Statistics
Clinical Trials
Applications pursuant to EU Regulation 536/2014
With the entry into force of EU Regulation 536/2014 on 31 January 2022, the submission, evaluation and monitoring procedures for clinical trials in the EU were standardised via the Clinical Trials Information System (CTIS).
The following table lists the number of applications for clinical trial authorisation submitted to the BfArM.
| Year | Phase I | Phase I + II | Phase II | Phase II + III | Phase III | Phase III + IV | Phase IV | Total applications |
|---|---|---|---|---|---|---|---|---|
| 2023 | 85 | 24 | 102 | 13 | 181 | 5 | 16 | 426 |
| 2024 | 117 | 22 | 126 | 15 | 187 | 2 | 18 | 487 |
Applications for clinical trials of medicinal products Transition trials
Clinical trials authorised under Directive 2001/20/EU may only continue after 30 January 2025 if they have also been transferred to Regulation (EU) 536/2014 by that date.
| Year | Phase I | Phase I + II | Phase II | Phase II + III | Phase III | Phase III + IV | Phase IV | Total applications |
|---|---|---|---|---|---|---|---|---|
| 2023 | 9 | 7 | 26 | 5 | 70 | 2 | 3 | 122 |
Applications under Directive 2001/20/EC
Until the deadline for the transition period from Directive 2001/20/EC to EU Regulation 536/2014 on 31 January 2023, initial clinical trials could be conducted in accordance with either of the two legal bases. Trial phases may overlap, lower annual totals may result.
| Year | Phase I | Phase II | Phase III | Phase IV | Total applications |
|---|---|---|---|---|---|
| Januar 2023 | 31 | 36 | 28 | 2 | 84 |
Clinial Trials 2016-2022
Trial phases may overlap, lower annual totals may result.
| Year | Phase I | Phase II | Phase III | Phase IV | Total applications |
|---|---|---|---|---|---|
| 2016 | 207 | 226 | 243 | 39 | 771 |
| 2017 | 203 | 233 | 234 | 38 | 683 |
| 2018 | 171 | 220 | 263 | 40 | 650 |
| 2019 | 195 | 247 | 219 | 24 | 649 |
| 2020 | 167 | 225 | 220 | 26 | 593 |
| 2021 | 168 | 225 | 243 | 25 | 603 |
| 2022 | 156 | 188 | 169 | 21 | 534 |