209 marketing authorisation procedures were completed by the Paul-Ehrlich-Institut in 2019/20.
All Procedures| Year | 2019 | 2020 |
|---|
| Total | 90 | 119 |
Centralised European Procedures| Year | 2019 | 2020 |
|---|
| Total | 23 | 42 |
| Rapporteur or Co-Rapporteur | 7 | 11 |
| Concerned Member State and Peer Reviewer | 16 | 31 |
Mutual Recognition (MR) and Decentralised Procedures (DCP)| Year | 2019 | 2020 |
|---|
| Total | 22 | 26 |
| Reference Member State (RMS) | 12 | 10 |
| Concernded Member State (CMS) | 10 | 16 |
National Procedure| Year | 2019 | 2020 |
|---|
| Total | 37 | 45 |
| Original Manufacturer | 24 | 24 |
| Parallel Imports | 13 | 21 |
Approval of Tissue Preparations and Advanced Therapy Medicinal Products (ATMP)| Year | 2019 | 2020 |
|---|
| Total | 8 | 6 |
| ATMPs pursuant § 4b Medicinal Products Act | 1 | 0 |
| Tissue preparations pursuant § 21a Medicinal Products Act | 7 | 6 |
1,489 subsequent procedures after marketing authorisation were assessed by the Paul-Ehrlich-Institut in 2019/20.
All subsequent Procedures| Year | 2019 | 2020 |
|---|
| Total | 706 | 783 |
Rapporteur or Co-Rapporteur for Centralised Procedures| Year | 2019 | 2020 |
|---|
| Total | 247 | 330 |
| Extension | 4 | 6 |
| Renewal | 22 | 16 |
| Type II-Variations incl. Grouping, Worksharing | 82 | 115 |
| Worksharing of Variations | 37 | 63 |
| Post authorisation measures | 102 | 130 |
Rapporteur or recognising Agency in MR or DC Procedures| Year | 2019 | 2020 |
|---|
| Total | 192 | 209 |
| Renewal | 12 | 29 |
| Type II-Variations incl. Grouping, Worksharing | 125 | 92 |
| Worksharing of Variations | 55 | 88 |
National subsequent Procedures| Year | 2019 | 2020 |
|---|
| Total | 267 | 244 |
| Renewal | 27 | 30 |
| Notifications of variations which require approval/Type II variations incl. Grouping, Worksharing | 240 | 214 |
93 PIPs und PMFs were assessed by the Paul-Ehrlich-Institut in 2019/20.
All Assessments| Year | 2019 | 2020 |
|---|
| Total | 53 | 40 |
Assessment of Paediatric Investigation Plans (PIPs)| Year | 2019 | 2020 |
|---|
| Total | 47 | 34 |
| Rapporteur | 32 | 20 |
| Peer Reviewer | 10 | 14 |
| Concernd Member State (CMS) | 5 | 0 |
Assessment and annual Reassessment in Connection with the (Re-)certification of Plasma Master Files (PMFs)| Year | 2019 | 2020 |
|---|
| Total | 6 | 6 |
| Co-ordination | 3 | 6 |
| Peer Reviewer | 3 | 0 |
32,254 batches were released by the Paul-Ehrlich-Institut in 2019/20.
Testing| Year | 2019 | 2020 |
|---|
| Total | 16,145 | 16,109 |
Batch Release| Year | 2019 | 2020 |
|---|
| Total | 13,089 | 13,654 |
| Batch release based on experimental testing | 4,314 | 4,217 |
| Batch release based on tests performed by other EU/EEA member states or review of batch controll documents | 8,775 | 9,437 |
Blood Plasma Testing and Certification| Year | 2019 | 2020 |
|---|
| Total | 3,056 | 2,455 |
| Certificates of Plasma Origin | 88 | 111 |
| Plasma Pool Certificates | 2,826 | 2,207 |
| Plasma Pool Tests for third parties | 142 | 137 |
723 clinical trials were assessed by the Paul-Ehrlich-Institut in 2019/20.
Clinical Trials| Year | 2019 | 2020 |
|---|
| Total | 914 | 1030 |
| Assessment and decision on applications for the approval of clinical trials of medicinal products | 317 | 406 |
| Thereof Voluntary Harmonisation Procedures (VHP) | 54 | 64 |
| Submission of Annual Safety Reports (ASR) for clinical trials | 597 | 624 |
1,017 instances of scientific advice were provided by the Paul-Ehrlich-Institut in 2019/20.
Scientific Advice| Year | 2019 | 2020 |
|---|
| Total | 476 | 541 |
| National scientific advice | 244 | 236 |
| European scientific advice/protocol assistence by the EMA: PEI as co-ordinator and responsible for answering questions | 78 | 87 |
| Scientific advice coordinated by the Innovation Office | 154 | 197 |
| Binational scientific advice | 0 | 21 |
3,828 pharmacovigilance reports and signals were assessed by the Paul-Ehrlich-Institut in 2019/20.
All Reports | Year | 2019 | 2020 |
|---|
| Total (without ADRs) | 2,533 | 1,295 |
Periodic Safety Update Single Assessments and Reports (PSUSA/PSUR), Periodic Benefit-Risk Evaluation Report (PBRER)| Year | 2019 | 2020 |
|---|
| Total | 675 | 450 |
| Periodic Safety Update Single Assessments (PSUSAs) | 92 | 69 |
| PSURs/PBRERs for biomedicines authorised in the centralised procedure | 223 | 227 |
| PSURs/PBRERs for biomedicines authorised in the mutual recongnition procedure | 108 | 73 |
| PSURs/PBRERs for nationally authorised biomedicines | 252 | 81 |
Further Pharmacovigilance Assessments | Year | 2019 | 2020 |
|---|
| Total | 1,858 | 845 |
| Development Safety Update Reports (DSUR) | 372 | 198 |
| Signal evaluation procedure | 1,120 | 387 |
| Risk-Management-Plans (RMP) | 242 | 142 |
| PhV system assessment | 55 | 58 |
| Post Authorisation Measure (PAM) | 33 | 41 |
| Post-Authorisation-Safety-Studies (PASS) | 36 | 19 |
Recording and Risk Assessment of Adverse Drug reactions (ADRs)| Year | 2019 | 2020 |
|---|
| Adverse Drug Reactions (ADRs) | 14,216 | 23,731 |
406 inspections were conducted by the Paul-Ehrlich-Institut in 2019/20.
All Inspections| Year | 2019 | 2020 |
|---|
| Total | 248 | 158 |
Inspections on behalf of the European Medicines Agency (EMA)| Year | 2019 | 2020 |
|---|
| Total | 82 | 62 |
| Good Clinical Practice (GCP) Inspections (lead and/or reporting inspector, including "rolling" reviews in 2020) | 29 | 15 |
| Good Manufacturing Practice (GMP) Inspections (lead and/or reporting inspector) | 1 | 1 |
| Inspections (lead and/or reporting inspector including desk audits in 2020) | 48 | 46 |
| Pharmacovigilance Inspections (lead and/or reporting inspector) | 4 | 0 |
Participation as an Expert in National Inspections by the Competent Authorities| Year | 2019 | 2020 |
|---|
| Total | 150 | 85 |
| Manufacturing authorisation and authorisation for the procurement of tissues, for the processing of tissue or tissue preparations | 16 | 14 |
| Import authorisations and certificates for medicinal procucts, active substances, for tissues and specific tissue preperations | 19 | 0 |
| Routine inspections | 115 | 71 |
National Inspections: Lead by Paul-Ehrlich-Institut| Year | 2019 | 2020 |
|---|
| Total | 16 | 11 |
| Approval of clinical trials | 0 | 0 |
| Marketing authorisation-related inspections | 0 | 0 |
| Pharmacovigilance inspections | 16 | 11 |
