Can Asian-Dominant Evidence Support an EU Marketing Authorisation?

An increasing number of novel molecular entities and biosimilars reach the European Medicines Agency (EMA) supported by pivotal evidence derived predominantly from Asian patient populations – a pattern the existing ICH E5 framework was not originally designed to address. For pharmaceutical companies based in Asia looking to expand into Europe, understanding how the EMA actually assesses this kind of evidence, rather than assuming it, is becoming a critical part of regulatory strategy. 

That is the question addressed by the tenth regulatory science publication from Zwiers Regulatory Company – a ProductLife Group company – published in Clinical and Translational Science. 

“Translating Asian-Dominant Pivotal Evidence into EU Marketing Authorisation: An EMA Regulatory Document Analysis, 2021–2025” (by Prerona Boruah & Alex Zwiers) reviews ten EMA applications assessed between 2021 and 2025 that relied predominantly on Asian pivotal evidence. Eight of the ten were authorised and two were withdrawn; most concentrated in oncology, particularly PD-1/PD-L1 monoclonal antibodies. 

Across these cases, EMA’s assessment consistently turned on four factors: expected intrinsic ethnic sensitivity of the product, adequacy of the bridging evidence, any GCP or manufacturing findings, and – the least standardised of the four – how comparable clinical practice in the originating country was to the EU standard of care. 

The study’s conclusion is a concrete one: Asian-dominant evidence can support a successful EU authorisation – but transparent assessment of extrinsic practice differences, addressed from the outset of the development strategy, is essential for reliable translation of that evidence. 

This is the tenth paper in an ongoing regulatory science research effort that began in 2021 – read more about the full body of work and what it represents for the network.