1979
The National Health Products Quality Control Center, formerly known as the Drug Quality Control Laboratory, was established around 1979 within the state-owned pharmaceutical manufacturer Dumex to analyze the quality of pharmaceutical products produced by state-owned pharmaceutical manufacturers, including Dumex, PAK, ENAPHAR, and the Traditional Medicine Center. At that time, the laboratory operated with only approximately 4 to 5 staff members and utilized old laboratory equipment and materials remaining from the Khmer Rouge regime.
Early
1983
In early 1983, the Drug Quality Control Laboratory was relocated to Building No. 8, Oung Phalgun Street, Mittapheap Sangkat, 7 Makara District (former site of the old Department of Drugs), with approximately 10 to 15 staff members.
1993
In 1993, the Drug Quality Control Laboratory collaborated with the World Health Organization, UNICEF, the French Embassy, and Pharmacists Without Borders to strengthen staff capacity in pharmaceutical quality analysis and research.
1995
In 1995, the Drug Quality Control Laboratory relocated to Lot No. 36, Georges Dimitrov Boulevard, Mittapheap Sangkat, 7 Makara District, occupying the first and second floors of the PAK/CPE pharmaceutical manufacturing facility. In line with the Ministry of Health's policy requiring drug registration approval prior to market distribution, the number of staff increased to more than 20 employees.
1998
In 1998, the Drug Quality Control Laboratory became a health institution with a status equivalent to a department under the Ministry of Health. From that time onward, the laboratory continuously received support in the form of laboratory equipment, including analytical balances and pre-owned HPLC systems, from the Japan Pharmaceutical Manufacturers Association (JPMA/JICA). Staff members also benefited from both short- and long-term training programs in Japan and other ASEAN countries.
2008
In 2008, the Drug Quality Control Laboratory was transformed into a Public Administrative Institution and officially renamed the "National Health Products Quality Control Center" under Sub-Decree No. 06 អនក្រ.បក dated 24 January 2008.
2009
In 2009, the National Health Products Quality Control Center relocated to Lots No. 152–153, Kampuchea Krom Boulevard, within the Ministry of Health compound, Mittapheap Sangkat, 7 Makara District, Phnom Penh.
2016
From 2016 to the present, the National Health Products Quality Control Center has been located at Building No. 245H, National Road No. 6A, Phum Kien Khleang, Prek Leap Sangkat, Chroy Changvar District, Phnom Penh, with a total workforce of 76 officials and staff members.
2019
Since 2019, the National Health Products Quality Control Center has operated as a Public Administrative Institution under Sub-Decree No. 233 អនក្រ.បក dated 27 December 2019.
- To be internationally recognized for testing, verification, and calibration laboratory services.
- To become a compliant reference laboratory comparable to other ASEAN reference laboratories for the testing, verification, and certification of health products, including pharmaceuticals, health supplements, cosmetics, food products, and other related products.
- To serve as a research and training center for the quality control of health products and related products, including pharmaceuticals, health supplements, cosmetics, and food products.
- Conduct research and quality control on the quality, efficacy, and safety of health products and related products, including health supplements, traditional medicines, medical devices, cosmetics, and food products.
- Provide innovative and timely quality control testing and verification laboratory services that meet customer needs and comply with international standards and guidelines, including ISO/IEC 17025 and World Health Organization guidelines.
- Continually improve the effectiveness of the quality management system.
- Protect consumers and enhance public health by maximizing compliance with regulated products and minimizing risks associated with those products.
- Uphold the values of quality, integrity, innovation, accountability, collaboration, and leadership.
The National Health Products Quality Control Center upholds core values of quality, integrity, innovation, accountability, and collaboration to ensure the delivery of analytical services in accordance with international standards and to contribute effectively to the protection of public health.
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4. QUALITY MANAGEMENT SYSTEM
The National Health Products Quality Control Center implements a quality management system based on the ISO/IEC 17025:2017 standard and the guidelines of the World Health Organization, in accordance with WHO Technical Report Series No. 1052, Annex 4 (2024), WHO Technical Report Series No. 996, Annex 5 (2016), and other relevant quality management documents. These systems are applied in line with current requirements for the testing and analysis of pharmaceutical and health products.
The organizational structure of the National Health Products Quality Control Center is organized into five divisions:
- Physico-Chemical Laboratory
- Microbiological Laboratory
- Metrology Laboratory
- Research and Development Laboratory
- Food Laboratory
The National Health Products Quality Control Center has been internationally accredited under the ISO/IEC 17025 standard for its Physico-Chemical and Microbiology Laboratories, in accordance with Accreditation Certificate No. VILAS 1512, since October 2023. Additionally, in November 2025, the Physico-Chemical Laboratory was officially recognized as compliant with World Health Organization Prequalification (WHO-PQ) standards and was included in the WHO List of Prequalified Medicines Quality Control Laboratories, becoming one of 66 recognized laboratories worldwide.