On 9 September 2026, the first Asia-Pacific summit of the International Alliance for Microphysiological Systems opened in Nanjing — an event that for the first time brought the global discussion of organoids and organs-on-chips beyond Europe and the United States.
The focus is not so much on the technologies themselves as on their path from laboratory prototypes to real-world use in drug development. Regulators in the United States and China are simultaneously easing requirements for animal testing, and this creates a window of opportunity that Chinese researchers intend to be the first to seize.
Today, in 2025, the FDA published a roadmap for the gradual phasing out of animal tests in the development of monoclonal antibodies, and the US National Institutes of Health allocated more than 150 million dollars to alternative methods. In China, in July 2026, the State Drug Administration launched a pilot project that directly includes organoids and organs-on-chips in the safety assessment of drugs.
Chinese experts emphasize that technical maturity is no longer the main obstacle. It is far more difficult to ensure the reproducibility of data and their acceptance by regulators. Organoids are easier to standardize in terms of structure and cellular composition, whereas organs-on-chips require precise control of physiological functions — contraction frequency, signal conduction, metabolism. It is precisely here that the gap between a laboratory result and a safety requirement remains most noticeable.
A cardiac chip serves as an example: it records the frequency and amplitude of contractions and the speed of impulse conduction. These parameters make it possible to predict how a substance will affect the human heart rhythm. However, to fully replace toxicological tests on animals, such data are not yet sufficient — regulators demand evidence that the chip captures rare but dangerous side effects that manifest in only a small proportion of patients.
In Nanjing, simultaneously with the summit, the country's first specialized center for the transfer of organ-on-chip technologies opened. Agreements were also signed there with three major companies on joint work on data generation, quality control, and entry into international markets. The project leader from Southeast University notes that industrialization runs up not against equipment but against people capable of translating a laboratory protocol into serial production and a regulatory dossier.
China possesses two competitive advantages — advanced micro- and nanofabrication capacities and a huge domestic market. If in the next five years it manages to create a sustainable system of high-quality, standardized human data, the country may indeed emerge as a leader. For now, however, the main uncertainty is how quickly regulators in different countries will agree to accept these data as a full-fledged replacement for classical tests.
Ultimately, success depends not on the speed with which new summits are opened, but on whether it will be possible to turn scattered prototypes into a reliable instrument recognized by all — one that will genuinely reduce the number of animals in laboratories and accelerate the arrival of safe medicines.
