The EU has launched a pilot project to sim­pli­fy approvals for com­bined drug and diag­nos­tic tri­als. Instead of two sep­a­rate appli­ca­tions per mem­ber state, spon­sors can now sub­mit one coor­di­nat­ed dossier, reduc­ing com­plex­i­ty and speed­ing up patient access to new therapies.

Cur­rent Challenges

Under today’s sys­tem, each com­bined study needs sep­a­rate approvals under the Clin­i­cal Tri­als Reg­u­la­tion (CTR)and the In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (IVDR). This dual process often delays tri­als, espe­cial­ly in oncol­o­gy and rare dis­eases, because IVDs—critical for patient monitoring—must under­go per­for­mance study assess­ments that don’t align with drug tri­al timelines.

Pilot Fea­tures

Start­ing June 13, the pilot uses the exist­ing EU Clin­i­cal Tri­als Infor­ma­tion Sys­tem (CTIS) as a sin­gle por­tal for:

1. Part I of the study dossier under the Clin­i­cal Tri­als Reg­u­la­tion (CTR) focused on spe­cif­ic require­ments relat­ed to the med­i­c­i­nal prod­uct to facil­i­tate clin­i­cal tri­al assess­ment by nation­al com­pe­tent authorities.

2. Part II of the study dossier under the CTR, con­cern­ing nation­al and patient-lev­el require­ments, to sup­port clin­i­cal tri­al assess­ment by nation­al ethics committees.

3. Autho­ri­sa­tion of per­for­mance stud­ies under the In Vit­ro Diag­nos­tic Reg­u­la­tion (IVDR) by applic­a­ble nation­al authorities.

4. Eth­i­cal opin­ions for per­for­mance stud­ies under the IVDR by nation­al ethics committees.

Deci­sions on both drug and diag­nos­tic com­po­nents will fol­low the CTR’s 81-day dead­line, with only one round of infor­ma­tion requests. Spon­sors still sub­mit a nation­al IVD appli­ca­tionon day 69 to sat­is­fy IVDR legalities.

Next Steps

The pilot’s first phase will assess up to five multi­na­tion­al tri­als, with results due by ear­ly 2026. Spon­sors inter­est­ed in par­tic­i­pat­ing must apply by August 31. This COMBINE ini­tia­tive, active since June 2023, seeks to resolve reg­u­la­to­ry bot­tle­necks and pave the way for a stream­lined, har­mo­nized review process across the EU.

Source: Medtech Insight (an Infor­ma product)

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website