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11

Mar

EMA outlines methods for evaluating supply chain vulnerabilities

The European Medicines Agency (EMA) has published a document detailing its methodology for monitoring potential vulnerabilities in the medicine supply chains. The agency said its new framework is intended to prevent potential shortages of drugs considered especially important on the Union List of Critical Medicines (ULCM).
 
On 10 March, EMA published the document that was originally adopted by its Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) on 17 November 2025. The agency said the methodology is intended to be practical and implementable, while avoiding duplication of existing processes and taking on unnecessary burdens...[EMA]

23

Apr

Top Drugs at Risk of Supply Shortages

Nearly half of 100 vulnerable medicines have at least one key starting material sourced exclusively...

23

Apr

Regulatory considerations for pharmaceutical excipient selection

The article discusses the role and importance of excipients in medicines, focusing on regulatory aspects...

21

Apr

TGA clarifies therapeutic goods are unaffected by chemical production and import ban

TGA has clarified the impact of Australia’s industrial chemicals standards on medicines, medical...

20

Apr

US FDA Draft Guidance on Establishing Impurity Specifications for Antibiotics

FDA issued the draft guidance for industry, Establishing Impurity Specifications for Antibiotics. This...

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