Critical review on the Environmental Risk Assessment of medicinal products for human use in the centralised procedure.
Regul Toxicol Pharmacol
; 68(3): 312-6, 2014 Apr.
Article
in En
| MEDLINE
| ID: mdl-24447908
ABSTRACT
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.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Pharmaceutical Preparations
/
Environment
Type of study:
Etiology_studies
/
Risk_factors_studies
Limits:
Humans
Language:
En
Journal:
Regul Toxicol Pharmacol
Year:
2014
Document type:
Article
Affiliation country:
United kingdom