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.

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The signing was presided over by Health Minister Jo Etienne Abela in Rome, Italy.

A government statement on Tuesday said that the agreement aims to enhance cooperation between Malta and Italy to achieve shared goals in European pharmaceutical policy and beyond.

It said that this agreement not only reaffirms the strong bond between the two nations but also underscores Malta’s commitment to collaboration within the EU and, most importantly, to improving healthcare for its patients.

Abela said that the purpose of this agreement is to reinforce the role of Italy and Malta as key partners in implementing European pharmaceutical policy.

“At the same time, we seek to improve the security and accessibility of medicines while promoting innovation and sustainability across the Mediterranean and the European Union,” Abela said.

He continued that this agreement will ensure that both countries benefit from the exchange of information and best practices in regulatory sciences.

It will also encourage the adoption of innovative methodologies, including digitalization, regulatory automation, and artificial intelligence, to improve regulatory decision-making and efficiency.

Additionally, the agreement will foster joint efforts in international cooperation initiatives, enhance resilience against health emergencies, and strengthen operational capacities while expanding the expertise of employees.

Abela said that this agreement will provide an opportunity for both countries to continue advancing pharmaceutical regulatory science.

“It is essential that Malta and Italy benefit from a collaboration whose primary goal is to better serve our patients,” Abela said.

During his visit to Rome, Abela also met with Italian Minister of Health Orazio Schillaci.

The statement said that their discussions covered further collaborations between Malta and Italy on medicine accessibility, transplants, screening, blood transfusions, and training for healthcare professionals.

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“This strategic expansion, which adds 1,800m² of additional warehousing space, enables us to meet our increased storage demands while enhancing our service offerings by providing warehousing solutions for third-party clients,” Gatt added.

The new facility is built to meet the strict storage and regulatory standards of the pharmaceutical industry. It is designed with flexibility in mind, offering ample space to meet various storage needs, including high or low pallets, batch samples, and products, with a customizable layout to suit specific requirements.

“We invite pharmaceutical companies, distributors, and related businesses to explore the leasing opportunities at our new warehouse,” concluded Matthew Gatt.

For more information or to arrange a tour of the facility, please contact Mint Health at info@mint.com.mt.

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Prohealth, which commenced its journey in 1995, has consistently demonstrated a commitment to growth and excellence. Over the years, it has not only solidified its presence in the pharmaceutical and dermo-cosmetic markets in Malta & Libya but it has strengthened its presence in the medical devices market, leading to the recent acquisition of TrioMed Ltd, a leader in medical equipment and digital health technology, and in the Government Pharmaceutical Tender Business.

This new chapter with Nestlé Malta is led by Steven Ellul, Prohealth’s Pharma Business Development Manager, and Brand Manager Gaby Sultana. Together with Nestlé Malta’s Category Management Team, Christian Cachia & Tatiana Negrini they have embarked on a rigorous training program, ensuring a deep understanding of the product range to effectively communicate the benefits to healthcare specialists and customers.

“This prestigious partnership with Nestlé, significantly enlarges Prohealth’s footprint in the fast-growing Nutrition category in Pharmacies, in-line with our 2025 vision objectives. We are firmly committed to develop further, the current Nestle’ Infant Nutrition and Health Science brands portfolio. At the same time, we look forward to establishing exciting, new Nestle’ Health Science brands locally, enabling patients and customers to benefit from the power of nutrition these brands offer at every life stage, from birth to healthy ageing,” said Peter Apap, Prohealth’s CEO.

Prohealth’s ongoing efforts to train and empower its team of medical representatives and brand specialists further illustrate its commitment to excellence. By equipping its team with extensive knowledge and skills, Prohealth ensures that it remains at the forefront of delivering advanced healthcare solutions and services to its customers and the broader community.

For more information contact on info@prohealthmalta.com or visit www.prohealth.com.mt

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“Our strong pharmaceutical industry continues to be an important pillar in Malta’s economy, and we are proud that Vivian continues to be an important player in this fast-growing pharmaceutical sector,” said Denise Borg Manche, Managing Director of Vivian.

“Our company’s growth as a holistic provider of healthcare has allowed us to invest in our newly built premises and a fully licensed warehousing facility for the storage and distribution of pharmaceutical products,” added Ms Borg Manche.

Vivian’s substantial investment in its new head offices which are now located in Marsa, has enabled the company to centralise its operations, strengthen its work in the distribution, marketing and promotion of pharmaceuticals, medical devices and nutraceuticals and develop new service areas such as pharmaceutical warehousing for the storage and distribution of pharmaceutical products.

The premises, in fact, include a new 1,000m² temperature-controlled warehouse facility that not only caters for Vivian’s products but can now also accommodate pharma warehousing for third-party clients.

The new offices also include a dedicated space for Vivian’s recently set up Vivian Academy which will be hosting training and engagement with the company’s wide stakeholder ecosystem.

“This new investment not only has allowed us to redefine who we are and what we stand for but also to position ourselves to service our clients and stakeholders better so that we can continue delivering the highest levels of healthcare products and services to all our communities,” concluded Denise Borg Manche.

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The investment began in 2020, with €20 million being invested by the end of this year, and a further €11 million is planned next year.

Teva Pharmaceutical Industries has been developing and producing medicine for over a century. Teva Malta currently produces 2.2 billion tablets a year, which are approved by the Maltese Medicines Authority and other regulatory authorities.

“The root of what Teva Malta is today trace back to 1976, and today consists of state-of-the-art bulk manufacturing and packaging facilities, warehouses, and testing laboratories which are maintained to the highest standards. The site became part of Teva Pharmaceutical Industries in 2016,” managing director Patrick Cachia said

This announcement was made during a visit today by Prime Minister Robert Abela. During his visit, he praised the company and the hard-working professionals for the work that they do.

Minister for Environment, Energy and Enterprise Miriam Dalli and Minister for Economy and Industry Silvio Schembri were also present during the visit.

Abela pointed out how this global company reaches out to 200 million patients around the world and called this a demonstration of confidence in Malta’s talent and economy.

“This investment is the result of a strong economy and an ecosystem that gives business confidence to invest and grow,” Abela said.

“The forecasts of the European Commission and the reports of international credit agencies are giving a clear message that the way we are protecting people and keeping energy and fuel prices stable is will have a positive effect on Maltese businesses,” Abela said.

Abela also noted that there are many fruitful opportunities for students who have graduated.

He also praised the company for following Environmental, Sustainable and Governance (ESG) practices.

Cachia said that this investment will continue to strengthen all the current facilities and upcoming projects.

“This is also possible thanks to the constant support of Malta Enterprise, INDIS and the Medicines Authority throughout these years, especially during the pandemic, and also in terms of training assistance to upskill more employees,” he said.

Cachia said that this investment will also help Teva Malta employ an additional 70 people, to add to the 430 employees. This will work well with the company’s recent move towards a 24/7 shift operation.

“Central to these successes are Teva Malta’s employees. The company recognises that its employees are the greatest asset, and as such it demonstrates a critical focus on employee well-being, inclusion and diversity. This has been recognised by the Foundation for Human Resource Development, which awarded Teva with the HR quality Mark for high employee-focused standards within the company. Malta is also committed to equality and diversity, with its senior leadership team split evenly between both genders, and 14 per cent of employees hailing from other various nationalities,” Cachia said.

Cachia said that so far the investments have contributed to a new purified water system, a full fabric upgrade of three granulation bays, tooling for new product introduction, new chillers, compressors and house vacuum transfer systems to assist employee protection.

Cachia also said that Teva Malta has invested heavily in future-proof IT Enterprise transformation.

For this coming year, among others, Teva Malta will invest in new production equipment, and new tooling to allow new product introduction and the extension of a laboratory.

Cachia also praised the intervention of the government to keep the price of electricity stable which was crucial for Teva Malta to maintain its competitiveness.

Cachia added that the company has also introduced a number of energy reduction initiatives including the installation of more than 700 LED lighting units, the planned installation of 1,328 photovoltaic panels, new more efficient HVAC systems, and the elimination of two diesel fuelled steam boilers. This has reduced electricity consumption equivalent to 6,000 houses in Malta annually.

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That was the main conclusion of a seminar organised by Malta’s fastest-growing science company, Evolve.

The well-attended event was held at Villa Bighi in Kalkara, as part of Evolve’s ongoing Customer Educational Programme with SOTAX, the world’s leading solution provider for pharmaceutical test equipment.

Its purpose was to discuss the latest important advances in the sector, examining ways to accelerate drug development, embrace cutting-edge pharmaceutical technologies, and devise more efficient forms of drug production.

In recent years, pharma businesses based in Malta have started to utilise digitalisation, automation, and other technical and industrial developments, but some still have a way to go.

The list of speakers was led by Ramsey Khinda, head of sales and marketing for Europe at SOTAX.

Speaking afterwards, he said: ‘It was an excellent seminar with great participation from the delegates, wanting to know more on automated platforms for productivity and compliance.’

The meeting heard how new technologies are being introduced at a rapid rate. Innovations in automation, digitalisation, production systems, and testing methods require pharma companies in Malta to recruit new talent and nuture external collaborations and strategic partnerships.

The event also examined the advantages automation can bring to quality control laboratories, such as cost savings, better accuracy, more traceability and enhanced compliance to pharma regulations.

One of the highlights of the afternoon session was an open discussion where attendees discussed the hurdles and remedies in making the switch from manual operation to automated systems.

Other speakers included Tobias Tielke, the product manager of physical testing at SOTAX, and Godfrey Agius, a specialist in quality control at Aurobindo Pharma, based in Hal Far.

Evolve business account manager Zachary Muscat, who chaired the event, said: ‘The success of our event at Villa Bighi shows that our partnership with SOTAX is already benefitting the wider science sector in Malta.

‘SOTAX is a world-class leader in physical testing equipment and fits in with our portfolio at Evolve perfectly. Together Evolve and SOTAX will continue to offer our know-how as a service to the pharmaceutical industry in Malta.

‘A huge thanks to everyone who took part in our latest seminar. We had some great conversations and it was good to catch up with our customers, friends and partners in the Maltese pharmaceutical industry.’

Evolve, based in Luqa, is Malta’s fastest-growing science company for laboratory design services, high quality lab supplies and chemicals, as well as specialist scientific and medical equipment.

International customers include major pharmaceutical companies, medical cannabis firms, hospitals, schools, universities, public laboratories and the oil and gas sectors.

The post Evolve hosts pharmaceutical seminar in Malta first appeared on The Malta Business Weekly.

Recruitment has been a challenge for many industries in recent years, not least the pharmaceutical one where a shortage of key scientific and medical skills has been keenly felt. Adapting to this reality has not come easy for many in our industry which, understandably, has a culture of acting only after considerable and thorough research and consideration. That said, at Pharmacare Premium we have implemented several policies that have helped us to successfully navigate this challenging labour market and are confident we now have the human resource structures in place to ensure the continued growth of our business.

A key principle guiding our approach is that quality depends on diversity. Even though our business is driven by scientific research, different cultural, academic and professional backgrounds do bring with them a multitude of different viewpoints. This diversity is incredibly valuable when it comes to developing and testing new ideas. The challenge, of course, is to harness that diversity positively and effectively. While empowering all our employees to share ideas and knowledge is important, it is not enough to guarantee success.

Arriving at where we are now, after more than a decade of running our EU-GMP-approved modern facility in Ħal Far, Pharmacare has proactively invested time and resources into increasing the expertise and professional knowledge of our workforce. Today, our state-of-the-art infrastructure and high-end equipment are coupled by an engaged labour pool supported by a dedicated managerial team empowering collaborative decision-making. This unique combination allows us to research, develop and “stock and pile” generic, high-potency products. Our European Medicines Authority (EMA) approved plant is suitable for the high-potency “contained production” of value-added, therapeutic products, of which we have a reliable supply to not only markets in the European Union but also internationally.

As we strive to reach optimum performance in our scientific medical work, which has a direct and long-lasting impact on the health and well-being of our communities, we recognise the need to support our employees on both professional and personal levels to ensure that our people fulfill their career potential. As communication is crucial in any job, especially in an inclusive and diverse environment, Pharmacare Premium provides our staff with business language courses to ensure that all our employees can fully participate in the exchange of information.

Additionally, where available, we provide access to specialised, appropriate training to ensure that our experts’ knowledge is up-to-date in order to meet swiftly-changing market requirements. Nevertheless, as a healthy work-life balance is a prerequisite for professional and personal satisfaction, we have organised regular team-building and social events to assist our employees integrate with the communities and cultures that surround them.

As the world of work changes rapidly, it is safe to say that the importance of lifelong learning will only increase. To help all our employees from recent graduates to experienced senior managers, Pharmacare Premium has been establishing synergies with educational institutions, both vocational schools and universities, to support teachers and lecturers with educating the experts of the future. In the framework of such arrangements, we also welcome students to our company for internships to provide them with the hands-on experience that helps them deepen their knowledge.

These concerted efforts give Pharmacare Premium Malta the momentum to become a quality centre of excellence for the Pharmacare family of companies, paving the way for us to join the leading pharmaceutical companies in the Mediterranean, the Middle East and North Africa (MENA) regions. As we rigorously commit ourselves to our core values in our daily work, we keep to quality policies and systems, which helps us maintain ourselves as a reliable, specialised supplier of high-quality, niche generic pharmaceuticals for human consumption. 

Laura Thomas is Human Resources lead at Pharmacare Premium

The post Pharma industry adapting to a challenging labour market first appeared on The Malta Business Weekly.

Evolve, based in Luqa, said the deal will further enhance the firm’s already outstanding sales and service offerings to customers in Malta.

SOTAX provides high-quality testing solutions for Research and Development, Quality Control, and In-Process Control departments of the pharmaceutical industry. SOTAX instruments, software, and services are recognised worldwide as the industry benchmark for best-in-class solutions.

Ramsey Khinda, SOTAX Head of Sales and Marketing for Europe, said: ‘It gives me great pleasure to announce that Evolve will be our exclusive sales and service partner in Malta from June 1.

‘I am looking forward to a long-standing relationship, in allowing us to offer the best-in-class solutions for our local pharmceutical customers. Thanks for the warm welcome to Team Evolve this week in Malta.’

Evolve founder and Chief Visionary Officer Christopher Busuttil Delbridge said: ‘Our exclusive agreement with SOTAX is brilliant news not just for Evolve but for the wider science sector in Malta.

‘SOTAX Group is a world-class leader in physical testing equipment and fits in with our portfolio at Evolve perfectly. It has established an excellent international reputation as a specialist in the development and production of sophisticated test equipment and automated systems for pharmaceutical companies.

‘Together Evolve and SOTAX will offer our know-how as a service to the pharmaceutical industry in Malta, including installations, maintenance and repair services as well as a comprehensive and careful validation service.’

SOTAX helps science-led companies worldwide in overcoming the various challenges associated with feasibility studies, method development, method automation, method validation, and method transfer.

Founded in 1973 in Switzerland, SOTAX is a fast-growing group with offices in the USA, Canada, Switzerland, Germany, France, Great Britain, the Czech Republic, India and China. SOTAX also offers technical and analytical services.

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For Cyprus, Ireland and Malta, the rules endorsed by the European Parliament and the Council provide a temporary derogation so that they can continue to source medicines from the United Kingdom only, if needed. The Directive and Regulation apply retroactively from 1 January 2022 and 31 January 2022 respectively.

These proposals were presented by the Commission in December 2021, a statement issued by the European Commission said, after several engagements with many entities representing the both the EU and UK to find a long-term solution. The decision was positively voted in parliament last week.

European commission Vice-President for the Inter- Institutional Relations and foresight, Maros Šefčovič, explained how during his visit to Northern Ireland last autumn, he promised to do whatever it takes to ensure the continued supply of medicines to Northern Ireland.

“We now have a lasting solution, which was delivered in record time. I will continue to work closely with the UK government to ensure predictability, legal certainty, and the prosperity of all communities in Northern Ireland,” he said.

Subsequently the Commissioner for Health and Food Safety, Stella Kyriakides, said that the continuous supply of medicines is important for thousands of “in Northern Ireland – as well as Cyprus*, Ireland and Malta, whose markets are historically dependent on medicines from the UK. We have now fulfilled our commitment to find a solution to ensure that all citizens can continue to get the medicines they need, at all times. I welcome this swift agreement by the European Parliament and Council.”

It is planned that until 31 December 2024, the markets present in Malta, Cyprus and Ireland, will grow stronger and thus decrease their dependency on medicinal products coming from the United Kingdom.

Subsequently the Commission is planning to make proposal to revise the EU’s pharmaceutical legislation, to provide better longer-term structural solutions.

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