Review of biosimilar regulatory guidelines and scientific principles:Experiences from Europe-an Medicines Agency (EMA) guidelines / 中国卫生政策研究
Chinese Journal of Health Policy
;
(12): 21-26, 2014.
Artigo
em Chinês
| WPRIM
| ID: wpr-459857
ABSTRACT
In this study, a literature review was adopted to specify terminology of biosimilars and demonstrate the basic characteristic of biologics and relevant research and development ( R&D) procedures. The regulatory frame-work of the European Medicines Agency ( EMA ) guidelines on biosimilars was introduced. Explicitly, regulatory guidelines and scientific principles, regarding biosimilarity, safety and immunogenicity, extrapolation, labels and names, data protection, were systematically introduced, as well as interchangeability and pharmacovigilance, respec-tively. The purpose of the study is to provide regulatory references for Chinese legislators and recommendations on the R&D of biosimilars in the biopharmaceutical industry.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Tipo de estudo:
Guia de Prática Clínica
Idioma:
Chinês
Revista:
Chinese Journal of Health Policy
Ano de publicação:
2014
Tipo de documento:
Artigo
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