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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)...
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
...
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,...
Review over the work and challenges of the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) in combatting counterfeiting of medicines in Nigeria.
At least half of the world’s population does not have full coverage of essential health services. Health expenses push more than 100 million people into extreme poverty each and every year, forcing them into terrible choices that no one should ever have to make: Buy medicine or food? Education or ...
The World Heart Federation (WHF) Roadmap series covers a large range of cardiovascular conditions. These Roadmaps identify potential roadblocks and their solutions to improve the prevention, detection and management of cardiovascular diseases and provide a generic global framework available for loca...
Background
Asthma remains highly prevalent, with more severe symptoms in low-income to middle-income countries (LMICs) compared with high-income countries. Identifying risk factors for severe asthma symptoms can assist with improving outcomes. We aimed to determine the prevalence, severity and ris...
Handbook of HUMANITARIAN HEALTH CARE LOGISTICS Designing the Supply Network and Managing the Flows of Information and Health Care Goods in Humanitarian Assistance during Complex Political Emergencies
This report documents different approaches to conservation of medicinal plants and traditional knowledge in Bolipara union of Thanchi upazila of Bandarban hill district. This initiative involved the collection of baseline data on medicinal plants and their uses, motivating people towards the uses an...
Three Years After Enactment of the Drug Quality and Security Act
In preparing this paper, the Pharmacovigilance Group of the Pan American Health Organization’s Pan American Network for Drug Regulatory Harmonization (PANDRH) adopted the perspective of PAHO/WHO, which considers Pharmacovigilance, an essential component of public health programs. Its intention was...
Trop. Med. Infect. Dis. 2018, 3, 72;
The study identified some key determinants of untimely and incomplete childhood vaccinations in the context of Bangladesh. The findings will contribute to the improvement of age-specific vaccination and support policy makers in taking the necessary control ...
The study identified some key determinants of untimely and incomplete childhood vaccinations in the context of Bangladesh. The findings will contribute to the improvement of age-specific vaccination and support policy makers in taking the necessary control ...
This catalogue provides tools and information resources to support EU/EEA countries in addressing the challenging issue of vaccine hesitancy. The catalogue provides examples of practices that can serve as a resource for other countries. The project was developed in the context of ECDC’s support fo...
Final Report
Submitted to: Unicef, New Delhi
ORG Centre for Social Research (A Division of AC Nielsen ORG- MARG Private Limited)
Accessed: 30.10.2019
