WHO Technical Report Series, No. 981 - World Health Organization
WHO Technical Report Series, No. 981 - World Health Organization
WHO Technical Report Series, No. 981 - World Health Organization
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<strong>WHO</strong> Expert Committee on Specifications for Pharmaceutical Preparations Forty-seventh report<br />
early 2012, the Committee encouraged further collaboration between the world's<br />
pharmacopoeias leading to harmonization of their work.<br />
A full list of the decisions and recommendations made by the Expert<br />
Committee at its forty-seventh meeting is given below.<br />
The following new guidelines were adopted and recommended for use:<br />
■■<br />
Release procedure for International Chemical Reference Substances<br />
(Annex 1)<br />
■■<br />
<strong>WHO</strong> guidelines on quality risk management (Annex 2)<br />
■■<br />
<strong>WHO</strong> guidelines on variations to a prequalified product (Annex 3)<br />
■■<br />
Collaborative procedure between the <strong>World</strong> <strong>Health</strong> <strong>Organization</strong><br />
Prequalification of Medicines Programme and national medicines<br />
regulatory authorities in the assessment and accelerated national<br />
registration of <strong>WHO</strong>-prequalified pharmaceutical products<br />
(Annex 4)<br />
For inclusion in The International Pharmacopoeia<br />
The following monographs were adopted:<br />
■■<br />
for antiretroviral medicines<br />
<strong>WHO</strong> <strong>Technical</strong> <strong>Report</strong> <strong>Series</strong>, <strong>No</strong>. <strong>981</strong>, 2013<br />
■■<br />
■■<br />
––<br />
abacavir sulfate<br />
––<br />
abacavir oral solution<br />
––<br />
nevirapine<br />
––<br />
nevirapine oral suspension<br />
––<br />
nevirapine tablets<br />
––<br />
tenofovir disoproxil fumarate<br />
for antimalarial medicines<br />
––<br />
artesunate<br />
––<br />
artesunate tablets<br />
––<br />
artesunate for injection<br />
––<br />
artemisinin<br />
––<br />
mefloquine hydrochloride<br />
for antituberculosis medicines<br />
––<br />
cycloserine<br />
––<br />
cycloserine capsules<br />
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