Attachment 1: Information Required by MS for Applications to a Competent Authority

Attachment 1

CTFG

28 January 2010

QUESTION : Dedicated resources for CT Safety assessment in MS in December 2010: (FTE)
MS / Number CTA (2009) / Number of SUSARs (2009) / Number of ASRs (2009) / Number of SUSARs assessors / Number of ASR assessors / Other (detailed + number)
AT / 305 / 178 / 713 / 0.1 / variable
(done by CTA assessor)
BE / 1208* / 830* / 0 / 0 / 0
BG / 191* / 243* / 0* / 0*
CY
CZ / 359 / 142 SUSAR reports, right No 49 SUSAR(only from CR) / Numbers not followed / 0,2 / 0,2 (SUSAR + ASR both)
DE (BfArM) / 1048 / 23779
(3604 occurred in MS, 20175 outside MS) / 900 / 0.33 / 0.33 / 6 data entry personal in PV department
DE (PEI) / 219 / 1130 / 247 / 0,1 / 0,4
DK / 276 / 133 national SUSARs (291 incl. follow ups) / 494 / Part-time allocation so SUSARs app. 10 h/week (incl. EVCTM)
~ 0.25 / 2 part-time medical assessors (20 h/week)
~ 0.25 / 0.5 for administrative handling
EE / 0* / 0*
ES / 4470 SUSARs including initial reports and follow-up reports / 1440 / 0.5 / 0.5 / 1 FET
FI
FR / 920 / 48000 reports (initial + follow up/ local + outside) / 1070 / 1.6 / 0.5 / 0
GR / 306* / 221* / 0 / 0 / 0
HU / 314 / 238 / 475 / 0.33 / none
IE / 99 / 44 / 144 / 0.5 / 0.5
IS / 12 / 0
IT
LT
LU
LV / 193* / 80* / 0* / 0*
MT
NL / / / / / / / / / /
NO / 0* / 0*
PL / 474* / 0* / 0*
PT / 116 / 250 / 160 / 0,1 FTE / 0,1 FTE (SUSAR + ASR done by CTA assessor )
SE / 414 / 195 / Approx. 325 unique, double amount submitted but one ASR refers to several studies / 0.20 / 1.0
SI
SK
UK / 16919* (1624 UK + 15295 foreign) / 1568* (relating to 2506 active CTs) / 1.25* / 1.25*
Total / 91 776 / 7 697 / 5.46 / 5.28 / 6.5 (data entry)

*: response in July 2010

EV-CTM statistics (cumulative) / 2009 / 2010
- Cases of SUSARs
- ICRSs (reports)
- Geographic origin : EEA/non EEA
- Who reports? / - 140150
- 339442
- 51%, 49%
- 81% reported by sponsors, 19% by NCAs
- 138 commercial sponsors, 14 non commercial sponsors, 9 NCAs / - 175559
- 439025
- 51% ; 49%
- 80%/20%