Discussion paper initially prepared in April 2015 to facilitate feedback, and finalized after the
June 2015 meeting of WHO’s Strategic and Technical Advisory Group for TB (STAG-TB).
Session V: Regulatory & quality assurance aspects
Update on prequalification of ARVs and regional harmonisation of medicine registration
Deusdedit K. Mubangizi
Group Lead, Inspections, WHO-PQT E-mail: mubangizid@who.int
Acknowledgements:
• Matthias Stahl
• Milan Smid
• Antony Fake
...• Jacqueline Sawyer
• Iveta Streipa
D-Building – UNAIDS
Kofi A. Annan Meeting Room
Wednesday, 9 March 2016 11:15 – 11:30
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WHO has issued a new recommendation on the length of bladder catheterization following surgical repair of a simple obstetric urinary fistula. Currently the length of catheterization is not standard and ranges from 5 to 42 days. The new guidance recommends a 7–10 day period of bladder catheterizati...on to allow complete healing. Longer periods of catheterization can be inconvenient for the woman, her family and care providers as it is associated with more discomfort and inconvenience. It also increases the risk of infection and erosion related to catheterization; requires more intensive nursing care and costs more per patient.
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The Strategic plan aims to ensure alignment of preparedness and readiness actions in the nine countries focusing on eight technical areas: strengthening multisectoral coordination; surveillance for early detection; laboratory diagnostic capacity; points of entry; rapid response teams; risk communica...tion, social mobilization and community engagement; case management and infection prevention and control (IPC) capacities; and, operations support and logistics. The purpose of the WHO Regional Strategic Plan is to ensure that the countries bordering the Democratic Republic of the Congo are prepared and ready to implement timely and effective risk mitigation, detection and response measures should there be any importation of EVD cases.
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The HIV drug resistance report 2021 summarizes findings from 38 countries that had finalized the surveys by the time of this report and shared data with WHO.
Pretreatment HIVDR to non-nucleoside reverse-transcriptase inhibitors (NNRTI) can affect more than 10% of adults starting therapy and is fo...und up to 3 times more often in people who had previous exposure to antiretroviral drugs. In addition, nearly half of infants newly diagnosed with HIV has HIVDR to NNRTI before initiating treatment.The high levels of observed NNRTI pretreatment HIVDR among emphasize the need to fast-track the transition to WHO-recommended dolutegravir-based ART.
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Replacement of Annex 2 of WHO Technical Report Series, No. 964... morbidity. These preparations are included in the WHO List of Essential Medicines and should be part of any primary health care package where snakebites occur. Currently, there is an urgent need to ensure availability of safe, effective and affordable antivenoms, particularly to those in developing countries and to improve the regulatory control over the manufacture, import and sale of antivenoms.>
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The Regional strategy for measles control recommends that a second opportunity for measles immunization be provided to all children irrespective of their vaccination status or history of clinical measles. The preferred method of provision of a second opportunity is through Supplemental Immunization ...Activities (SIAs) targeting children 9 months to 14 years in catch-up campaigns and 9 months to 4 or 5 years during periodic follow-up campaigns
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In recent years, high prices of pharmaceutical products have posed challenges in high- and low-income countries alike. In many instances, high prices of pharmaceutical products have led to significant financial hardship for individuals and negatively impacted on healthcare systems’ ability to prov...ide population-wide access to essential medicines.
Pharmaceutical pricing policies need to be carefully planned, carried out, and regularly checked and revised according to changing conditions. Strong, well-thought-out policies can guide well-informed and balanced decisions to achieve affordable access to essential health products.
This guideline replaces the 2015 WHO guideline on country pharmaceutical pricing policies, revised to reflect the growing body of literature since the last evidence review in 2010. This update also recognizes country experiences in managing the prices of pharmaceutical products.
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Millennium Development Goal 8E aims for affordable access to essential medicines. Essential medicines, as defined by WHO, are those that “satisfy the health-care needs of the majority of the population” and that should therefore “be available at all times in adequate amounts”. However, there... is a category of medicines that faces a unique challenge in terms of availability. These are the medicines governed by the international conventions on narcotic and psychotropic substances. “Controlled medicines” is the common definition for pharmaceuticals whose active principles are listed under the 1961 United Nations Single Convention on Narcotic Drugs as amended by the 1972 Protocol, such as morphine and methadone; the 1971 United Nations Convention on Psychotropic Substances, such as diazepam and buprenorphine; and the 1988 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, such as ergometrine and ephedrine. The conventions list substances in “Schedules” according to their different levels of potential for abuse and harm, and the commensurate severity of control measures to be applied by countries.
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The Global Vaccine Action Plan (GVAP) 2011-2020, endorsed by Member States during the May 2012 World Health Assembly, has set ambitious targets to improve access to immunization and tackle vaccine-preventable diseases. This responsibility has been translated into firm commitments in February 2016, t...hrough the signature of the Addis Declaration on Immunization (ADI) by African Ministers and subsequently endorsed by the Heads of States from across Africa at the 28th African Union Summit held in January 2017. This commitment from the highest level of government comes as a catalyst to immunization efforts on the continent to deliver on the promise of universal immunization
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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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This publication is an updated version of the Management of Tuberculosis and HIV Coinfection clinical protocol released in 2007 by the WHO Regional Office for Europe. It is intended for all health care workers involved in preventing, diagnosing, treating and caring for people living with TB and HIV ...in the specific settings of the WHO European Region.
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Humanitarian emergencies result in a breakdown of critical health-care services and often make vulnerable communities dependent on external agencies for care. In resource-constrained settings, this may occur against a backdrop of extreme poverty, malnutrition, insecurity, low literacy and poor infra...structure. Under these circumstances, providing food, water and shelter and limiting communicable disease outbreaks become primary concerns. Where effective and safe vaccines are available to mitigate the risk of disease outbreaks, their potential deployment is a key consideration in meeting emergency health needs. Ethical considerations are crucial when deciding on vaccine deployment. Allocation of vaccines in short supply, target groups, delivery strategies, surveillance and research during acute humanitarian emergencies all involve ethical considerations that often arise from the tension between individual and common good. The authors lay out the ethical issues that policy-makers need to bear in mind when considering the deployment of mass vaccination during humanitarian emergencies, including beneficence (duty of care and the rule of rescue), non-maleficence, autonomy and consent, and distributive and procedural justice
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Undernutrition increases the risk of tuberculosis (TB) and in turn TB can lead to malnutrition. Undernutrition is therefore highly prevalent among people with TB. It has been demonstrated that undernutrition is a risk factor for progression from TB infection to active TB disease and that undernutrit...ion at the time of diagnosis of active TB is a predictor of increased risk of death and TB relapse. However, the evidence concerning the effect of nutritional supplementation on TB prevention and health outcomes among people with TB had not previously been systematically reviewed. This guideline provides guidance on the principles and recommendations for nutritional care and support of patients with TB as part of their regular TB care
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