Urgent Health Advisory: Substandard Medicines Alert – WHO N°8/2023

Medical Product Alert N°8/2023 Substandard (contaminated) syrup and suspension medicines have been identified in multiple WHO regions, including the Americas, Eastern Mediterranean, Southeast Asia, and the Western Pacific. Five products from PHARMIX LABORATORIES (PVT.) LTD, including ALERGO Syrup and ULCOFIN Suspension, have been found with dangerous levels of ethylene glycol, posing severe health risks like ...

Inside the 2023 UN Pharma Quality Summit in Copenhagen

This week, we had the privilege to participate in the 2023 Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers in Copenhagen. It was an opportunity to learn from colleagues about the latest developments around the UN organisations’ approach to pharmaceutical quality assurance and procurement. The session on Regulatory Updates was especially interesting.  It ...

QUAMED Engages in CIP GSG’s Strategic Summit for Regulatory Systems Strengthening

Last week, QUAMED participated in the second formal meeting of the CIP Global Steering Group (GSG) held on 9-10th November 2023 in the Hague, Netherlands. CIP (Coalition of Interested Parties) is a network for regulatory systems strengthening established by the World Health Organization (WHO) to promote a unified, strategic and coordinated approach to national and ...

Substandard (contaminated) syrup medicines identified in the WHO Region of Africa

A batch of NATURCOLD Syrup found in Cameroon has been flagged by WHO as contaminated with diethylene glycol, exceeding safe limits by a shocking 28.6%! This toxic substance can be fatal when consumed and poses serious risks, especially for children. Risks: Abdominal pain, vomiting, diarrhoea, altered mental state, and acute kidney injury leading to death. ...

WHO: Rubella Triumph in South-Asia

Some good news: In just a few years, the WHO South-Asia Region has made incredible strides in controlling rubella. Vaccine coverage has skyrocketed from 12% to 86%, cases have dropped from 5.5 to 1.1 per million, and elimination has been achieved in the Maldives and Sri Lanka. Let’s celebrate this tremendous progress together! For more information ...

WHO Issues Medical Product Alert Regarding Substandard Syrup Medicine

Attention to all. WHO has issued a Medical Product Alert N°4/2023 regarding substandard (contaminated) syrup medicines CRM:0557513. Please check out the WHO website in all 6 UN languages for more information and forward this to relevant end-users, National Regulatory Authorities, procurers, and any other relevant colleagues and organizations. WHO urges increased scrutiny of these products. ...

Health Alert: Falsified DEFITELIO Batch Lacks Active Ingredients

WHO warns of falsified DEFITELIO batch containing NO active ingredients. This could lead to ineffective treatment and serious health risks, including life-threatening situations. Please see the attached alert and do not hesitate to share it with anybody potentially interested/concerned.

WHO Advisory Group on Blood Regulation, Availability and Safety (AG-BRAS)

Our regulatory expert Ms Linda Mudyiwenyama who is supporting the Rwanda FDA has participated in the first face-to-face meeting of the WHO Advisory Group on Blood Regulation, Availability and Safety (AG-BRAS) held at WHO headquarters, Geneva, Switzerland on March 7-8, 2023. The Advisory Group functions to support programs and activities in blood regulation and transfusion ...

WHO French version of TRS1025 & TRS961

The World Health Organization (WHO) GSDP (Good Storage and Distribution Practices) standards (Annex 7 – TRS 1025 – Good storage and distribution practices for medical products ) published in 06/2020 is now available in French on the link Bonnes pratiques de stockage et de distribution des produits médicaux, as well as the “WHO Model guidance ...

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