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2
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
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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.
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
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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.
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Lancet Planet Health 2017 Published Online November 6, 2017 http://dx.doi.org/10.1016/S2542-5196(17)30141-9
Doc. No.: INS/GDL/001-(Annexes)
Medicines and Allied Substances [No. 3 of 2013 47 | An Act to continue the existence of the Pharmaceutical Regulatory Authority and re-name it as the Zambia Medicines Regulatory Authority; provide for the functions and powers of the Authority; provide for the registration and regulation of pharmacie
...
s, health shops and agro-veterinary shops; provide for the registration and regulation of medicines and allied substances; provide for the regulation of the manufacture, importation, exportation, possession, storage, distribution, supply, promotion, advertising, sale and use of medicines and allied substances; provide for the regulation and control of clinical trials; repeal and replace the Pharmaceutical Act, 2004; and provide for matters connected with, or incidental to, the foregoing.
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Guidance for the preparation and submission of dossiers
An Act to provide for the efficient and comprehensive regulation and control of food, drugs, medical devices, cosmetics, herbal drugs and poisons and to repeal the Food
(Control of Quality) Act, 1978, the Pharmaceuticals and Poisons Act, 1978 and to provide for related matters.