Regulatory requirements for the registration of generic medicines and format of drug dossiers: procedures in Sri Lanka in comparison with selected regulatory authorities
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DOI: 10.1186/s40545-018-0141-2
Abstract: BackgroundThe 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… read more here.
Keywords: sri lanka; drug; drug dossiers; generic medicines ... See more keywords