Development of National Compliance Monitoring Authority to OECD GLP Mutual Acceptance of Data on Chemical Assessment

Development of Compliance Monitoring Authority to OECD GLP Mutual Acceptance of Data on Chemical Assessment

Authors

  • Thunyarat Sooksomboon Bureau of Laboratory Quality Standard, Department of Medical Sciences
  • Sarinee Lenapun Bureau of Laboratory Quality Standard, Department of Medical Sciences
  • Surasak Muenphon Bureau of Laboratory Quality Standard, Department of Medical Sciences

Keywords:

National Compliance Monitoring Authority, Mutual Acceptance of Data in the Assessment of Chemicals, Organization for Economic Co-operation and Development, Test Facility

Abstract

         In 2010, the National Assembly of Thailand decided for the country to become a provisional adherent of the Organization for Economic Co-operation and Development (OECD). This decision was made in relation to the Council Acts related to the Mutual Acceptance of Data (MAD) in the Assessment of Chemicals, with important conditions for the National Compliance Monitoring Authority (CMA) to undergo OECD evaluations. The Bureau of Laboratory Quality Standards, Department of Medical Sciences, as the National Compliance Monitoring Authority (CMA) in Thailand, has developed objectives to pass the on-site evaluation and become a full adherent to the MAD. The development comprised important components simultaneously: CMA (inspectors, personnel, GLP compliance program, and the archive system), as well as test facility compliance with the OECD Principles of Good Laboratory Practice (GLP), OECD Test guidelines, and OECD Council Acts. As a result, in 2018, CMA underwent an on-site evaluation by OECD members. On September 7, 2020, the OECD Council decided that Thailand to become a full adherent to MAD. The benefits as a full adherent were providing the same rights and obligations in Mutual Acceptance of Data (MAD) in the Assessment of Chemicals without duplicative testing, saving time and resources, help to avoid the creation of technical trade barriers, and further improve the protection of human health and the environment, and it is increasing the potential of sponsors to be more competitive in the international trade. Now in 2025, 7 test facilities have been registered in compliance with OECD GLP. However, CMA is further required for continuous development to upgrade operation standards to the same level as other OECD members.

References

Organisation for Economic Co-operation and Development (OECD). Testing of chemicals. [online]. [cited 2022 Jun 9]. Available from: URL: https://www.oecd.org/en/topics/testing-of-chemicals.html.

Organisation for Economic Co-operation and Development (OECD). Mutual acceptance of data system. [online]. [cited 2022 Jun 9]. Available from: URL: https://www.oecd.org/en/topics/sub-issues/testing-of-chemicals/mutual-acceptance-of-data-system.html.

Organisation for Economic Co-operation and Development (OECD). Decision of the Council concerning the mutual acceptance of data in the assessment of chemicals, OECD/LEGAL/0194. Paris: OECD; 1981.

Organization for Economic Co-operation and Development (OECD). Decision-recommendation of the Council on compliance with principles of good laboratory practice, OECD/LEGAL/0252, Paris: OECD; 1989.

Organisation for Economic Co-operation and Development (OECD). Good laboratory practice and compliance monitoring. [online]. [cited 2024 Dec 9]. Available from: URL: https://www.oecd.org/en/topics/sub-issues/testing-of-chemicals/good-laboratory-practice-and-compliance-monitoring.html.

ประชาสรรณ์ แสนภักดี. ผังก้างปลากับแผนภูมิความคิด. [ออนไลน์]. 2565; [สืบค้น 9 มิ.ย. 2565]; [4 หน้า]. เข้าถึงได้ที่: URL: http://www.prachasan.com/mindmapknowledge/fishbonemm.htm.

Organization for Economic Co-operation and Development (OECD). OECD principles on good laboratory practice. Paris: OECD; 1998.

Organization for Economic Co-operation and Development (OECD). Guidance for GLP monitoring authorities, revised guides for compliance monitoring procedures for good laboratory practice. Paris: OECD; 1995.

Organization for Economic Co-operation and Development (OECD). Guidance for GLP monitoring authorities, revised guidance for the conduct of laboratory inspections and study audits. Paris: OECD; 1995.

Organization for Economic Co-operation and Development (OECD). Guidance for the Preparation of GLP Inspection reports. Paris: OECD; 1995.

Organization for Economic Co-operation and Development (OECD). Guidelines for the testing of chemicals No. 423: acute oral toxicity - acute toxic class method. Paris: OECD; 2001.

Organisation for Economic Co-operation and Development (OECD). National GLP compliance monitoring programmes which participate in the Mutual Acceptance of Data (MAD) system: status and contact information. [online]. [cited 2021 Jan 8]; [24 screens]. Available from: URL: https://www.oecd.org/content/dam/oecd/en/topics/policy-sub-issues/testing-of-chemicals/national-glp-compliance-monitoring-programmes-which-participate-in-the-mutual-acceptance-of-data.pdf.

Bureau of Laboratory Quality Standards, Department of Medical Sciences. Manual for Thailand GLP compliance programme. Nonthaburi: Bureau of Laboratory Quality Standards, Department of Medical Sciences; 2024.

Bureau of Laboratory Quality Standards, Department of Medical Sciences. List of test facilities registered to National OECD GLP compliance programme. [online]. 2024; [cited 2025 Apr 14]. Available from: URL: https://blqs.dmsc.moph.go.th/page-view/129.

Downloads

Published

23-12-2025

How to Cite

1.
Sooksomboon T, Lenapun S, Muenphon S. Development of National Compliance Monitoring Authority to OECD GLP Mutual Acceptance of Data on Chemical Assessment: Development of Compliance Monitoring Authority to OECD GLP Mutual Acceptance of Data on Chemical Assessment. ว กรมวิทย พ [internet]. 2025 Dec. 23 [cited 2026 Mar. 12];67(4):723-40. available from: https://he02.tci-thaijo.org/index.php/dmsc/article/view/275515