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The Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) is soliciting comments on the proposed policy, provisionally entitled “Guidelines on the Filing and Submission of Acceptable Variations on Protocols and Non-standard Protocols for the Review and Pre-Approval by the Food and Drug Administration Prior to the Conduct of Bio-efficacy Test Studies of Household Pesticides for the Purposes of Securing a Certificate of Product Registration”.

The proposed issuance aims to improve the regulatory compliance of pesticide registration applications and facilitate the same through the establishment of a pathway for the review and pre-approval of non-standard and modified bio-efficacy test protocols.

All concerned stakeholders, including Household/Urban Pesticide (HUP) Manufacturer, Distributor and Trader, and other HUP-related establishments, are requested to may submit comments in MSWord Format via email to cchuhsrr-policy@fda.gov.ph on or before 29 July 2022 using the “Template for comments” attached below.

I. RATIONALE

Pesticide registration involves an evaluation of comprehensive scientific data demonstrating that a pesticide is effective for its intended purposes and does not pose an unacceptable risk to human or animal health or the environment. In particular, the aspect of pesticide registration which reviews the effectiveness of a pesticide is the technical evaluation of the submitted bio-efficacy study. Following Department of Health (DOH) Administrative Order (AO) No. 2019-0008, entitled, “New Rules and Regulations in the Registration of Household Pesticide Products and their Active Ingredients”, accepted protocols have been identified and that any deviation from standard protocols require sufficient and compelling justification to ensure soundness of the method and the reliability to produce data to support product claims.

In the course of the implementation of the said AO, updates to the internationally-accepted standards suggest that changes to the list of accepted protocols must be made. Additionally, an assessment of the implementation of the AO showed that pesticide registration applications were found to display deficiencies in the submitted bio-efficacy test study which resulted in disapproved applications. Such applications displayed failure to substantiate claims and failure to justify modifications to accepted standards. In order to assist market authorization applicants, promote regulatory compliance, and ensure the efficient use of resources, this Circular hereby establishes the pre-approval process for modified and non-standard bio-efficacy test protocols.

II. OBJECTIVES

This Circular aims to improve the regulatory compliance of pesticide registration applications and facilitate the same through the establishment of a pathway for the review and pre-approval of non-standard and modified bio-efficacy test protocols, which will be submitted in support of pesticide registration under DOH AO No. 2019-0008

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