Malta’s small market is creating unique regulatory challenges for the pharmaceutical sector, The Malta Business Weekly has been told.
The pharmaceutical industry is often associated with innovation, research, and commercial strategy. The industry, however, also acts as an effective gatekeeper of patient access, ensuring that medicines are not only effective but also lawful, traceable, and safe.
“Regulatory Affairs and Quality function quietly behind the scenes, but are fundamental to every stage of a product’s lifecycle and without them, no health product would reach the market legally, safely, or efficiently,” explains Corinne Zaffarese Elbourne, Regulatory Affairs and Quality Unit Manager at Vivian.
Zaffarese Elbourne says that in the increasingly complex and regulated pharma sector, regulatory affairs and quality management remain the unsung heroes – often overlooked yet essential – quietly ensuring every medication meets strict compliance, documentation, and ethical standards.
“Aspects related to regulation and quality often do not make headlines, but they hold the keys to timely and safe access to treatment,” she says, pointing out how in Malta, where the pharmaceutical market is defined by its small size and unique logistical challenges, the regulatory function takes on a heightened level of importance.
“It’s not just about ticking boxes but about bridging gaps. From managing emergency product launches to facilitating access to treatments not marketed locally. We often operate by balancing urgency, bureaucracy, and innovation.”
Zaffarese Elbourne describes her unit as both “a gatekeeper and a strategic enabler” responsible for ensuring compliance while pushing through time-sensitive solutions whilst ensuring conformity with EU frameworks and coordinating with local authorities.
“This positions our role as crucial in preventing out-of-stock situations and accelerating access to critical therapies. I recall one particular instance where we secured a life-saving medication, collected it directly from the airport, released it during the night, and personally delivered it to the hospital to ensure timely patient access.”
“These high-stakes situations are not so common but when they happen, they underscore the real-world impact of regulatory agility.”
Balancing compliance with accessibility however is no easy feat. EU legislation provides a harmonised regulatory structure, but local implementation often adds layers of specificity. “In Malta, this can mean reconciling different documentation standards or aligning labelling requirements with national language and legal frameworks. This is why proactive communication with both authorities and suppliers is key. Our goal is always to ensure compliance without compromising patient access,” she adds.
“This balancing act becomes even more nuanced when dealing with innovative or treatments for rare diseases. Here, regulatory teams often turn to special access schemes such as compassionate use or Named Patient Basis, mechanisms that require deep expertise and strong relationships with healthcare providers and government bodies,” she adds.
Beyond getting products to market, another key responsibility falls under the regulatory umbrella: pharmacovigilance which she describes not only as a legal requirement but a moral one, ensuring that potential safety signals are detected early and acted upon appropriately.
“It’s a responsibility we take very seriously,” she says, noting that training, vigilance, and strong internal systems are essential.
The emphasis on regulatory preparedness is even more pressing in a post-pandemic world, where supply chain disruptions have made it essential to plan proactively and build regulatory flexibility into our processes. These challenges have prompted regulatory teams to employ contingency planning, early communication with authorities and carry out batch checks at the earliest possible phase to avoid delays.
But as the industry becomes more globalised, cross-border collaboration is essential. Maintaining alignment with international players like Pfizer requires us to align with international regulatory and quality standards while also tailoring our approach to the Maltese context. “Regulatory leaders must act as translators by adapting global expectations to local realities. This requires excellent communication and mutual understanding of each party’s compliance frameworks.”
“And for a smaller market like Malta this global interconnectedness offers a key advantage as it allows us to leverage international regulatory decisions and data to accelerate access to essential and innovative treatments,” Zaffarese Elbourne adds.
The role of regulatory affairs is also evolving rapidly, shaped by digitalisation and the increasing use of real-world evidence.
“Electronic submissions have improved speed and transparency, while post-market surveillance now often includes patient-reported outcomes and population-level data.”
Looking ahead, Zaffarese Elbourne sees the field becoming more integrated and strategic. “It isn’t just about compliance. Regulatory Affairs shapes access strategies, influence health outcomes, and anticipate global trends.”
Indeed, as regulators themselves shift toward adaptive licensing models and faster approval pathways, particularly for breakthrough therapies, the function is transitioning from gatekeeping to enabling.
“This evolution reflects a broader trend in healthcare where agility, collaboration, and real-world impact are no longer optional.”
“Regulatory decisions can ripple across countries and continents; therefore, the future of pharmaceutical access will depend on how well these behind-the-scenes teams can stay connected, informed, and responsive. For smaller nations like Malta, this global interconnectedness is not a threat but a strategic advantage. Technology and international collaboration also enable earlier access to treatments that might otherwise have been deprioritised.”
“Our regulatory work may appear procedural, but behind every barcoded box in a pharmacy lies a chain of decisions, risks, and responsibilities. Our work is never in the spotlight, but it’s there every time a patient starts a new course of treatment,” she concluded.
