Drug reg­u­la­tors look to har­mo­nize how they tack­le in­no­va­tion

The In­ter­na­tion­al Coali­tion of Med­i­cines Reg­u­la­to­ry Au­thor­i­ties (ICM­RA) re­cent­ly re­leased a re­port on how var­i­ous reg­u­la­tors world­wide are work­ing to­geth­er to bet­ter iden­ti­fy and ad­dress fu­ture reg­u­la­to­ry chal­lenges posed by new cat­e­gories of ther­a­peu­tics, like cell and gene ther­a­pies, and new tools for drug de­vel­op­ment, such as ar­ti­fi­cial in­tel­li­gence (AI).

The re­port, which is part of a wider ef­fort to re­duce du­plica­tive work and in­crease har­mo­niza­tion among drug reg­u­la­tors from the US, Eu­rope, Japan and else­where, delves in­to the top­ic of hori­zon scan­ning for new in­no­va­tions, which for most reg­u­la­tors is “still in its in­fan­cy.” The re­port al­so ad­dress­es nov­el reg­u­la­to­ry path­ways, such as ex­pe­dit­ed path­ways, and oth­ers re­lat­ed to ear­ly en­gage­ment with stake­hold­ers, such as Health Tech­nol­o­gy As­sess­ment agen­cies.

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