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Category
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2
Drug Advisory Board
This guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.
Policy framework.
Expert opinion of the European Tuberculosis Laboratory Initiative core group members for the WHO European Region.
Direct acting antivirals (DAAs) have revolutionized treatment for hepatitis C. Combi-
nations of DAAs can cure infection with HCV in 12 weeks, are highly effective and
have limited side-effects. Affordability of DAAs has improved significantly, but access remains lim-
i
...
ted. Initially, due to their high prices, affordability of DAAs was limited in high-, middle- and low-
income countries alike. Now there is a divide between those countries where, because of intellectual
property barriers, prices have remained (very) high and other countries where generics are, or can be,
available at much lower prices. The result is a dual market
more
Policy statement.
The current document provides the background, justification and objectives for the revision of WHO policy on LF-LAM. It provides details on the index test (AlereLAM) being assessed. It also describes the process of evidence retrieval, quality assessment and grading; formulation of the recommendation
...
s; and GDG decision-making. Finally, the document presents policy recommendations and related remarks.
more
Document No. : FDA/SMC/SMD/GL-SMP/2015/05 |
These guidelines are for information, guidance and strict compliance by Marketing Authorization Holders and Local Representatives of regulated products to help in the continuous safety monitoring of products granted marketing authorization in Ghana.
Document No. : FDA/SMC/SMD/GL-RAR/2013/01
These guidelines present evidence-based recommendations and best practice statements on use of medically important antimicrobials in food-producing animals, based on the WHO list of critically important antimicrobials for human medicine (WHO CIA List). These guidelines aim primarily to help preserve
...
the effectiveness of medically important antimicrobials, particularly those antimicrobials judged to be critically important to human medicine and also help preserve the effectiveness of antimicrobials for veterinary medicine, in direct support of the WHO global action plan on antimicrobial resistance
more