Table 1. Expedited pathways for early EMA marketing approval [3–6].

	CMA	AA
Introduced	2006	2004
Purpose	Earlier authorisation of products for patients with unmet medical needs on the basis of less complete clinical data	Reduction of assessment time for marketing authorisation applications to 150 days or less (compared with standard 210 days)
Eligibility Criteria	Products for which the benefit-risk balance is such that expedited access offsets the limitations of an incomplete data set, i.e., products that potentially address an ‘unmet medical need’	Products of major interest from a public health perspective—typically, that the products address, to a significant extent, the unmet medical needs that maintain/improve the health of society, i.e., introducing new methods of therapy or improving existing ones
Evidence Requirements	Safety and efficacy evidence profile incomplete at time of authorisation	Full safety and efficacy evidence profile available at time of authorisation
Postmarketing Requirements	Authorisations are subject to specific obligations	Obligations may apply
Specific Obligations	Yes—ensure comprehensive evidence is generated after authorisation within an agreed time frame	No

Abbreviations: AA, accelerated assessment; CMA, conditional marketing authorisation; EMA, European Medicines Agency.