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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China is one of the major countries for the production and use of antibacterial agents. Antibacterial agents are widely used in healthcare and animal husbandry. It plays a significant role in treating infections and saving patient lives, preventing and treating animal diseases, improving farming ef...ficiency, and guaranteeing public health security. However, antimicrobial resistance has become increasingly prominent due to insufficient research and development capacity of new antimicrobials, sales of antimicrobials without prescriptions in pharmacies, irrational use of antibacterial agents in medical and food animal sectors, non-compliant waste emissions of pharmaceutical enterprises, as well as lack of public awareness toward rational use of antimicrobials. Bacterial resistance ultimately affects human health, but the cause of bacterial resistance and consequences are beyond the health sector. Antimicrobial resistance brings increasing biosecurity threats, worsens environmental pollution, constrains economic development and other adverse effects to human society, thus, there is an urgent need to strengthen multi-sectoral and multi-domain collaborative planning to jointly cope with this issue.
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The aim of the SATG was to produce a triage scale for use throughout South Africa. The group was multi-disciplinary and comprised doctors, nurses and paramedics. The result of the SATG’s activities is the South African Triage Scale (SATS), a physiology and symptom based scale which prioritises int...o one of four colours and can be used in hospital Emergency Centres as well as in the pre-hospital setting. The SATS has been validated in the public, private health care setting as well as pre-hospital.
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During fresh fruit and vegetables (FFV) production, water is used for a variety of purposes. Even the water was conventionally treated and disinfected, it may still potentially contain human pathogens, albeit at low concentrations. A risk assessment, appropriate to the national or local production c...ontext, should be conducted to assess the potential risks associated with a specific water source or supply in order to devise the appropriate risk mitigation strategies.
Since the 48th session of Codex Committee on Food Hygiene (CCFH) noted the importance of water safety and quality in food production and processing, FAO and WHO has undertaken the work on this subject. This report describes the output of the third in a series of meetings, which examined appropriate and fit-for-purpose microbiological criteria for water used with fresh fruit and vegetables. The advice herein will support decision making when applying the concept of fit-for-purpose water for use in the pre- and post-harvest production of fresh fruit and vegetables.
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The publication of the Second Edition of the Emergency Drug Guidelines represents the culmination of the efforts of the National Drugs and Therapeutics Committee (NDTC) to publish clinical drug guidelines for common diseases seen in Fiji. These guidelines are targeted for health care professionals w...orking at hospitals and at the primary health care settings. It sets the gold standard for the use of drugs in the treatment of emergency medical conditions in Fiji. The guidelines have taken into account the drugs available in the Fiji Essential Medicines Formulary (EMF), 2006 Edition, in recommending treatment approaches. All recommended therapies are either evidencebased or universally accepted standards
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Despite high regional demand for vaccines valued at over US$ 1 billion annually, Africa’s vaccine industry provides only 0.1% of global supply. Vaccine inequity and hoarding at the start of the pandemic, which resulted in delays in obtaining COVID-19 doses, stimulated new resolve to address future... supply security. In 2021, the AU set a target to produce and supply more than 60% of the vaccine doses on the continent by 2040.
In the last 18 months alone, more than 30 new African manufacturing projects have been announced and estimates indicate that the African vaccine market across all existing and projected novel products could range between US$ 2.8 billion and US$ 5.6 billion by 2040*, demonstrating the potential for a thriving regional industry to emerge.
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This volume introduces Mongolian traditional medicine and details the nature and uses of medicinal plants found in the country.
The book focuses on the medicinal plants used most commonly in Mongolia. Each monograph contains colour pictures of the plant and a wide array of information—from the sc...ientific and English names of plants to their microscopic characteristics. While helping record and document traditional medicine practices, the book contributes to the understanding of the value of medicinal plants in Mongolia and increases the evidence base for the safe and efficacious use of herbs in health care.
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A formulary of dermatological preparations and background information on therapeutic choices, production and dispensing. 2nd edition
WHO Model Formulary for children based on the Second Model List of Essential Medicines for Children 2009.
In 2007, the World Health Assembly passed a Resolution titled ‘Better Medicines for Children’. This resolution recognized the need for research and development into medicines for children,... including better dosage forms, better evidence and better information about how to ensure that medicines for treating the common childhood diseases are given at the right dose for children of all ages.
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The aim of these Guidelines is to provide a framework for the conservation and sustainable use of plants in medicine. To do this, the Guidelines describe the various tasks that should be carried out to ensure that where medicinal plants are taken from the wild, they are taken on a basis that is sust...ainable.
The Guidelines conform to the principles of Caring for the Earth, prepared in partnership by IUCN, UNEP and WWF. Caring for the Earth extends the message and scope of the World Conservation Strategy to an ethic of sustainable living, and explains how to integrate conservation with development. Its message is particularly relevant to the issue of medicinal plants, which in many parts of the world are being seriously depleted due to over-exploitation and loss of habitats, resulting in a lack of essential medicines and so reducing options for the future.
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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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Interagency Guidelines; Medicines and medical devices for 10 000 people for approximately three month.
Ensuring Access to Simple, Safe and Effective First-Line Medicines for Tuberculosis.
Accessed in November 2017.
Communication to Healthcare Professionals Mar-2020
This guideline is intended to assist healthcare professionals in the participation of very important process of continuous surveillance of safety and efficacy of the health products which are used in their clinical practice. Continuous evaluation o...f medicines’ benefit and harm help to achieve the ultimate goal of safe and effective treatments available to patients.
The guideline is intended to assist healthcare professionals in the reporting of suspected adverse drug reactions (ADRs) associated with the use of all registered health products, including medicines, old medicines, medical devices and in-vitro diagnostics (IVDs).
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This Indicator-Based Pharmacovigilance Assessment Tool (IPAT) was developed as a comprehensive performance metric for pharmacovigilance and medicine safety systems.
Good Manufacturing Practice (GMP) describes a set of principles and procedures that, when followed, ensure that medicines and related substances are of high quality, safety and efficacy. SAHPRA is a
participating authority of the Pharmaceutical Inspection Cooperation Scheme (jointly known as PIC/S).... PIC/S aims to develop international standards between countries and pharmaceutical inspection
authorities, to provide harmonised and constructive co-operation in the field of GMP. PIC/S affiliation is subject to initial and periodic assessment of the participating authority to ensure that it has equivalent legislation, regulatory and enforcement procedures and inspection capacity.
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Pharmaceutical regulators are at the forefront of ensuring that only safe and effective medicines are authorized and available in the market. This document builds on the recommendations in the above publication and has been prepared to specifically assist national medicines regulatory authorities to... understand the nature and extent of oxytocin quality issues and to provide key technical information and quality requirements for oxytocin products in dossier assessments. Furthermore, this document also presents recommendations on other regulatory actions needed to ensure that only quality-assured oxytocin products are authorized and made available to women.
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Review over the work and challenges of the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) in combatting counterfeiting of medicines in Nigeria.
Building on our decades of commitment to human rights in medicine and healthcare, we have published a new report on emerging threats in health-related human rights both globally and in the UK.
'Health and human rights in the new world (dis)order' outlines a shifting rights landscape in which new ...technologies, environmental change and geopolitical reconfigurations are putting renewed and at times intense stress on human rights, both in medicine and healthcare more broadly.
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