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

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

Abstract 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...

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Bibliographic Details
Main Authors: D. Thambavita, P. Galappatthy, R. L. Jayakody
Format: Article
Language:English
Published: BMC 2018-06-01
Series:Journal of Pharmaceutical Policy and Practice
Subjects:
Dossier
Generic drugs
Bioequivalence
Biowaiver
DRA process
Online Access:http://link.springer.com/article/10.1186/s40545-018-0141-2

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http://link.springer.com/article/10.1186/s40545-018-0141-2

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