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Table 1 Table of 12 included requests in chronological order

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. Date of request Compounds Documents requested
1 25 Jan 2011 1 antiviral: oseltamivir 31 CSRs
2 29 Oct 2011 2 vaccines: Pandemrix and Focetria 4 CSRs, regulatory comments, decision records, other material such as slides, correspondence, records of meetings, follow-up material
3 22 Dec 2011 1 antipsychotic: aripiprazole 3 CSRs
1 statin: atorvastatin
1 antidiabetic: pioglitazone
4 11 Sep 2012 1 antiviral: oseltamivir 38 animal study reports
5 23 Oct 2012 1 antiviral: oseltamivir 3 periodic safety update reports
6 2 Dec 2012 1 antiviral: oseltamivir Specific analysis from ICH CTD module 5
7 25 Feb 2013 17 antibioticsa Multiple sections of CSR from 97 CSRs
8 4 Apr 2014 1 anti-inflammatory: adalimumab 3 CSRs
9 16 Apr 2014 1 antibiotic: bedaquiline 3 CSRs, CHMP minutes and other CHMP documents
10 16 Apr 2014 48 medicines [21] Infringement procedure documents
11 28 May 2014 2 vaccines: Gardasil and Cervarix 43 CSRs
1 antiviral: sofosbuvir
12 8 May 2015 1 volume expander: hydroxyethyl starch Postmarketing data submitted by the manufacturer
  1. aAltargo, Cayston, Colobreathe, Cubicin, Dificlif, Doribax, Invanz, Ketek, Levviax, Tobi Podhaler, Trovan, Trovan IV, Truvel, Truvel IV, Tygacil, Vibativ, Zinforo
  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