The Thai FDA and the Australian TGA signed an Exchange of Letter to extend the scope and the duration of cooperation in developing the standards for regulating pharmaceutical products and medical devices. The extension followed successful evaluation techniques for many pharmaceutical formulations which allow access to effective and safe medicines.

           Today (20 February 2024), the Food and Drug Administration (FDA), together with the Therapeutic Goods Administration (TGA) – Australia’s medical product regulatory agency – led by Mr. Michael Wiseman, the Assistant Secretary, International Regulatory Branch, held an Exchange of Letter signing ceremony to extend the scope and duration of the Indo-Pacific RSP Project to 2027. The two parties first signed a memorandum of understanding regarding cooperation on therapeutic products in 2021. Past collaborations include TGA’s technical assistance in the evaluation for the registration of malaria treatment medicine (Tafenoquine), gene therapy product for treatment of spinal muscular atrophy in children (Zolgensma), and antiretroviral medicine (Pifeltro). As a result of such collaboration, Thai people gained access to quality and effective medicines. In addition, TGA also supported the development of the electronic document submission system for modern medicine registration – the Thai RIMS – to facilitate enterpreneurs in their registration process.

           Dr. Narong Aphikulvanich, the Secretary-General of the Food and Drug Administration (FDA), revealed that today’s cooperation is a crucial step for Thai FDA and TGA towards a shared path to excellence in regulatory standards. The goal towards such excellence is to meet internationally recognized standards and to represent a global effort to ensure the safety and efficiency of medical products. TGA has been an important partner helping Thai FDA towards an internationally recognized regulatory excellence. By leveraging both countries’ expertise in product regulations, and by strengthening the capacity to regulate medical products in terms of quality, safety, efficiency, and risk communication, patients are granted access to timely quality and safe products.      

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                                                                                Publication Date: 20 February 2024