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EMA Overview: European Shortages Monitoring Platform (ESMP): How the EU Monitors, Prevents, and Manages Medicine Shortages
Medicine shortages can have a direct and serious impact on patient care, healthcare systems, and public health across Europe. To strengthen coordination, improve visibility, and enable early action, the European Medicines Agency (EMA) has established the European Shortages Monitoring Platform (ESMP) . The ESMP is a central digital platform designed to support the prevention, identification, monitoring, and management of shortages of medicinal products across the EU and EEA.
Sharan Murugan
Dec 20, 20253 min read
EMA Guideline: Quality and Equivalence of Locally Applied, Locally Acting Cutaneous Products
The European Medicines Agency (EMA) recently updated the guideline on "Quality and Equivalence of Locally Applied, Locally Acting...
Sharan Murugan
Oct 6, 20242 min read
New EU Regulations on AI in Medical Devices: Key Insights and Implications
The European Union has published the finalized text of the Artificial Intelligence Act (AIA) which is a significant step forward in...
Sharan Murugan
Jul 15, 20242 min read
Gilead: First Regulatory Approval of HIV Sunlenca® (Lenacapavir) the Only Twice-Yearly HIV Treatment
On 22-August-2022, Sunlenca (lenacapavir) is an injectable HIV medication developed by Gilead Sciences that has been approved to market...
Sharan Murugan
Aug 24, 20221 min read