The Application of Regulatory Science in Marketing Authorization of Biological Products

Abstract

Objective: To compare marketing authorization (MA) process for biological products between Thailand and European Union (EU)/United States of America (USA) by using regulatory science as a tool for evaluation. Methods: This research was a documentary study using objectives of regulatory science as a framework for analysis and comparison of MA process between Thailand and EU/USA. The researcher presented the analysis results to experts on drug system and drug consumer protection to critique and improve the results. Results: Three big gaps of the MA process for biological products in Thailand and those in EU/USA were identified as followed; 1) Thailand did not specify guidelines for reviewing drugs for pediatric and infants and had no regulation to promote clinical trials in children. 2) Thailand had a few guidelines for counteracting public health crisis and most of them were for pandemic influenza situation.  They were not suitable for other case of public health crisis. 3) Thailand had limited guidelines for biological products registration which were not specific and did not cover the variety of biological products. Conclusion: The MA process improvement should be in 3 phases, i.e., short term phase, medium-term phase and long-term phase. The concept on quality cycle and regulatory research should be applied to the improvement effort.