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Regulatory requirements for the registration of generic medicines and format of drug dossiers: procedures in Sri Lanka in comparison with selected regulatory authorities

BACKGROUND: The regulatory requirements for approval of generic medicines and the format of compiling drug dossiers vary among regulatory authorities. The variation is particularly wide between High-income countries (HIC) and lower and middle-income countries (LMIC) with different regulatory framewo...

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Detalles Bibliográficos
Autores principales:	Thambavita, D., Galappatthy, P., Jayakody, R. L.
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BioMed Central 2018
Materias:	Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6011264/ https://www.ncbi.nlm.nih.gov/pubmed/29951208 http://dx.doi.org/10.1186/s40545-018-0141-2

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