Japan considers adjusting clinical trial requirements to remove the need for local studies — report

Japan is re­think­ing its clin­i­cal tri­al re­quire­ments to ad­dress a lag in Japan­ese ap­provals for new drugs that are al­ready avail­able in oth­er coun­tries, ac­cord­ing to the fi­nan­cial news out­let Nikkei.

In the next few months, the coun­try is ex­pect­ed to lift a rule re­quir­ing ad­di­tion­al safe­ty stud­ies with Japan­ese par­tic­i­pants be­fore a drug can be mar­ket­ed, Nikkei re­port­ed, cit­ing un­named sources.

Japan has been grap­pling with a so-called “drug lag” for decades, in which drugs ap­proved in the US and Eu­rope can take much longer to ar­rive on the Japan­ese mar­ket for a num­ber of rea­sons, in­clud­ing clin­i­cal tri­al re­quire­ments.

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