Presentation (CTI)

OBJECTIVES: To assess whether the EU Joint Clinical Assessment (JCA), mandatory since January 2025 for oncology medicines and advanced therapy medicinal products (ATMPs), would change the traditional country-entry order of global launch sequencing.
METHODS: A scoping review of scientific databases and grey literature was conducted. Relevant sources, including peer-reviewed publications, conference abstracts, and industry analyses that discussed launch sequencing and JCA market-access implications, were assessed.
RESULTS: The review yielded five industry analyses and four peer-reviewed/conference items published between February 2024 and June 2026. The identified materials anticipated the following changes: (i) JCA's shared evidence base may enable mid-sized CEE markets to move earlier in the sequence, consolidating a shift toward a near-simultaneous pan-EU launch rather than uneven waves. (ii) An alternative scenario is that demanding evidence requirements (a high number of PICOs per product) may cause small manufacturers to delay or forgo the EU launch altogether, making emerging markets (China, Brazil) more attractive as alternatives. (iii) While JCA may facilitate earlier CEE access, earlier price visibility in lower-price markets is anticipated to trigger international reference pricing cascades that erode European average list prices, inducing manufacturers to stay cautious about accelerating CEE launches. (iv) JCA runs parallel to the EMA review and does not affect marketing authorisation timing. As most in-scope products already carry prior FDA approval, the US-first global sequence is expected to persist.
CONCLUSIONS: No validated empirical evidence of the JCA impact on global launch sequencing of oncology medicines and ATMPs is available yet. All findings are anticipatory rather than empirical. Based on the sources obtained, JCA is unlikely to reorder the US-first global sequence but is expected to compress intra-EU launch waves, while CEE market standing remains constrained.