Compared to the Circular No. 2018-001 currently in force, the Updated Guidelines adopts proper classification to present the previously included guidelines in a more clear and logical manner, and provides important supplements to PIF Audit.

Editor's Note: This article was originally published on Jul. 29, 2022, and was updated on Feb. 1, 2023, as per the latest developments.

On July 21, 2022, Philippines Food and Drug Administration (FDA) commenced a public consultation on a preliminary draft of Updated Guidelines on Product Information File (PIF) for Cosmetic Products Repealing FDA Circular No. 2018-001 "Reiterating the Mandatory Implementation of Article 8 of the ASEAN Cosmetic Directive, Product Information" (the Updated Guidelines). On January 19, 2023, Philippines FDA released the finalized version, which will take effect 15 days after its publication in a nationwide circulated newspaper, and filing with the University of the Philippines, Office of the National Administrative Register.¹

Introduction to PIF

The Product Information File (PIF) is a document storing the evidence for reviewing the safety, quality and claimed efficacies of cosmetic products. Pursuant to the ASEAN Cosmetic Directive (ACD), the cosmetics Market Authorization Holder (MAH) in Philippines shoulders the responsibility to create and maintain a PIF on a per-product basis. Consistent with the ASEAN Guidelines for Product Information File, the documents that MAHs need to keep in PIF shall be organized as follows:

• Part I: Administrative Documents and Product Summary
• Part II: Quality Data of Raw Material
• Part III: Quality Data of Finished Product
• Part IV: Safety and Efficacy Data

Important Changes Introduced in the Updated Guidelines

On January 24, 2018, Philippines FDA issued Circular No. 2018-001 to guide MAHs in the maintenance of PIF. As the successor to this circular, the Updated Guidelines retains the previous supervision framework, and adopts proper classification to present the guidelines in a more clear and logical manner. Moreover, the Updated Guidelines provides necessary supplements to the previous guidelines contained in Circular No. 2018-001, especially to the guidelines for PIF Audit.

Regarding PIF Audit, Circular No. 2018-001 briefly introduced the types of audit and the timeline for MAHs to comply with the documentary requirements. In comparison, the Updated Guidelines rolls out a detailed plan for PIF Audit with important supplements, including:

1. Outlining Situations When FDA May Conduct Ad hoc PIF Audits

The FDA conducts both routine and Ad hoc PIF Audits to perform its post-marketing surveillance duty. For routine audit, a Notice of Audit (NOA) shall be sent to the MAH one month ahead, while the Ad hoc audit may be organized without notice in advance. In general, any of the following events may trigger an Ad hoc PIF Audit:

• results from sampling, testing, and verifying products from the market;
• consumer complaints;
• adverse event reports from healthcare practitioners and other verifiable sources;
• evaluation of ingredients, formulation, intended use; and/or product claims during notification application;
• post-licensing inspections, monitoring, and investigations;
• advertisements and promotional articles monitoring;
• post-marketing surveillance (PMS) activities;
• coordination with local enforcement agencies, government agencies, and international partners; and,
• other assessments, reviews, and/or investigations initiated; or referred to the FDA which finds that a cosmetic product has issues relating to safety, quality, and/or claimed benefits which necessitate FDA intervention.

2. Proposing Off-site PIF Audit as A Feasible Audit Option

The Covid-19 pandemic related mobility restrictions have been posing challenges in the conduct of PIF Audits. Considering this, the FDA devises off-site audit as a feasible audit option. According to the Updated Guidelines, the off-site audits may occur in any of the following manner as determined by the FDA:

1. Synchronous remote PIF Audit: audits performed off-site, where documents are presented by the MAH to the PIF Auditor, and reviewed, through a live audit session assisted by information and communication technology platforms.
2. Desktop PIF Audit: audits performed remotely by reviewing the required documents submitted by the MAH.

3. Specifying the Treatment to Non-conformances in PIF Audits

During PIF Audits, it is found that a number of MAHs are non-compliant to the PIF requirement. Violations range from an incomplete PIF to completely without PIF for cosmetic products already placed in the market. To ensure the transparency, clarity and efficiency in dealing with these non-conformances, the Updated Guidelines details the classification, definition and resolution to them.

Besides, the Updated Guidelines compiles an illustrative, non-exhaustive list of PIF Audit deficiencies in Annex B, which list will be constantly updated. The current version can be find here.

Further Reading

• ASEAN Introduces Amendments to the Ingredient Lists of ACD: 3 New Ingredients Included and 13 Ingredients Revised
• [Updated] Philippines to Modify the Requirements for Licensing and Inspection of Health Products, Cosmetics Included

Reference Links

[1]FDA Circular No.2023-0001 || Updated Guidelines on Product Information File (PIF) for Cosmetic Products Repealing FDA Circular No. 2018-001 “Reiterating the Mandatory Implementation of Article 8 of the ASEAN Cosmetic Directive ‘Product Information’”

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