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Publication Years
3042
6217
936
45
2
1
Category
3973
714
699
557
540
225
106
3
Toolboxes
878
723
486
485
391
372
351
314
294
288
277
202
194
193
174
167
163
146
130
109
86
78
73
53
35
11
2
This guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.
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
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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.
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Document No. : FDA/SMC/CTD/GL-CCT/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
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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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PMPB/INS-GUIDE/04
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.
more
Guidance for the preparation and submission of dossiers
