WHO Technical Report Series, No. 961, 2011, Annex 8 - These guidelines are intended to provide a description of ways in which pharmacists can improve access to health care, health promotion and the use of medicines on behalf of the patients they serve. The role of FIP is to provide leadership for na...tional pharmacy professional organizations, which in turn provide the impetus for setting national standards. The vital element is the commitment of the pharmacy profession worldwide to promoting excellence in practice for the benefi t of those served. The public and other professions will judge the pharmacy profession on how its members translate that commitment into practice in all settings, especially community and hospital pharmacy settings.
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WHO Annual Meeting with Pharmaceutical Companies and Stakeholders
08 March 2016, Geneva
2015-06-03 - Board presentation - v32.pptx
This report, published in conjunction with a summary overview of results of rounds 1–8, is the eighth and final report in a series of laboratory-based evaluations of rapid diagnostic tests (RDTs) for malaria. It provides a comparative measure of their performance in a standardized way to distingu...ish between well and poorly performing tests.
These results constitute the laboratory evaluation component of the WHO prequalification process for malaria RDTs and inform the current WHO procurement recommendations. In round 8, 35 RDTs from 17 manufacturers were assessed. For the first time the evaluation included an assessment of product performance against a panel of P. falciparum parasites with pfhrp2/3 gene deletions and therefore not expressing HRP2.
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Globally each year, millions of people suffer illness or lose their lives because the vaccines, medicines and diagnostic tests that they need are either unavailable or unaffordable – and this lack of access to medicine is acute in low- and middle-in-
come countries (LMICs). While the COVID-19 pan...demic laid this inequity bare, it also saw the pharmaceutical industry develop and bring new vaccines and treat- ments to market at unprecedented speed. As the world emerges from the worst
of this crisis, pharmaceutical companies are now at an important juncture, where lessons learned from the pandemic can prove pivotal in finding solutions to bridge long-standing gaps in access to medicine in LMICs.
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The Guidelines for the Diagnosis, Treatment and Prevention of Leprosy provide state-of-the-art knowledge and evidence on leprosy diagnosis, treatment and prevention based on a public health approach in endemic countries. The target audience of this document includes policy-makers in leprosy or infec...tious diseases in the ministries of health (especially but not limited to endemic countries), nongovernmental organizations, clinicians, pharmaceutical companies, donors and affected persons
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The survey aimed at evaluating the quality of selected antimalarials in six countries of sub-Saharan Africa (Cameroon, Ethiopia, Ghana, Kenya, Nigeria and the United Republic of Tanzania). These countries have been supported by WHO to strengthen their regulatory controls o...ver antimalarial products. The survey was organized independently of manufacturers of antimalarial medicines.
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This Medical Product Alert relates to the recent circulation of two confirmed falsified versions of Quinine
Sulphate circulating in Cameroon and the Democratic Republic of the Congo, containing zero active
pharmaceutical ingredient
The primary role of Benin’s Department of Pharmacy and Medicines (DPMED) is to develop and apply the national pharmaceutical policy. The main objective of this policy is to ensure the availability and accessibility of quality medicines for the population. To fulfill its mandate, DPMED aims to stre...ngthen its regulatory capacity, including the issuance of licenses to pharmaceutical establishments and the registration of pharmaceutical products. Benin’s current registration system shares core concerns that are common to most developing countries, notably the capacity to evaluate and monitor the security, efficacy, and quality of medicines and other health products. It is currently characterized by 1) poor or inadequate traceability of records or regulations (example: a product’s marketing authorization [MA] is often hard to find); 2) lack of evidence used in the regulatory decision-making process (reasons behind special import authorization, i.e., products without valid MAs); 3) inconsistent and unsecured archiving system; 4) limited human resources; and 5) an inefficient information management system
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The purpose of these guidelines is to help health workers to participate in the process of continuous surveillance of safety and efficacy of the pharmaceutical products which are used in clinical practice, thus help to achieve the ultimate goal to make safer and more effective treatment available to... patients. This guideline addresses specifically the issues on what to report, why to report, when to report, where to report and how to report.
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This report provides an update on the key facets of HIV treatment access, including the latest HIV treatment guidelines from World Health Organization (WHO), an overview on pricing for first-line, second-line, and salvage regimens, and a summary of the opportunities for – and threats to – expand...ing access to affordable antiretroviral therapy (ART).
The report is supplemented by 11 drug profiles that contain more detailed information on pricing trends and patent barriers for key antiretroviral drugs and fixed-dose combinations. Also included is an annex of conditions that define eligibility for reduced prices from 15 pharmaceutical companies.
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This document provides additional guidance for the responsible and prudent use of antimicrobials in food-producing animals, and should be read in conjunction with the Recommended International Code of Practice for Control of the Use of Veterinary Drugs CAC/RCP 38-1993. Its obj...ectives are to minimize the potential adverse impact on public health resulting from the use of antimicrobial agents in food-producing animals, in particular the development of antimicrobial resistance. It is also important to provide for the safe and effective use of veterinary antimicrobial drugs in veterinary medicine by maintaining their efficacy. This document defines the respective responsibilities of authorities and groups involved in the authorization, production, control, distribution and use of veterinary antimicrobials such as the national regulatory authorities, the veterinary pharmaceutical industry, veterinarians, distributors and producers of food-producing animals.
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Antimicrobial resistance is one of the most important threats to the health worldwide. Antimicrobial resistance or drug resistance is the reduction of the pharmaceutical effects of a drug against a disease or reduction of its effectiveness in improving the clinical signs of a disease. Antimicrobial ...resistance occurs naturally but misuse of antibiotics in human and animals significantly accelerates the process of developing antimicrobial resistance. In fact, antimicrobial resistance refers to the resistance of a microorganism to one or more antimicrobial drugs which had been previously sensitive to these drugs. Antimicrobial resistance can occur in a wide variety of pathogens including bacteria, parasites, viruses, fungi, and cancer cells and may threaten the life of every person, in every age, and in every country
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Accessed: 02.05.2020
These interim IPC recommendations for health settings have been developed through the contributions of many individuals and institutions, such as the Centers for Disease Control-Kenya; ITECH; US Agency for International Development (USAID) Medicines, Technologies, and Pharmaceu...tical Services (MTaPS) Program; and WHO that are committed to ensuring that the transmission of COVID-19 to HCWs and the public within the health care setting is limited. The Ministry of Health (MOH) through the Directorate of Health Standards Quality Assurance and Regulations wishes to thank all the contributing authors led by the sub-committee on case management and IPC for the COVID-19 response for their expertise and time given to writing these guidelines.
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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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Drug Distribution and Control: Preparation and Handling–Guidelines
Review 2008
Drug Distribution and Control: Preparation and Handling
This Technical Assistance Bulletin is intended to assist pharmacists in the extemporaneous compounding of non-sterile drug products for individual patients. Included in this document is information on facilities and equipment, ingredient... selection, training, documentation and record keeping, stability and beyond-use dating, packaging and labeling, and limited batch compounding. This document is not intended for manufacturers or licensed repackagers.
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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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Minimizing risk of developing antibiotic resistance and aquatic ecotoxicity in the environment resulting from the manufacturing of human antibiotic.
The Standard, facilitated by BSI Standards Limited (BSI), provides clear guidance to manufacturers in the global antibiotic supply chain to ensure t...hat their antibiotics are made responsibly, helping to minimize the risk of AMR in the environment.
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These guidelines provide updated evidence-based recommendations on the priority HCV-related topics from the 2018 WHO Guidelines for the care and treatment of persons diagnosed with chronic hepatitis C infection and the 2017 WHO Guidelines on hepatitis B and C testing. These priority areas are:
... direct-acting antiviral (DAA) treatment of adolescents and children ages ≥3 years of age
simplified HCV service delivery (decentralization, integration and task sharing)
HCV diagnostics – use of point-of-care (POC) HCV ribonucleic acid (RNA) assays and reflex HCV RNA testing.
These guidelines also update existing chapters without new recommendations, such as the inclusion of new manufacturers’ protocols on the use of dried blood spot (DBS) for HCV RNA testing and new data to inform the limit of detection for HCV RNA assays as a test of cure, in addition to their use for diagnosis.
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Pharmaceutical News
Evaluation of Saccharide Content of the WHO 2nd International Standard for Haemophilus Influenzae Polysaccharide Polyribosyl Ribitol Phosphate (PRP) by HPAECPAD Analysis Following Acid Hydrolysis
Consultation Documents
Lamivudine and tenofovir disoproxil fumarate tablets (lami...vudini et tenofoviri disoproxili fumarati compressi)
Tenofovir disoproxil fumarate tablets (tenofoviri disoproxili fumarati compressi)
ATC/DDD Classification
Temporary
Final
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