Transparency in drug regulation: public assessment reports in Europe and Australia.
Drug Discov Today
; 21(11): 1806-1813, 2016 11.
Article
em En
| MEDLINE
| ID: mdl-27373773
ABSTRACT
Openness and transparency are important considerations for medicines regulators, where public health is of paramount concern. As part of their commitment to transparency, the European Medicines Agency (EMA) and Therapeutic Goods Administration (TGA) in Australia publish information relating to their evaluation of medicines via public assessment reports. European Public Assessment Reports (EPARs) and Australian Public Assessment Reports (AusPARs) provide information about the considerations that led the regulator to approve or refuse the application. The reports summarise assessments by each regulator of the information provided on the quality, safety, and efficacy of the medicine under evaluation. Here, we describe the experiences of two established medicines regulators in publishing public assessment reports, and reflect on their future role in communicating medicines information.
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1
Base de dados:
MEDLINE
Assunto principal:
Participação da Comunidade
/
Controle de Medicamentos e Entorpecentes
Idioma:
En
Ano de publicação:
2016
Tipo de documento:
Article