EXCLUSIVE INTERVIEW WITH PROF ANTHONY SERRACINO- INGLOT. CEO OF MALTA MEDICINES AUTHORITY
“As it navigates the complexities of global health challenges and industry dynamics, the MMA remains dedicated to placing patient welfare at the center of its activities, reinforcing its role as a leader in the pharmaceutical regulatory sphere.”
The Malta Medicines Authority (MMA) has emerged as a pivotal player in the European pharmaceutical sector, showcasing a blend of innovation, expansion, and strategic collaboration. With a proactive approach to regulation and education, the MMA has significantly extended its influence, both within the European Union and globally.
Strategic Expansion and Specialization – Over the past decade, MMA has expanded beyond traditional core areas, adding new directorates focused on advanced scientific initiatives and regulatory science education. This growth enhances MMA’s industry oversight and positions it as a leader in pharmaceutical education and innovation.
Harmonization and Autonomy – MMA plays a critical role in EU regulatory efforts, facilitating harmonized regulations while maintaining jurisdictional autonomy. This balance allows MMA to align with EU standards and respond flexibly to local needs, ensuring it remains a key player in EU and global pharmaceutical regulations.
Global Reach and Recognition – MMA’s impact extends globally, inspecting and certifying pharmaceutical products and production sites worldwide to ensure compliance with EU Good Manufacturing Practices (GMP). These activities uphold high standards within Malta and reinforce the global pharmaceutical supply chain.
Addressing Accessibility and Affordability – MMA has expanded its focus to include the accessibility and cost-effectiveness of medicines, ensuring high-quality medicines are affordable and addressing health equity. This holistic approach prioritizes patient needs alongside efficacy, quality, and safety. This patient centric approach is sustained through the Medicines Intelligence and Access Unit within the MMA.
Facilitating Business and Innovation – MMA supports pharmaceutical companies by fostering a conducive environment for business operations and regulatory affairs. Designation and oversight of notified bodies for medical devices under new EU regulations highlights MMA’s commitment to industry growth. Malta’s efficient regulatory structure attracts pharmaceutical businesses with faster procedural turnarounds.