UNICEF, WHO sound alert

Billions of people around the world are continuing to suffer from poor access to water, sanitation and hygiene, according to a new report by UNICEF and the World Health Organization. Some 2.2 billion people around the world do not have safely managed drinking water services, 4.2 billion people do not have safely managed sanitation services, and 3 billion lack basic hand-washing facilities. The report of the Joint Monitoring Programme finds that while significant progress has been made toward achieving universal access to basic water, sanitation and hygiene, there are huge gaps in the quality of services provided.

“Mere access is not enough. If the water isn’t clean, isn’t safe to drink or is far away, and if toilet access is unsafe or limited, then we’re not delivering for the world’s children,” said Kelly Ann Naylor, Associate Director of Water, Sanitation and Hygiene, UNICEF. “Children and their families in poor and rural communities are most at risk of being left behind. Governments must invest in their communities if we are going to bridge these economic and geographic divides and deliver this essential human right,” a note from the WHO said.

Paediatric diabetes

USFDA approval for injection

The US Food and Drug Administration has approved Victoza (liraglutide) injection for treatment of paediatric patients 10 years or older with type 2 diabetes. Victoza is the first non-insulin drug approved to treat type 2 diabetes in paediatric patients since metformin was approved for paediatric use in 2000. Victoza has been approved to treat adult patients with type 2 diabetes since 2010. Lisa Yanoff, acting director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, said, “Victoza has now been shown to improve blood sugar control in paediatric patients with type 2 diabetes. The expanded indication provides an additional treatment option at a time when an increasing number of children are being diagnosed with this disease.”Type 2 diabetes is the most common form of diabetes, occurring when the pancreas cannot make enough insulin to keep blood sugar at normal levels. Although type 2 diabetes primarily occurs in patients over the age of 45, the prevalence rate among younger patients has been rising dramatically over the past couple of decades.

EU-US mutual recognition pact

Luxembourg, Netherlands included

Luxembourg and the Netherlands were included, earlier this month, in the mutual recognition agreement between the European Union (EU) and the United States Food and Drug Administration (FDA). The FDA thus confirmed the capability of these two additional EU Member States to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. The agreement mutually recognises inspections of manufacturing sites for human medicines conducted in the different territories and this means the FDA will now rely on a total of 26 Member States whose inspection results can replace their own inspections.

In June 2017, the European Commission confirmed that the FDA has the capability, capacity and procedures in place to carry out GMP inspections at a level equivalent to the EU. Since 1 November, 2017, EU Member States and EMA can rely on inspection results from the FDA, a note from the European Medicines Agency said. Actions for the agreement to be operational in all EU Member States are progressing. The planned date of operation is July 15, 2019.

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