
SFDA hosts their 1st meeting of Arab Authorities Controlling Medicines, promoting Arab integration in the field of medicines control and legislation. Topics discussed included registration procedures, monitoring safety and quality, and the role of medicines control labs. Coordination and alignment with legal and regulatory requirements for medicines are key to facilitating availability and lowering costs for patients.
Recent Posts
Strengthening Supply Chains: The EU Critical Medicines Act
The European Medicines Agency (EMA) has welcomed the provisional political agreement on the EU Critical Medicines Act, an initiative designed to enhance the availability, production, and supply of critical medicines throughout the European Union. This agreement represents a key a...
Marstacimab Cost-Effectiveness Analysis in Hemophilia Treatment: A Portuguese Assessment
The public assessment report for Hympavzi (marstacimab) in Portugal concludes that the product offers no added therapeutic value relative to recombinant factor VIII concentrates and emicizumab in patients aged 12 years and older weighing at least 35 kg with severe hemophilia A without factor VIII...
Overcoming Challenges in Managed Entry Agreements for ATMPs
Decision-makers in England, the Netherlands, and Spain consistently identify administrative burden, outcome measurement, and data collection as the foremost obstacles to adopting managed entry agreements ATMPs. These challenges emerge most acutely when hybrid or outcome-based agreements are consi...