular entitled “Modes of Regulatory Inspection for Food and Drug Administration Regulated Health Product Establishments”. Comments may be submitted by e-mail (pfpid@fda.gov.ph) by October 27, 2026. As the draft is highly relevant to cosmetics companies, CIRS Group has summarized its main contents for reference.
Background of the Draft
According to the draft, the Circular is issued pursuant to Republic Act (RA) No. 3720, as amended by Executive Order (EO) No. 175 and RA No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, which authorizes the FDA to conduct regulatory inspections of establishments and facilities involved in health products such as foods, drugs, and cosmetics.
It also implements the provisions on the regulatory inspection process under Section VIII.D of Administrative Order (AO) No. 2024-0015 (rules, requirements, and procedures for the application for License to Operate (LTO) of health product establishments), with the aim of establishing guidelines for the conduct of the identified modes of regulatory inspection and enhancing regulatory flexibility on a risk-based approach.
Scope
The draft applies to all regulated health product establishments, facilities, and vehicles engaged in activities involving health products, covering activities such as the manufacture, importation, sale, distribution, testing, and promotion of health products. Cosmetics establishments are within its scope.
Three Modes of Regulatory Inspection and Their Application
The draft establishes three modes of regulatory inspection — on-site inspection, remote inspection, and hybrid inspection — and the FDA will determine the applicable mode based on the results of a risk assessment of the establishment and the health products concerned.
Types of inspection are classified into pre-licensing inspection (for initial LTO applications or major variations), routine/post-licensing inspection (which may be conducted at any time during the validity of the LTO), and other types of inspection (investigation, monitoring, special assignments, etc.).
On-site Inspection:
As the default primary mode of inspection, it applies in principle to pre-licensing, routine, and other types of inspection. Inspections involving sample collection or conducted under legal orders, as well as those in cases of investigation or special assignments, must be conducted on-site. All initial LTO applications and major variation applications, as well as renewal applications that are not eligible for automatic renewal, shall in all cases be subject to on-site inspection.
Remote Inspection:
It applies to circumstances such as a declared national public health emergency or other state of emergency, declared travel restrictions and areas officially placed under restrictions that endanger the safety and welfare of inspectors. For non-manufacturing establishments located in Geographically Isolated and Disadvantaged Areas (GIDA) with internet access, pre-licensing inspections may be conducted remotely, provided that an on-site post-licensing inspection shall still be conducted afterwards.
In no case shall two consecutive remote inspections be allowed, and an on-site routine inspection shall still be conducted within one year in the absence of such restrictions. In addition, for establishments with a good compliance record (no compliance issues, and few or no field alert reports, recalls, or complaints), the FDA may apply remote inspection within the recommended inspection frequency for the corresponding risk level or within the validity period of the LTO.
Hybrid Inspection:
It refers to a mode combining on-site and remote inspection, with the specific arrangements to be discussed with the establishment to be inspected in advance. Common forms include: verifying documentary requirements or the implementation of corrective actions remotely after an on-site inspection; conducting a remote document review before an on-site inspection; and conducting on-site and remote inspection activities simultaneously.
According to Annex A of the draft, after receiving an inspection application, the FDA will determine the inspection mode based on the normal/emergency situation, the type of inspection, and the risk category of the establishment (high, medium, or low); where non-compliance is found, the establishment shall take corrective actions and, if necessary, undergo a re-inspection until compliance is achieved.
Key Impacts on Cosmetics Companies
(1) Cosmetics inspection rules will be updated in a unified manner: Cosmetics are health products regulated by the Philippine FDA, and companies engaged in cosmetic-related activities must obtain an LTO. The current FDA Circular No. 2013-002, Revised Guidelines in Licensing of Cosmetic Establishments, and its amendment will be amended upon the implementation of this Circular, and the inspection requirements for cosmetics establishments will be integrated into the new framework of inspection modes.
(2) Initial applications and major variations require on-site inspection: Cosmetics companies applying for an LTO to enter the Philippine market, as well as licensed companies undergoing major variations, will all be subject to on-site inspection. Companies should prepare in advance in terms of production premises and quality management systems.
(3) Companies with good compliance records may be eligible for remote inspection: Companies with no compliance issues and few or no records of recalls or complaints are expected to be eligible for remote inspection, which helps reduce inspection-related costs; however, two consecutive remote inspections are not allowed, and an on-site routine inspection shall still be completed within one year.
(4) Home-based operations fall within the scope of inspection: Where residential yards, garages, or similar premises are used to manufacture, process, pack, or store cosmetics, such areas will be regarded as establishments subject to regulatory inspection, which deserves attention from relevant small and micro business operators.
CIRS Reminder
The Philippines implements a management system for cosmetics that combines the License to Operate (LTO) for establishments with product notification. This draft Circular represents a significant update to the Philippines' LTO inspection system and will directly affect the licensing inspection arrangements for cosmetics companies.
CIRS reminds relevant cosmetics companies to closely follow the subsequent deliberation and official issuance of the draft; companies planning to enter the Philippine market should improve their premises and system conditions in accordance with the draft requirements before applying for an LTO; and companies already operating in the Philippines should continuously maintain a good compliance record and properly keep documentation related to production quality management for on-site or remote inspections.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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