| Year | 2021 | 2022 |
|---|---|---|
| Total | 155 | 104 |
| Year | 2021 | 2022 |
|---|---|---|
| Total | 21 | 16 |
| Rapporteur or Co-Rapporteur | 8 | 11 |
| Concerned Member State and Peer Reviewer | 13 | 5 |
| Year | 2021 | 2022 |
|---|---|---|
| Total | 41 | 12 |
| Reference Member State (RMS) | 15 | 8 |
| Concernded Member State (CMS) | 26 | 4 |
| Year | 2021 | 2022 |
|---|---|---|
| Total | 87 | 73 |
| Original Manufacturer | 43 | 50 |
| Parallel Imports | 44 | 23 |
| Year | 2021 | 2022 |
|---|---|---|
| Total | 6 | 3 |
| ATMPs pursuant § 4b Medicinal Products Act | 2 | 0 |
| Tissue preparations pursuant § 21a Medicinal Products Act | 4 | 3 |
| Year | 2021 | 2022 |
|---|---|---|
| Total | 920 | 943 |
| Year | 2021 | 2022 |
|---|---|---|
| Total | 418 | 395 |
| Renewal | 21 | 16 |
| Type Ib-Variations incl. Grouping | 141 | 128 |
| Type II-Variations incl. Grouping, Worksharing | 138 | 124 |
| Post-authorisation measures | 118 | 127 |
| Year | 2021 | 2022 |
|---|---|---|
| Total | 217 | 190 |
| Renewal | 19 | 13 |
| Type II-Variations incl. Grouping, Worksharing | 198 | 177 |
| Year | 2021 | 2022 |
|---|---|---|
| Total | 285 | 358 |
| Renewal | 92 | 118 |
| Notifications of variations which require approval/Type II variations incl. Grouping, Worksharing | 193 | 240 |
| Year | 2021 | 2022 |
|---|---|---|
| Total | 228 | 49 |
| Year | 2021 | 2022 |
|---|---|---|
| Total | 88 | 37 |
| Rapporteur | 41 | 20 |
| Peer Reviewer | 47 | 17 |
| Year | 2021 | 2022 |
|---|---|---|
| Total | 20 | 12 |
| Co-ordination | 13 | 6 |
| Peer Reviewer | 7 | 6 |
| Year | 2021 | 2022 |
|---|---|---|
| Total | 15,743 | 18,997 |
| Year | 2021 | 2022 |
|---|---|---|
| Total | 13,791 | 16,563 |
| Batch release based on experimental testing | 4,667 | 5,217 |
| Batch release based on the review of batch control documents, recognition of batch tests by EU/EEA member states | 9,124 | 11,346 |
| Year | 2021 | 2022 |
|---|---|---|
| Total | 1,952 | 2,434 |
| Certificates of Plasma Origin | 1,742 | 2,232 |
| Plasma Pool Certificates | 79 | 69 |
| Plasma Pool Tests for third parties | 131 | 133 |
| Year | 2021 | 2022 |
|---|---|---|
| Total | 1,105 | 1,187 |
| Assessment and decision on applications for the approval of clinical trials of medicinal products for human use | 390 | 416 |
| Submission of Annual Safety Reports (ASR) for clinical trials | 715 | 771 |
| Year | 2021 | 2022 |
|---|---|---|
| Total | 304 | 278 |
| National scientific advice | 224 | 211 |
| European scientific advice/protocol assistence by the EMA: PEI as co-ordinator and responsible for answering questions | 73 | 62 |
| Binational scientific advice | 7 | 5 |
| Year | 2021 | 2022 |
|---|---|---|
| Total (without ADRs) | 735 | 456 |
| Year | 2021 | 2022 |
|---|---|---|
| Total | 220 | 188 |
| Periodic Safety Update Single Assessments (PSUSAs) | 62 | 51 |
| PSURs for biomedicines authorised in the centralised procedure | 96 | 81 |
| PSURs for biomedicines authorised in the mutual recongnition procedure | 2 | 0 |
| PSURs for nationally authorised biomedicines | 60 | 56 |
| Year | 2021 | 2022 |
|---|---|---|
| Total | 515 | 268 |
| Development Safety Update Reports (DSUR) | 202 | 87 |
| Risk-Management-Plans (RMP) | 217 | 106 |
| PhV System Assessment | 44 | 16 |
| Post Authorisation Measure (PAM) | 41 | 49 |
| Post-Authorisation-Safety-Studies (PASS) | 11 | 10 |
| Year | 2021 | 2022 |
|---|---|---|
| Adverse Drug Reactions (ADRs) | 259,132 | 203,036 |
| Year | 2021 | 2022 |
|---|---|---|
| Total | 167 | 220 |
| Year | 2021 | 2022 |
|---|---|---|
| Total | 45 | 63 |
| Good Clinical Practice (GCP) Inspections (lead and/or reporting inspector) | 5 | 15 |
| Good Manufacturing Practice (GMP) Inspections (lead and/or reporting inspector) | 0 | 1 |
| Inspections (lead and/or reporting inspector) | 40 | 47 |
| Year | 2021 | 2022 |
|---|---|---|
| Total | 112 | 150 |
| Manufacturing authorisation and authorisation for the procurement of tissues, for the processing of tissue or tissue preparations | 15 | 21 |
| Import authorisations and certificates for medicinal procucts, active substances, for tissues and specific tissue preperations | 0 | 9 |
| Routine inspections | 97 | 120 |
| Year | 2021 | 2022 |
|---|---|---|
| Total | 10 | 7 |
| Pharmacovigilance inspections | 10 | 7 |