This guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.
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
MMWR. Recommendations and Reports:
December 16, 2005 / 54(RR15);49-55
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention.
Division of Tuberculosis Elimination.
Application of a One Health approach .
The present guidance was developed with the support of the WHO Advisory Group on Integrated Surveillance of Antimicrobial Resistance (AGISAR) to assist countries and other stakeholders in the establishment and development of programmes of integrated surveillan...ce of antimicrobial resistance in the foodborne bacteria (i.e., bacteria commonly transmitted by food) by taking a One Health approach.
more
Made under Section 5 (c) of the Tanzania Food, Drugs and Cosmetics Act, 2003 | Second Edition