The Euro­pean Union is tak­ing steps to sim­pli­fy the sub­mis­sion and approval process for stud­ies involv­ing med­i­c­i­nal prod­ucts, in vit­ro diag­nos­tics (IVDs), and med­ical devices. The goal is to remove bot­tle­necks and cre­ate a more effi­cient sys­tem, ensur­ing that multi­na­tion­al stud­ies can pro­ceed with­out unnec­es­sary delays. To achieve this, reg­u­la­tors have launched sev­en cross-sec­tor projects, each aimed at improv­ing dif­fer­ent aspects of the approval process.

The COMBINE ini­tia­tive, which start­ed in 2023, is a col­lab­o­ra­tive effort between EU nation­al author­i­ties, the Euro­pean Com­mis­sion, and key indus­try stake­hold­ers. The first phase of the project was com­plet­ed in May 2024, result­ing in a detailed analy­sis of the chal­lenges in con­duct­ing com­bined stud­ies. Based on these find­ings, EU mem­ber states endorsed a strate­gic plan in Decem­ber 2024 to move into the sec­ond phase.

One of the most sig­nif­i­cant projects focus­es on devel­op­ing a uni­fied assess­ment process for appli­ca­tions relat­ed to com­bined stud­ies. This means that clin­i­cal tri­als involv­ing both drugs and com­pan­ion diag­nos­tics or IVDs, will be eval­u­at­ed more effi­cient­ly across mul­ti­ple EU mem­ber states. A pilot study, run­ning from mid-2025 to mid-2026, will inte­grate the drug tri­al and med­ical tech­nol­o­gy study por­tals (CTIS and EUDAMED), mak­ing sub­mis­sions and approvals more streamlined.

Anoth­er key project seeks to opti­mize adverse event report­ing for com­bi­na­tion tri­als. Cur­rent­ly, there is con­fu­sion between dif­fer­ent reg­u­la­to­ry frame­works (MDR, IVDR, and CTR) regard­ing how to report seri­ous safe­ty con­cerns. A study start­ing in ear­ly 2025 will com­pare exist­ing safe­ty report­ing pro­ce­dures and devel­op clear guide­lines to ensure that report­ing is con­sis­tent and effec­tive across all sectors.

A third project will align reg­u­la­to­ry frame­works by har­mo­niz­ing how the Clin­i­cal Tri­al Reg­u­la­tion (CTR), Med­ical Devices Reg­u­la­tion (MDR), and In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (IVDR) are applied to key issues. These issues include ear­ly ter­mi­na­tion of stud­ies, reg­u­la­to­ry pro­ce­dures for IVDs in dif­fer­ent tri­als, and respon­si­bil­i­ties of spon­sors and man­u­fac­tur­ers. This work is expect­ed to lead to new guide­lines by ear­ly 2027.

Oth­er projects aim to clar­i­fy the role of med­ical devices and IVDs in drug tri­als, pro­vide guid­ance for study spon­sors, and cre­ate train­ing pro­grams for reg­u­la­to­ry author­i­ties and ethics com­mit­tees. Addi­tion­al­ly, a cen­tral­ized repos­i­to­ry of nation­al reg­u­la­to­ry require­ments will be cre­at­ed by 2025 to help spon­sors under­stand dif­fer­ent approval process­es across EU countries.

The COMBINE ini­tia­tive was devel­oped in response to con­cerns from phar­ma­ceu­ti­cal com­pa­nies about delays in drug tri­als, par­tic­u­lar­ly in oncol­o­gy and rare dis­eases, due to the chal­lenges of com­ply­ing with the IVDR. Since IVDs are essen­tial for detect­ing dis­eases and mon­i­tor­ing patients in clin­i­cal tri­als, their reg­u­la­to­ry assess­ment is cru­cial. How­ev­er, the lack of coor­di­na­tion in per­for­mance study appli­ca­tions has caused setbacks. 

By imple­ment­ing these reforms, the EU aims to cre­ate a more coor­di­nat­ed and effi­cient sys­tem for man­ag­ing com­bi­na­tion prod­uct stud­ies. This ini­tia­tive will ben­e­fit both researchers and patients by reduc­ing delays, ensur­ing clear­er reg­u­la­to­ry path­ways, and improv­ing col­lab­o­ra­tion between drug and med­ical device sectors.

Source: Medtech Insight (an Infor­ma product)

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