Re-evaluation of drugs is underway. The move is aimed at preventing waste of health insurance benefits due to insufficient drugs to verify efficacy. Accordingly, the MFDS is playing a leading role in re-evaluating clinical trials and the HIRA is playing a leading role in re-evaluating the adequacy of benefits. The problem is that there is no consistency in selecting the target drug as the re-evaluation is carried out separately.

The MFDS goes through clinical re-evaluation procedures if it fails to prove that it is currently not used in developed countries, the United States, the United Kingdom, France, Italy, Japan, Germany, Switzerland, and Canada, called A8 during the license renewal process.