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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
...
Millennium Development Goal 8E aims for affordable access to essential medicines. Essential medicines, as defined by WHO, are those that “satisfy the health-care needs of the majority of the population” and that should therefore “be available at all times in adequate amounts”. However, there
...
Drug Advisory Board
Access to controlled medicines. 3rd edition
2nd edition - Published in 2003, the first WHO/HAI medicine prices manual Medicine Prices – A
New Approach to Measurement Draft for field-testing provides a draft methodology and tools to conduct national medicine prices and availability surveys. This second edition of the survey manual has been
...
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
...
Guidelines for Medicine Donations
recommended
This 3rd edition of Guidelines for medicine donations has been developed by the World Health Organization (WHO) in cooperation with major international agencies active in humanitarian relief and development assistance. The guidelines are intended to improve the quality of medicine donations in inter
...
The growing challenges for people in low and middle-income countries to access new medicines.
Analysis 58
Replacement of Annex 2 of WHO Technical Report Series, No. 964
...
WHO Technical Report Series, No. 908, 2003, Annex 9. This guide is intended for those involved in the storage, transportation and distribution of pharmaceuticals. It describes the special measures considered appropriate for the storage and transportation of pharmaceuticals.
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
...
