OBJECTIVES: Early Market Access Pathways (EMAPs) have evolved rapidly over the recent years.  This research aims to provide an update on the Early Market Access Pathways (EMAPs) in Europe/Japan, and to understand their impact on P&R for such products. METHODS: EMA and market-specific websites were assessed for updates on the EMAPs. Reports from HTA bodies were analysed to understand the reimbursement decisions. Payers (2-3 per market in France, Germany, UK and Japan) were interviewed to validate/substantiate the findings from secondary research.  RESULTS: In Europe, while conditional market authorization (CMA) from EMA provides early access for patients to new medicines, the downstream HTA assessment process at the country level has remained relatively unchanged. Products that received CMA from EMA were frequently rejected by NICE and SMC in the UK for reimbursement due to lack of data on cost-effectiveness. In Germany, the CMA products with orphan status were reimbursed since benefit is assumed under AMNOG; however, CMA products without orphan status were not reccomended due to less robust trial design and immature data. In France, the CMA products often received low ASMR rating. Market-specific EMAPs, such as ATU in France and EAMS in the UK, offer additional routes. Some payers regard these more highly than the EMA/CMA, since these schemes recognise a products innovative nature. In Japan, the Pharmaceuticals and Medical Devices Act was introduced in 2013 to allow early access for regenerative/cell/gene medicine products. Two products have gone through the process, and one of them (Temcell) received full approval and reimbursement in Nov 2015.  CONCLUSIONS: While the EMAPs provides routes of early access for patients to new medicines, limited data increases the uncertainty/risk for the payers. Such uncertainties will need to be addressed to gain payer endorsement and ensure true early market access through mechanisms such as innovative pricing schemes and managed entry agreements.