Table 2.
Timeline of correspondence milestones
| Request no. | Documents receivedb | Time to initial decision, weeks | Time to final decision (if appeal lodged), weeks | Time to initial receipt of data, weeks | Time to final receipt of data, weeks |
|---|---|---|---|---|---|
| 1 | 16 CSRs | 2 | N/A | 9 | 17 |
| 2 | 4 CSRs, regulatory comments, decision records, other material such as slides, correspondence, records of meetings, follow-up material | 4 | N/A | 22 | 186 |
| 3 | 8 CSRs | 9 | N/A | 9 | 33 |
| 4 | 38 animal study reports | 4 | N/A | 3 | 17 |
| 5 | 3 periodic safety update reports | 1 | N/A | 5 | 36 |
| 6 | Specific analysis from ICH CTD module 5 | 10 | 43 | 43 | 43 |
| 7 | Multiple sections of CSR from 97 CSRs | 13 | 22 | 58 | 112 |
| 8 | 3 CSRs | 7 | N/A | 7 | 49 |
| 9 | 3 CSRs, CHMP minutes and other CHMP documents | 11 | N/A | 16 | 49 |
| 10 | None | 3 | 7 | Appeal denied | |
| 11a | 43 CSRs for 2 vaccines and 1 antiviral | 4 | 7 | 15 | 47 |
| 12a | Postmarketing data submitted by the manufacturer | 3 | N/A | 3 | 3 |
arelease still ongoing at cutoff date; bmay include items expected but not received as of cutoff date
CHMP Committee for Medicinal Products for Human Use, CSR Clinical Study Report, CTD Common Technical Document, ICH International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, N/A not applicable