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.

“The pace of in­no­va­tion in med­ical de­vices has sur­passed med­i­cines due adapt­able ap­proach­es to the reg­u­la­tion of in­no­v­a­tive prod­ucts. While the ex­ist­ing nov­el li­cenc­ing path­ways for med­i­cines have seen pos­i­tive re­sults in pro­vid­ing time­ly pa­tient ac­cess, cur­rent and up­com­ing in­no­va­tions will con­tin­ue to chal­lenge reg­u­la­tors,” the re­port notes.

Eu­ro­pean, Japan­ese and Sin­ga­pore drug reg­u­la­tors al­so fur­ther ex­plored the top­ics of ad­di­tive man­u­fac­tur­ing, genome edit­ing and AI.

“The prod­ucts and tech­nolo­gies ex­plored in the case stud­ies show that many reg­u­la­to­ry sci­ence tools are miss­ing at present (e.g. off-tar­get ef­fects de­tec­tion meth­ods) and must be de­vel­oped in or­der for reg­u­la­tors to be able to as­sess the prod­ucts across their life-cy­cle. In ad­di­tion, new tech­nolo­gies (such as ad­di­tive man­u­fac­tur­ing) re­quire adap­ta­tion of the ex­ist­ing reg­u­la­to­ry frame­works, as they fa­cil­i­tate the pro­duc­tion of more com­plex prod­ucts at the point of care rather than in ded­i­cat­ed man­u­fac­tur­ing sites,” the re­port adds.

Reg­u­la­tors will need to train staffers on the new prod­uct types, but will al­so have to ac­cess out­side ex­perts (e.g., soft­ware en­gi­neers), who will re­quire reg­u­la­to­ry train­ing, as well. The agen­cies pro­posed de­vel­op­ing a ca­pac­i­ty frame­work for ex­per­tise as a com­mon re­source, fea­tur­ing the map­ping of the re­quired skills and ex­per­tise for var­i­ous types of prod­ucts or tech­nolo­gies to as­sist reg­u­la­tors in iden­ti­fy­ing their ca­pac­i­ty needs.

ICM­RA, which is al­so look­ing to es­tab­lish an in­for­mal in­no­va­tion net­work among ICM­RA mem­bers lat­er this year, will seek to bet­ter ar­tic­u­late the com­mon char­ac­ter­is­tics of nov­el reg­u­la­to­ry path­ways and to as­sist the analy­ses and con­sid­er­a­tions of new and ex­ist­ing reg­u­la­to­ry meth­ods.

In ad­di­tion to the strate­gic pri­or­i­ty project re­port on in­no­va­tion, ICM­RA re­cent­ly re­leased a frame­work for the in­volve­ment of health au­thor­i­ties in the man­age­ment of glob­al health crises.

In­no­va­tion Strate­gic Pri­or­i­ty Pro­ject Re­port

First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. Click here for more in­for­ma­tion.

Im­age: Shut­ter­stock


Zachary Brennan

managing editor, RAPS

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