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Fact Book on WHO Level I and Level II monitoring indicators - To monitor the progress of efforts to improve the global medicines situation, WHO has developed a system of indicators that measure important aspects of a country’s pharmaceutical situation. Level 1 indicators measure the existence and ...
There is an urgent need for safer, simpler, more efficacious and accessible treatment regimens for all forms of TB. The development of Target Product Profiles for TB treatment regimens (referred to as Target Regimen Profiles or TRPs) seeks to guide the drug development process towards important regi...
The guidelines reiterate that the general principles of ethics for biomedical research involving human participants shall also be applicable. In addition, the guidelines specify unique provisions for stem cells, because of their inherent property for unlimited proliferation, differentiation to cells...
A resource for pesticide registrars and regulators.
The WHO urged governments to restrict access to highly toxic pesticides used for self-poisoning . Other effective interventions include education, youth intervention programs and follow-up of people at risk—and better data. Only 80 out of 183 WH...
The purpose of adding the books to the website of MCAI for download, is to make this life-saving, up-to-date information available to all who need it. Fill in a short registration field and you can download the pdf-files.
If you work in a hospital in a low income country - providing free care - y...
Guidelines for the registration of microbial, botanical and semiochemical pest control agents for plant protection and public health uses.
These guidelines are intended to guide pesticide regulatory authorities in the registration of microbial, botanical, and semiochemical pest control agents for p...
3rd Edition – July 2017
www.msfaccess.org
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
...
Rwanda Guidelines for variation to registered pharmaceutical products.
Medicines and Allied Substances [No. 3 of 2013 47 | An Act to continue the existence of the Pharmaceutical Regulatory Authority and re-name it as the Zambia Medicines Regulatory Authority; provide for the functions and powers of the Authority; provide for the registration and regulation of pharmacie...
This guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.
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...
Overcoming barriers in low- and middle-income countries
For the first time, this year’s report includes information on hepatitis C diagnostics. With a focus on selected countries with diverse HCV epidemics, the report provides updates on the various dimensions of access to HCV diagnostics and pha...
Preferred product characteristics” (PPCs) are key tools to incentivize and guide the development of urgently needed health products. The PPC published here describes the characteristics of new types of insecticide-treated nets (ITNs) to control malaria transmission in areas with insecticide-resist...
The purpose of this TPP is to communicate the minimum and ideal characteristics desired to meet the need for discriminating low levels of risk for transmission, i.e. targeted prevalence thresholds in the surveyed areas. An in vitro diagnostic test is needed for the detection of analyte(s) specific t...
Soil-transmitted helminths are a group of intestinal worms that include Ascaris lumbricoides (giant roundworm), Trichuris trichiura (whipworm), and Ancylostoma spp. (A. duodenale, A. ceylanicum) and Necator americanus (hookworms). Despite the clear biological differences among the different species,...
Health ministries currently lack effective tools for monitoring and evaluation of schistosomiasis control programmes. Egg detection can be used, but the cost, challenges of obtaining samples, and the need for trained personnel and equipment limit the frequency of monitoring. The purpose of this TPP ...
Drug registration in Kenya started in 1982; the process mainly involves an evaluation committee at the Kenya Pharmacy and Poisons Board (PPB) that aims to approve products based on quality, safety and efficacy.
This was a Phase 3, multi-center, randomized, open-label, parallel-group, active control study where 273 male and female patients with first stage Trypanosoma brucei gambiense HAT were treated at six sites: one trypanosomiasis reference center in Angola, one hospital in South Sudan, and four hospita...
