The Philippine Food and Drug Administration (FDA), as the National Regulatory Authority (NRA), is the gatekeeper of the supply chain of pharmaceutical products in the country. By virtue of Republic Act No. 9711, otherwise known as the Food and Drug Administration Act of 2009, it is mandated to ensure the safety, efficacy, and quality of medicines including vaccines and biological products.
In its desire to reach a level of maturity, whereby it will have a secure, well-functioning, and integrated regulatory system, the agency fully coordinated with the World Health Organization (WHO) for the assessment process using the WHO Global Benchmarking Tool (GBT) Kit. On 19-20 October 2023, WHO Assessors conducted the evaluation process in FDA Regional Office IV-A located in Calamba City, Laguna. The WHO Team assessed the FDA Main Office in Alabang, Muntinlupa City on 23-27 October 2023.
The Global Benchmarking Tool (GBT) represents the primary means by which the World Health Organization (WHO) objectively evaluates regulatory systems, as mandated by World Health Assembly (WHA) Resolution 67.20 on Regulatory System Strengthening for medical products.
The GBT is a necessary tool for creating strong and effective regulatory systems, which are critical for ensuring the safety, efficacy, and quality of medicines and the public’s timely access to these medicines. The purpose of the tool is to evaluate the regulatory framework and the regulatory functions that compose it such as the national regulatory system, registration and marketing authorization, vigilance, market surveillance and control, licensing establishments, regulatory inspection, laboratory testing, clinical trials oversight, and NRA lot release, through a series of sub-indicators. The preferred maturity level for a country’s national regulatory system is maturity level 3. Using the tool, National Regulatory Authorities (NRAs) can benchmark their own strengths and areas of weakness, and then engage in a formal benchmark process together with the WHO and international experts to formulate an effective and workable institutional development plan.
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