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 framewor...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
| Published: |
Taylor & Francis Group
2018-12-01
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| Series: | Journal of Pharmaceutical Policy and Practice |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1186/s40545-018-0141-2 |