The main objectives of these guidelines are to:
1. contribute to the quality assurance of medicinal plant materials used as the source for herbal medicines to improve the quality, safety and efficacy of finished herbal products;
2. guide the formulation of national and/or regional GACP guideli...nes and GACP monographs for medicinal plants and related standard operating procedures; and
3. encourage and support the sustainable cultivation and collection of medicinal plants of good quality in ways that respect and support the conservation of medicinal plants and the environment in general.
These guidelines concern the cultivation and collection of medicinal plants and include certain post-harvest operations.
more
For the first time in almost 50 years there are two new drugs for the treatment of drug-resistant TB (DR-TB): bedaquiline and delamanid. There has also been increased attention given to the safety and efficacy of “re-purposed” drugs that have been widely used to treat other infections but are al...so showing promise in the treatment of DR-TB, including linezolid and clofazimine. This special supplemental guide has been developed for nurses, because it is essential that nurses be provided with material that maximizes their ability to provide optimal support to patients who are receiving new and re-purposed drugs
more
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the Medicines Control Council’s current thinking on the safety, quality and efficacy of medicines.
Antimicrobial resistance (AMR) is a threat to human and animal health and refers to the ability of microorganisms to defy the medicines prescribed. For instance when antibiotics are used improperly, such as an incorrect dose, insufficient duration or wrong frequency, resistance is heightened. The mi...suse of antimicrobials affects their efficacy, and increasingly more infections and diseases become untreatable. Many gains made in modern medicine throughout the 20th century will be lost, making AMR a global public and animal health issue that requires concerted action. AMR and the use of antimicrobials (AMU) affect food safety and security, people’s livelihoods, as well as economic and agricultural development.
more
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.
more
The COVID-19 vaccine tracker and landscape compiles detailed information of each COVID-19 vaccine candidate in development by closely monitoring their progress through the pipeline.
The COVID-19 vaccine tracker:
Provides summary tables of COVID-19 vaccine candidates in both clinical and pre-...clinical development;
Provides analysis and visualization for several COVID-19 vaccine candidate categories;
Tracks the progress of each vaccine from pre-clinical, Phase 1, Phase 2 through to Phase 3 efficacy studies and including Phase 4 registered as interventional studies;
Provides links to published reports on safety, immunogenicity and efficacy data of the vaccine candidates;
Includes information on key attributes of each vaccine candidate and
Allows users to search for COVID-19 vaccines through various criteria such as vaccine platform, schedule of vaccination, route of administration, developer, trial phase and clinical endpoints.
The database is updated regularly - twice a week (Tuesday and Friday, 17:00 CET).
more
This chronology of facts has challenged public health systems worldwide and regulatory bodies are no exception. Regulatory authorities with mechanisms in place to authorize the use of investigational products had to development guidelines and procedures, create task forces and alliances to maximize ...the efficiency of assessment, review and authorizations of medical products. Vaccines are undoubtedly the most complex medical products to develop, from concept to a stage where sufficient evidence of quality, safety and efficacy are collected to provide an assurance that their use will provide more benefits than risks when used in the context of a public health emergency.
more
Weekly Epidemiological Record No 9, 2022, 97, 61–80
This position paper supersedes the 2016 publication, “Malaria vaccine: WHO position paper-2016.”1 It includes the updated WHO recommendations on the wider use of the RTS,S/AS01 vaccine for the reduction of malaria morbidity and mortality in ...children living in areas of moderate to high malaria transmission. It also incorporates findings from the evaluation of the WHO-coordinated Malaria Vaccine Implementation Programme (MVIP), recommended by SAGE and MPAG in 2015, and from additional studies since 2015.
This paper does not include findings on vaccine efficacy in infants first vaccinated at 6–12 weeks of age. Because of the lower vaccine efficacy observed in this age category, WHO did not recommend pilot implementation or RTS,S/AS01 vaccine introduction for these young infants. Recommendations2 on the use of RTS,S/AS01 vaccine were discussed by SAGE and MPAG during a joint session in October 2021; evidence presented at the meeting can be accessed at https://terrance.who.int/mediacentre/data/ sage/SAGE_eYB_Oct2021.pdf
more
Cases of human monkeypox are rarely seen outside of west and central Africa. There are few data regarding viral kinetics or the duration of viral shedding and no licensed treatments. Two oral drugs, brincidofovir and tecovirimat, have been approved for treatment of smallpox and have demonstrated eff...icacy against monkeypox in animals. Our aim was to describe the longitudinal clinical course of monkeypox in a high-income setting, coupled with viral dynamics, and any adverse events related to novel antiviral therapies.
more
2nd edition. These guidelines include several notable changes from the first edition. For cutaneous leishmaniasis, ketoconazole has been removed from the list of treatment options; the number of Leishmania species for which there is strong evidence for the efficacy of miltefosine has increased from ...two to four; and the recommendation for intralesional antimonials is now strong. For mucosal leishmaniasis there is now a strong recommendation for use of pentavalent antimonials with or without oral pentoxifylline. For visceral leishmaniasis, the strong recommendations for use of pentavalent antimonials and amphotericin B deoxycholate are now conditional.
more
The Lancet olume 395, ISSUE 10232, P1259-1267, April 18, 2020. Buruli ulcer is a neglected tropical disease caused by Mycobacterium ulcerans infection that damages the skin and subcutis. It is most prevalent in western and central Africa and Australia. Standard antimicrobial treatment with oral rifa...mpicin 10 mg/kg plus intramuscular streptomycin 15 mg/kg once daily for 8 weeks (RS8) is highly effective, but streptomycin injections are painful and potentially harmful. We aimed to compare the efficacy and tolerability of fully oral rifampicin 10 mg/kg plus clarithromycin 15 mg/kg extended release once daily for 8 weeks (RC8) with that of RS8 for treatment of early Buruli ulcer lesions.
more
On 15–16 December 2020, WHO and the Medicines for Malaria Venture co-convened a technical consultation to consider the preferred product characteristics (PPCs) for drugs used in malaria chemoprevention. The main goal of the technical consultation was to agree on the most important PPCs for drugs t...o protect populations from malaria (chemoprevention), while considering relevant measures of efficacy and the safety data needed to support WHO policy recommendations.
more
To support its R&D activities on Chagas disease, DNDi launched the Chagas Clinical Research Platform (CCRP). The platform brings together partners, experts, and stakeholders to provide support for evaluation and development of new treatments for Chagas disease. The patient-centred platform aims to f...acilitate clinical research, provide a forum for technical discussions, develop a critical mass of expertise, and strengthen institutional research capacities. In addition, it identifies and reviews priority needs, works towards standardization of methodology to assess drug efficacy and reviews alternatives for using current approved drugs (new schemes, doses, combination) and special scenarios (resistance).
more
Human African trypanosomiasis (HAT), or sleeping sickness, is a painful and protracted disease transmitted through the bite of infected tsetse flies and it is found in rural parts of sub-Saharan Africa. Sleeping sickness has two clinical phases but this review focuses only on treatment of the second...-stage, which is characterized by neurological changes and almost invariably fatal without treatment. There are only a few drugs currently available for second-stage sleeping sickness, all with considerable adverse events and variable efficacy.
The review includes nine trials with 2577 participants. Each trial reported different comparisons of the drugs currently available to treat second stage HAT (melarsoprol, eflornithine, nifurtimox) so no meta-analysis was possible.
more
This document focuses on the management of patients affected by gambiense HAT and
constitutes an update to the WHO therapeutic guidance issued in 2013. The main changes in recommendations concern the criteria and methods for deciding the treatment among the new set of therapeutic options and the pa...rticular conditions that apply to treatment with fexinidazole, as outlined below. Because HAT is a serious, life-threatening disease and because the efficacy of fexinidazole depends on swallowing the medicine after an appropriate intake of food as well as on completing the full 10-day
treatment schedule, the recommendations regarding fexinidazole administration are considered key elements that must be carefully followed. When the conditions listed in these guidelines are not met for any individual patient, the alternative available treatments should be prescribed.
more
A wide spectrum of disease severity has been described for Human African Trypanosomiasis (HAT) due to
Trypanosoma brucei rhodesiense (T.b. rhodesiense), ranging from chronic disease patterns in southern countries of East Africa to an increase in virulence towards the north. However, only limited d...ata on the clinical presentation of T.b. rhodesiense HAT is available. From 2006-2009 we conducted the first clinical trial program (I MPAMEL III) in T.b. rhodesiense endemic areas of
Tanzania and Uganda in accordance with international standards (ICH-GCP). The primary and secondary outcome measures were safety and efficacy of an abridged melarsoprol schedule for treatment of second stage disease. Based on diagnostic findings and clinical examinations at baseline we describe the clinical presentation of T.b. rhodesiense HAT in second stage patients from two distinct geographical settings in East Africa.
more
As of 12 December 2022, over 645 million people worldwide have been diagnosed with COVID-19, with over 6.6 million deaths (4).
The Omicron variant, which emerged in late November 2021, and its subvariants, are now the dominant circulating viruses, contributing to the ongoing surge in several countr...ies (4). Vaccination has substantially reduced case numbers and hospitalizations in many countries,but limitations in global access to vaccines mean that many populations, including those in low- and middle-income countries, remain vulnerable. Even in vaccinated individuals, uncertainties remain about duration of protection and efficacy, and the degree of crossprotection with new variants.
There remains a need for more effective treatment and management for those affected by COVID-19. The pandemic – and the
explosion of both research and misinformation – has highlighted the need for trustworthy, accessible and regularly updated living
guidelines to place emerging findings into context and provide clear recommendations for clinical practice
more
Clin Microbiol Infect 2010; 16: 225–231 Abstract In non-endemic countries, acute (invasive) schistosomiasis (AS) is typically seen in non-immune travellers, whereas chronic schistosomiasis is more frequently diagnosed in immigrants. Travellers with AS initially present with non-specific signs such... as fever, cough, headache, and urticaria. Life-threatening cardiac and neurological complications may occur. The positive diagnosis of AS relies on seroconversion, which appears together with hypereosinophilia approximately 3 weeks after the onset of symptoms. When prescribed during AS, praziquantel usually does not prevent the chronic phase of the disease and is associated with exacerbation of signs and symptoms in approximately 50% of cases. According to the published literature, corticosteroids may be recommended alone or in association with praziquantel. When associated with corticosteroids, pharmacokinetic interactions may impair the efficacy of praziquantel. We suggest that corticosteroids should be restricted to use in patients with systemic complications of AS, whereas praziquantel should be initiated only when ova are detected in either stools or urine, depending on the culprit species.
more
In 2014, an estimated 40 million women of reproductive age were infected with Schistosoma haematobium, S. japonicum and/or S. mansoni. In both 2003 and 2006, the World Health Organization (WHO) recommended that all schistosome-infected pregnant and breastfeeding women be offered treatment, with praz...iquantel, either individually or during treatment campaigns. In 2006, WHO also stated the need for randomized controlled trials to assess the safety and efficacy of such treatment. Some countries have yet to follow the recommendation on treatment and many programme managers and pregnant women in other countries remain reluctant to follow the recommended approach.
more
Chikungunya fever (CHIKF) is an emerging infectious disease caused by an alphavirus transmitted by Aedes spp. mosquitoes. Because mosquito control programs are not highly efficient for outbreak containment, vaccines are essential to reduce the burden of disease. Although no licensed vaccine against ...CHIKF is yet available, many highly promising candidates are undergoing preclinical studies, and a few of them have been tested in human trials of phase 1 or 2. Here, we review recent findings regarding the need for a CHIKF vaccine and provide an update on vaccines nearing or having entered clinical trials. We also address needs to tackle bottlenecks to vaccine development—including scientific and financial barriers—and to accelerate the development of vaccines; several actions should be taken:
(i) design efficacy trials to be conducted during the course of outbreaks;
(ii) evaluate the opportunity for adopting the “animal rule”for demonstration of efficacy for regulatory purposes;
(iii) strengthen the collective commitment of nations, international organizations, potential donors and industry;
(iv) stimulate public and/or private partnerships to invest in vaccine development and licensure; and
(v) identify potential markets for an effective and safe CHIKF vaccine.
more