Development of the Clinical Trial Authorization Guideline and Clinical Research Network in Thailand

Abstract

Background: The regulatory oversight of clinical trials of pharmaceutical products is a key responsibility of the Thai Food and Drug Administration (Thai FDA) as the national regulatory authority for medicines in Thailand. This function plays a crucial role in protecting the rights, safety, and well-being of research participants, ensuring the credibility and reliability of clinical research data used to support drug registration, and facilitating evidence-based regulatory decision-making throughout the lifecycle of pharmaceutical products.

Objectives: This study aimed to develop regulatory and authorization guidelines for clinical trial and to strengthen the clinical trial network in Thailand.

Methods: This study employs a combination of descriptive and developmental research. The framework was based on Regulatory Science concepts, applying the PDCA (Plan–Do–Check–Act) cycle to analyze regulations and international standards. The study also incorporated the World Health Organization’s Global Benchmarking Tool (WHO GBT) assessments of the Thai FDA’s clinical trial functions, alongside consultations with various stakeholders.

Results: The study resulted in the development of a structured framework for the clinical trial authorization process suitable for the Thai FDA. The framework comprises four key components: (1) standards for clinical studies conducted to support drug registration, (2) procedures for clinical trial authorization, (3) post-authorization regulatory oversight, and (4) regulatory inspection practices for clinical trials. In parallel, discussions were initiated with relevant stakeholders to establish a collaborative clinical research network aimed at promoting clinical research activities in Thailand.

Conclusions: The results of this study represent important mechanisms for strengthening Thailand’s regulatory system for clinical trials of medicinal products. These developments enhance clarity, transparency, and alignment with international standards, while supporting evidence-based regulatory decision-making and contributing to the sustainable development of the pharmaceutical research and development ecosystem in Thailand.