Simpler Appro Procedures Mooted For Japan

Japan's Office of Trade and Investment ombudsman (OTO) has made recommendations on the simplification of approval procedures for over-the-counter medicines and in vitro diagnostics.

Among its recommendations are that administrative procedures should be simplified and the time required for approval and licensing should be shortened, according to Pharma Japan, as well as that the approval and licensing systems in Japan be brought into greater harmony with those in other countries. It also suggests that studies be initiated to classify drugs and in vitro diagnostics into different categories in the manufacturing/import approval process in line with demands from various foreign organizations.

US-Style OTC System? With respect to the approval and licensing of OTC medicines, the American Chamber of Commerce in Japan has been asking the Japanese government to introduce a reporting system similar to the one used in the USA.