The FDA is ready to register monkeypox diagnostic test kits to support the expanding global outbreak situation by developing guidelines for evaluating the quality, standards, and safety of test kits. This is to ensure that the public can access disease diagnosis quickly and comprehensively.
Pharmacist Lertchai Lertwutthi, Deputy Secretary-General of the Food and Drug Administration, revealed that after the World Health Organization (WHO) declared monkeypox a Public Health Emergency of International Concern (PHEIC), the Food and Drug Administration (FDA) has prepared to register monkeypox diagnostic test kits (MPOX) to support the situation by creating guidelines for assessing the quality, standards, and safety of monkeypox diagnostic test kits. The goal is to enable manufacturers and importers of test kits to prepare necessary documents correctly and in accordance with the requirements, such as efficacy and safety test reports, reference standards, making the registration process fast and efficient so that
the public can access disease diagnosis quickly and widely. The FDA has registered monkeypox diagnostic test kits, and the products can be checked at https://medical.fda.moph.go.th/
The FDA Deputy Secretary-General added that having quality standard test kits in the country will help reduce the public health burden in the long run by controlling and suppressing the outbreak from the beginning. Rapid detection and treatment will help reduce the number of new infections and prevent the spread of the disease to the community, making the Thai public health system more stable and ready to deal with future monkeypox situations more effectively. The FDA, through the One Stop Service Center for Health Products, has opened a specific service point to support the registration of test kits to make the registration service convenient and fast. For more information, please visit the website of the FDA’s Medical Device Control Division at
https://medical.fda.moph.go.th/press-release/newsmpox/ or via the QR Code
Source:
Thai News Agency