Chapter 12 - Development of Regulatory Capacity in Monitoring, Oversight, Enforcement, and Approval of Clinical Trials: Taiwan’s Experience as an Example

Abstract

To protect people's health, every step in the development of a new drug is highly regulated based on best international practice and local regulatory requirements. Developing the capacity and capability of the national regulatory authority (NRA) is a priority in many countries, to ensure the safety and efficacy of drugs while supporting the development of innovative medicines such as the H1N1 vaccine. There have been rapid developments in the methodology of clinical trial study design and regulation, ethical principles, and marketing registration. The trend towards simultaneous global drug development and regulatory convergence has included a focus on bringing the conduct of the clinical trial and its regulatory capacity up to best international practice, especially in emerging countries. Taiwan has come far to attain its current capacity and capability in regulatory science, and serves as a good reference for other NRAs in developing a regulatory system to protect and promote public health.