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Table 2 Timeline of correspondence milestones

From: Open data 5 years on: a case series of 12 freedom of information requests for regulatory data to the European Medicines Agency

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
  1. arelease still ongoing at cutoff date; bmay include items expected but not received as of cutoff date
  2. 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