The European Medicines Agency is looking to foster the uptake of organ-on-chip (OoC) models and other microphysiological systems (MPS) in drug development and regulatory submissions, according to its planned revision of its seven-year-old guideline on the replacement, reduction and refinement (3Rs) of animal studies.
EMA To Address Challenges Of Using Organ-On-Chip Models In Drug Development
Microphysiological systems such as organ-on-chip models could not only improve the translational success of drug candidates into the clinic, but also impact the 3Rs in non-clinical safety testing, according to the European Medicines Agency.

More from R&D
Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.
South Korea announces planned revisions to a government scheme to designate "innovative" biopharma companies amid allegations of "discrimination" against foreign firms.
The new global GCP guideline, ICH E6(R3), enables researchers and clinical trial administrators to tailor their documentation processes, but also opens the door for more scrutiny during GCP inspections.
The European Medicines Agency’s qualification of the AIM-NASH tool is said to signify a major advancement for clinical trials for metabolic dysfunction-associated steatohepatitis. The market size for MASH treatments is expected to grow substantially in the coming years.
More from Pink Sheet
Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.
England’s health technology assessment institute, NICE, is looking to “reimagine” its evaluation process with the help of AI, rather than just using this technology to speed up its existing processes.
Industry lobbing for pharmaceuticals to be exempt from President Trump’s sweeping US tariffs appears to have paid off.