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 |