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

Internet

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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