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HSA Achieves WHO ML4 Recognition for Medical Devices, Expands Biomedical Role

The Health Sciences Authority (HSA) in Singapore has achieved the highest World Health Organization (WHO) Maturity Level (ML4) for medical devices regulatory systems, becoming the first national authority globally to do so. HSA is also expanding its economic role to support the biomedical sector's growth.

Raymond Chua's address at 29th Medical Device Regulators Forum

Raymond Chua's address at 29th Medical Device Regulators Forum

HSA Deepens International Partnerships for Biomedical Sector Growth

The Health Sciences Authority (HSA) of Singapore has announced deepened collaborations with Malaysia and Uzbekistan to facilitate access to medicines and medical devices. These partnerships include a formalised Medical Device Regulatory Reliance Programme with Malaysia and a Memorandum of Understanding with Uzbekistan for broader regulatory cooperation.

TGA Safety Advisory: Counterfeit GLP-1 Weight Loss Products

The Therapeutic Goods Administration (TGA) has issued an updated safety advisory regarding counterfeit weight loss products falsely claiming to contain GLP-1 receptor agonists. Laboratory testing confirmed these products contain no active GLP-1 ingredients and are not included in the Australian Register of Therapeutic Goods.

TGA Safety Alert: Natures Valley Collagen Builder contains undeclared sildenafil

The Therapeutic Goods Administration (TGA) has issued a safety alert regarding Natures Valley Collagen Builder tablets, which were found to contain undeclared sildenafil. Consumers are warned that the product poses a serious health risk and should not be taken.

Safety Concerns Over Imported Counterfeit Melatonin Products

The Therapeutic Goods Administration (TGA) has issued a safety advisory regarding imported counterfeit unregistered melatonin products. Laboratory testing revealed significant discrepancies in melatonin content, with some products containing over 400% of the labelled amount and others none at all, posing serious risks to consumers, especially children.

TGA Safety Alert: Ayurvedic Tablets Contain High Heavy Metals

The Therapeutic Goods Administration (TGA) has issued a safety alert regarding Kumar Kalyan Rasa tablets, an Ayurvedic medicine. Testing revealed extremely high concentrations of heavy metals, including mercury, lead, arsenic, and cadmium, posing serious health risks to consumers, particularly pregnant women and children. The TGA urges consumers to exercise extreme caution with such products.

TGA Safety Alert: Counterfeit Botox Vials Continue to be Imported

The Therapeutic Goods Administration (TGA) has issued a safety advisory regarding the continued importation of counterfeit Botox vials into Australia. These products, packaged to appear genuine but confirmed as fake by AbbVie, pose significant public health risks and cannot be legally imported under any circumstances.

Voxzogo (vosoritidum) Packaging Text Error Identified

Swissmedic has identified a packaging text error on Voxzogo (vosoritidum) outer packaging. The incorrect dosage information was printed on specific batches, and affected batches have been identified. The company has issued an information letter detailing the error and corrective actions.

Keppra (Levetiracetam) Syringe Change and Medication Error Risk

Swissmedic and UCB-Pharma AG are issuing a communication regarding a change in the application syringe for Keppra (Levetiracetam) oral solution. A new 5 ml syringe replaces the 3 ml syringe for children aged 6 months to 4 years, requiring healthcare professionals to inform caregivers about the change and proper dosing to prevent medication errors.