Critical review on the Environmental Risk Assessment of medicinal products for human use in the centralised procedure.
In this article we analyse the Environmental Risk Assessment (ERA) of 59 medicinal products for human use authorised in the EU through the centralised procedure between 2011 and 2012, to establish whether company submissions are compliant with the European Medicines Agency (EMA) guideline and complete in terms of data and study reports provided. The most frequent questions raised by EU regulatory authorities are described, together with an evaluation of the presence and quality of ERA-related information in published regulatory assessment documents. The results of this review show recent improvement in ERA-related data presented in regulatory assessment documents available to the public while also highlighting a need to develop further guidance on environmental issues in order to assist applicants improve their ERA dossiers and overcome current shortcomings.
European Medicines Agency, Specialised Scientific Disciplines Department, 7 Westferry Circus, Canary Wharf, London E14 4HB, United Kingdom.
Laura
L
Caneva
European Medicines Agency, Specialised Scientific Disciplines Department, 7 Westferry Circus, Canary Wharf, London E14 4HB, United Kingdom. Electronic address: Milton.Bonelli@ema.europa.eu.
Milton
M
Bonelli
European Medicines Agency, Specialised Scientific Disciplines Department, 7 Westferry Circus, Canary Wharf, London E14 4HB, United Kingdom.
Marisa
M
Papaluca-Amati
European Medicines Agency, Specialised Scientific Disciplines Department, 7 Westferry Circus, Canary Wharf, London E14 4HB, United Kingdom.
Jean-Marc
JM
Vidal
D017277:Drug Approval; D004777:Environment; D005062:European Union; D006801:Humans; D004364:Pharmaceutical Preparations; D018570:Risk Assessment
D004364:Pharmaceutical Preparations
EPAR; ERA; European Medicines Agency; Marketing authorisation; Risk assessment