National regulatory authority Archives

WHO Regulatory Systems

Administrator

National regulatory authority Quamed News

16 Nov 2021

The WHO Regulatory Systems Strengthening team has made the “Implementing quality management systems in national regulatory authorities: examples and practices” document available in different languages including French, Russian and Spanish. French: https://apps.who.int/iris/bitstream/handle/10665/348379/9789240034105-fre.pdf Russian: https://apps.who.int/iris/bitstream/handle/10665/341942/9789240034143-rus.pdf Spanish: https://apps.who.int/iris/bitstream/handle/10665/348380/9789240034129-spa.pdf The English version is also available here: https://apps.who.int/iris/bitstream/handle/10665/341942/9789240022379-eng.pdf

WHO benchmarking tool

Ed Vreeke

National regulatory authority QA standards Quality assurance Quamed News

16 Jan 2021

A brief update on the WHO benchmarking tool. As can be seen in the screen shot below, there are two NRAs in sub-Saharan Africa with maturity level 3: Tanzania and Ghana. https://www.who.int/medicines/areas/regulation/nras_ml3_ml4/en/ A revised Global Benchmarking Tool (GBT) user’s manual is currently under development. As soon as it is available we will add a link ...

National Regulatory Systems in SADC

Administrator

International National regulatory authority News

11 Oct 2020

WHO AFRO Regional Office report on their rapid assessment of the the national regulatory systems in the Southern African Development Community in the Journal of Pharmaceutical Policy and Practice. It can be downloaded from the JPPP site (open access) by clicking on the title of the article: “A rapid assessment of the National Regulatory Systems ...