Keeping up with all the regulations is one of my most critical responsibilities as a regulator at the Thai FDA. Organizational interoperability issues arise as the agency’s information ecosystems become more complex. Since the agency regulates a wide range of health items, several regulations have evolved over time, and each division just keeps updating them on its website. Systems and methods are lacking for managing the information landscape logically and conceptually. There is no doubt that a lack of interoperability causes organizational confusion.
According to what I know, the agency has been working to create a new information system for the past five years. The software has been created to work with current data and hardware. The two most difficult components to make the system function effectively, in my opinion, are the procedures and the people (referred to as the five components covered in our week 1-1 session).