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The document contains a set of indicators that can be used for monitoring traditional and complementary medicine (T&CM) systems in a country.
The core indicator set consists of 16 indicators that were considered essential and collectively able to p
...
rovide information on T&CM inputs, processes and outputs. A longer list of reference indicators is also available for countries that wish to monitor more indicators or that want to consider alternative metrics that would better suit each country’s T&CM situation, priorities and monitoring capacities.
Each core and reference indicator is accompanied by a set of metadata. This provides information on the indicator rationale, definitions, data elements (numerator, denominator and data disaggregation), frequency of measurement, and data sources. It is a guide towards more standardized data measurement as well as data interpretation.
more
The manufacturing process is one of the key steps where quality control is required to ensure quality of medicinal products, including herbal medicines. Good manufacturing practices (GMP) is one of the most important tools for this measure.
3rd edition!Large File 17 MB!
The Antimicrobial Resistance Benchmark has evaluated for the second time how the most important players in the antibiotic market are addressing the rise of resistance and the global need for appropriate access to antibiotics. Although we can see progress — it’s hanging by a thread.
We have reac
...
hed a tipping point where large and prominent drugmakers have retreated from the antibiotics field and smaller innovative biotech companies have gone bankrupt due to the poor financial rewards on offer.
more
Namibia guideline for submission of applications for registration of pharmaceuticals for human use in common technical document format.
Accessed November 2017
This guideline provides advice in regards to applications for Marketing Authorisations for antimicrobial veterinary medicinal products (VMPs) on the data required and the methodology to be used for performing an assessment of the risk to public health from antimicrobial resistance (AMR) due to use o
...
f the product. The scope of the guidance extends to VMPs intended for food producing species and to the transmission of AMR by the foodborne route or through direct contact with treated animals.
more
Development of one or more vaccines for Neisseria gonorrhoeae is an important objective for sexual and reproductive health worldwide, and for the fight against antimicrobial resistance.
WHO preferred product characteristics (PPCs) provide strateg
...
ic guidance as to WHO’s preferences for new vaccines in priority disease areas. PPCs are intended to encourage innovation and development of vaccines for use in settings most relevant to the global unmet public health need.
Gonococcal vaccine PPCs describe global public health goals for gonococcal vaccines and preferred parameters pertaining to vaccine indications and target populations, safety and efficacy considerations, and immunization strategies.
more
In September, 2018, the first international Medicine Quality and Public Health Conference was held at Oxford University, UK, to discuss opportunities and solutions to ensure that all people have access to affordable and quality-assured medical produ
...
cts. Delegates developed the short Oxford Statement, calling for investment, policy change, and action to eliminate substandard and falsified medical products. The statement was born out of discussion between governments, national and international agencies, non-governmental organisations, professional associations, and academic institutions who together examined the latest evidence on the epidemiology and public health implications of substandard and falsified medical products.
more
TheoreticalMedicine 6 (1985), 281-294. 0167-9902/85.10
PQM conducted an assessment of the medicine quality assurance and quality control systems in Rwanda during November 9-13, 2009. Medicine quality assurance remains to be developed in Rwanda: the coun
...
try has neither a medicine regulatory authority (MRA) nor a national medicine quality control laboratory – the two key institutions to ensure the quality, safety, and efficacy of medicines. The MOH Pharmacy Taskforce (PTF) is to be commended however for successfully controlling the pharmaceutical market to the extent that there is no informal medicines market in Rwanda. Based on its findings, the assessment team expects Rwanda to be able to make great strides in evidence-based medicines quality assurance in the short to medium term, provided it receives adequate technical assistance and financial support.
more
The extensive use of antimicrobials in human and veterinary medicine in recent years has accelerated the emergence and spread of resistant microorganisms. This situation has been worsened by the lack of investment in developing new effective antibio
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tics. The severity of the consequences is clear to see: it is estimated that each year, drug-resistant infections result in at least 25 000 patient deaths and cost the EU EUR 1,5 billion in healthcare costs and through loss of productivity
more
Despite the development of point-of-care diagnostic tests for syphilis, chlamydia, gonorrhoea, and trichomoniasis, none comply with all WHO criteria. This analysis overviews landscape analyses of point-of-care diagnostic technologies for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vagi
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nalis and syphilis, available and in the pipeline. The target audience for the target product profiles is broad and includes clinicians, researchers working on diagnostics, laboratory experts, including, microbiologists and virologists, public health experts, epidemiologists, developers, and representatives for manufactures, including biotech engineers, policy-and decision-makers as well as representatives from regulatory bodies and agencies, donor agencies and international organizations.
more
PLOS Medicine | https://doi.org/10.1371/journal.pmed.1002514 March 1, 2018
PLOS Medicine | DOI:10.1371/journal.pmed.1002088 August 23, 2016
