Data collected is for drugs launched from 2020 to 2023. In most countries, availability equates to granting of access to the reimbursement list, except in DK, FI, NO, SE some hospital products are not covered by the general reimbursement scheme. The time to availability (formerly known as length of delay) is the days between EMA marketing authorization and the date of availability to patients.Â
* These countries did not complete a full dataset and therefore availability may be unrepresentative. ** The source mentions that it does not consider France's system of temporary authorization for some products, which means this time will be higher than in reality. *** MHRA’s Early Access to Medicines Scheme provides access before marketing authorization but is not included within this analysis, and would reduce the overall days for a small subset of medicines.
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Time between non-oncology orphan drugs approval and patient access in Europe 2025
This statistic displays the average time of non-oncology orphan medicines gaining marketing authorization and patient access in European countries as of January 5, 2025. According to the data, Germany had an average time of *** days between authorization and access for non-oncology orphan medicines (for drugs launched from 2020 to 2023), compared to around *** days in Portugal.
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IQVIA, & EFPIA. (May 26, 2025). Average time between marketing approval and patient access for non-oncology orphan drugs in Europe as of 2025, by country (in days) [Graph]. In ÌÇÐÄÆƽâ°æ. Retrieved July 28, 2026, from /statistics/1248715/europe-time-between-non-oncology-orphan-drugs-authorization-and-access/
IQVIA, und EFPIA. "Average time between marketing approval and patient access for non-oncology orphan drugs in Europe as of 2025, by country (in days)." Chart. May 26, 2025. ÌÇÐÄÆƽâ°æ. Accessed July 28, 2026. /statistics/1248715/europe-time-between-non-oncology-orphan-drugs-authorization-and-access/
IQVIA, EFPIA. (2025). Average time between marketing approval and patient access for non-oncology orphan drugs in Europe as of 2025, by country (in days). ÌÇÐÄÆƽâ°æ. ÌÇÐÄÆƽâ°æ Inc.. Accessed: July 28, 2026. /statistics/1248715/europe-time-between-non-oncology-orphan-drugs-authorization-and-access/
IQVIA, and EFPIA. "Average Time between Marketing Approval and Patient Access for Non-oncology Orphan Drugs in Europe as of 2025, by Country (in Days)." ÌÇÐÄÆƽâ°æ, ÌÇÐÄÆƽâ°æ Inc., 26 May 2025, /statistics/1248715/europe-time-between-non-oncology-orphan-drugs-authorization-and-access/
IQVIA & EFPIA, Average time between marketing approval and patient access for non-oncology orphan drugs in Europe as of 2025, by country (in days) ÌÇÐÄÆƽâ°æ, /statistics/1248715/europe-time-between-non-oncology-orphan-drugs-authorization-and-access/ (last visited July 28, 2026)
Average time between marketing approval and patient access for non-oncology orphan drugs in Europe as of 2025, by country (in days) [Graph], IQVIA, & EFPIA, May 26, 2025. [Online]. Available: /statistics/1248715/europe-time-between-non-oncology-orphan-drugs-authorization-and-access/
