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This Implementation Kit (I-Kit), developed by the Health Communication Capacity Collaborative (HC3), helps national and local stakeholders to design country-specific social and behavioural change communication (SBCC) campaigns that address the threat posed by substandard, spurious, falsified and fal...
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 country has neither a medicine regulatory authority (MRA) nor a national medicine quality control laborato...
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...
Antimicrobial resistance (AMR) is occurring everywhere in the world, compromising the ability to treat infectious diseases, as well as undermining many other advances in health and medicine. Underlying factors that drive AMR include; weak or absent surveillance and monitoring systems, inadequate sys...
An Act to provide for the efficient and comprehensive regulation and control of food, drugs, medical devices, cosmetics, herbal drugs and poisons and to repeal the Food
(Control of Quality) Act, 1978, the Pharmaceuticals and Poisons Act, 1978 and to provide for related matters.
Survey of the Quality of Selected Antimalarial Medicines Circulating in Six Countries of Sub-Saharan Africa
recommended
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...
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...
The prevalence, availability, and use of antimalarial medicines (AMLs) were studied in six Cambodian provinces along the Thai-Cambodian border. The study was divided into two parts: the first looked at the quality of AMLs available in Pursat, Pailin, Battambang, Bantey Meanchey, Oddar Meanchey, and ...
Two test methods on dexamethasone tablets and injections
The occurrence of a high percentage of couterfeit medicines on the global medicines market is often attributed to a lack of effective regulation and a weak enforcement capacity. This review, while focusing on counterfeit medicines and medical devices in developing countries, will present information...
This interagency report provides recommendations for assuring quality of medicines during key activities of country-level procurement agencies, namely prequalification of pharmaceutical products and manufacturers; purchase of pharmaceutical products; storage of pharmaceutical products; and distribut...
Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status,...
Infection Control Assessment Tool
recommended
Strengthening Parmaceutical Systems. 2nd edition
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
...
Nosocomial or health-facility-acquired infections are a serious issue, representing one of the most significant causes of morbidity and mortality in healthcare systems and consuming many scarce resources, especially in developing countries. Although much has been done, particularly in the hospital s...
This document is a guide defining requirements for quality and safety for malaria rapid diagnostic testing services to safeguard the quality of the results, the safety of the operators and patients and that of the environment for use by national malaria control programmes, regulators, implementers a...
Antimicrobial resistance (AMR) is a global public health crisis that resulted in 1.14 million deaths in 2021. According to the Institute for Health Metrics and Evaluation estimates, 96 416 of these deaths occurred in the World Health Organization (WHO) Eastern Mediterranean Region. All 22 countr...
