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

Table 1 Table of 12 included requests in chronological order

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 antibiotics^a	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
11	28 May 2014	1 antiviral: sofosbuvir	43 CSRs
12	8 May 2015	1 volume expander: hydroxyethyl starch	Postmarketing data submitted by the manufacturer

^aAltargo, Cayston, Colobreathe, Cubicin, Dificlif, Doribax, Invanz, Ketek, Levviax, Tobi Podhaler, Trovan, Trovan IV, Truvel, Truvel IV, Tygacil, Vibativ, Zinforo
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

ISSN: 1745-6215