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WHO Technical Report Series, No. 957 - Multiple Choices - World ...

WHO Technical Report Series, No. 957 - Multiple Choices - World ...

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of information, the Expert Committee recommended the setting up of anautomatic notification system of updates or news on the Ph.Int.One-day briefing on The International PharmacopoeiaThe Secretariat informed the Expert Committee that a one-day overviewof the Ph.Int. was given in April 2009 to industrial stakeholders. Thisincluded describing the process for developing monographs, together withexplanations of the pharmacopoeial approach and policy on a variety ofissues and of the role of the pharmacopoeia within <strong>WHO</strong> quality assuranceactivities. The meeting was interactive and informal to allow manufacturers(mostly those already collaborating with QSM) to raise issues and to haveopen discussions on the Ph.Int.It was attended by representatives from generic and research-basedpharmaceutical companies as well as pharmaceutical industry associations.The positive feedback received showed that the information provided washelpful and that the briefing session would assist in future collaborations inthe development of monographs for the Ph.Int.In response to requests from the participants to consider a future briefingwith a larger audience, the Expert Committee recommended that the <strong>WHO</strong>Secretariat continue with organizing such information sessions.3.2 Current work plan and future work programmeIn order to respond to the needs of <strong>WHO</strong> programmes and partnerorganizations, the Expert Committee agreed in 2008 to only considerfor inclusion in the work programme those substances that had beenassigned a high priority. A work plan, including a first group of six activepharmaceutical ingredients (APIs) and 36 dosage forms for monographinitiation, was thus adopted.Since good progress had been made in developing specifications from the 2009work plan, a new work programme, including a second group for monographinitiation, was proposed to the Expert Committee, taking into account:— substances remaining from the 2009 work plan;— substances initially listed in the adopted work programme in 2008 thathad now been prioritized, focusing on medicines for children, medicinesimportant for the treatment of HIV/AIDS, tuberculosis and malaria andtreatment of diseases with a high prevalence in developing countries);— additions from the sixteenth Model list of essential medicines and thesecond List of essential medicines for children;— additions from the expressions of interests (EOIs) within the <strong>WHO</strong>Prequalification Programme (PQP); and19

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