EMA Mid-year report 2020

The European Medicines Agency (EMA) has published its mid-year report for 2020.

The report describes the results and achievements of the EMA regarding human and veterinary medicines between 01 Jan and 30 Jun 2020, working closely with national competent authorities (NCA).

Following the outbreak of the COVID-19 global pandemic, the EMA invoked its business continuity and public health threat plan in order to protect staff, delegates and contractors’ health and safety while delivering on its mandate. The crisis has changed the landscape in which the EMA operates and has affected the whole European Medicines Regulatory Network (EMRN) – EMA, NCAs and the European Commission (EC). The full impact of the pandemic on the EMA’s achievements remains to be seen.

During this six month period, requests for advanced-therapy medicinal products (ATMP) classifications doubled compared to the last three years combined (54 vs 27). Initial evaluation applications received remained. Initial evaluation applications of new non-orphan medicinal products grew over 50% compared to 2019 (28 vs 18). The number of granted requests for accelerated assessment saw a sharp increase, due to the COVID-19 pandemic, reaching a 5 year peak. Furthermore, type IB and type II variations grew almost by 30% compared to 2019. Line extensions of marketing authorisations also saw a significant increase compared to the average of the previous five years (24 vs 11). Article 61(3) applications decreased significantly as a result of a drop in the submissions during the first half of 2020.

Inspections and compliance were greatly affected by the pandemic. Good manufacturing practice (GMP), good clinical practice (GCP) and Plasma Master File (PMF) inspections notably decreased due to the travel restrictions related to the COVID-19 pandemic. Standard certificate requests significantly increased compared to the first half of 2019 (1538 vs 1284), whereas urgent certificate requests saw a major drop (729 vs 1349). 97% of standard certificates were issued within the set timelines, with the average time to issue standard certificates was 26 days, showing great improvement in performance from previous years.

Furthermore, there was a large variation in number of meetings due to the pandemic. As expected, the number of physical meetings dropped and there was a spike of the number of virtual meetings (2,660 vs 1,659 in 2019). Consequently, the number of reimbursed and non-reimbursed delegates sharply fell.

Take a look at the full report here.