OBJECTIVES: This study intends to provide an overview of regulatory updates on Early Access Programmes (EAPs) in 21 countries and score the drivers of successful implementation by examining the national regulatory framework, process, requirements, and revenue opportunity. METHODS: A literature review was conducted from government and health authority websites, Pubmed, and grey literature to identify EAP regulation, practice, and updates. We inputted information in an Excel template and aggregated it with 3 indicators (clarity of the process, ease of implementation, and revenue possibility). The 3 indicators were ranked from 1 (least feasible, multiple barriers) to 4 (most feasible, least barriers). Geographical scope covered: France, Germany, Italy, Spain, UK, Austria, Belgium, Denmark, Norway, Poland, Portugal, Sweden, Switzerland, Australia, Brazil, Canada, Israel, New Zealand, South Africa, South Korea, and Turkey. RESULTS: Regulatory updates were found in the countries with variable magnitude. Scores as follows: ++++: France; +++: Spain, Italy, Austria, Denmark, Norway, Canada, Israel, Australia, and New Zealand; ++: Germany, Portugal, Sweden-CUP, Switzerland, Brazil, South Africa, South Korea, Turkey; and +: UK, Belgium, and Poland. France, a pioneer in EAPs, scored highest. +++ countries have clear processes, free pricing, and possible reimbursement. In ++ countries, EAP sales are not possible. For UK and Belgium, processes are relatively new (2014) with steep fees, and are yet to be validated. Sales are not possible in the UK and details for Belgium are still unavailable. CONCLUSIONS: EAP policies are evolving fast, signaling high interest, and will likely be increasingly important. Regulatory changes tend to ease and expedite the EAP process but fees are being imposed and sales limited in newer regulations. It is yet to be seen how updates will affect the market access condition of products undergoing EAP. Companies must be abreast with changes to capitalise on early access opportunities and mitigate risks.