https://www.um.edu.mt/library/oar/handle/123456789/478 Wed, 30 Sep 2026 19:11:06 GMT 2026-09-30T19:11:06Z https://www.um.edu.mt/library/oar/handle/123456789/149539 Title: Implementing regulatory flexibilities to enhance compliance and patient access : a practice-based initiative Authors: Calleja, Jean Claude; Langaro, Marina; Muscat, Caroline; Serracino-Inglott, Anthony Abstract: Background: Regulatory frameworks serve an essential role to safeguard public health, notwithstanding this, they may hinder timely access to pharmaceutical care and create additional administrative burden for pharmacists. During routine inspections of community and hospital pharmacies in Malta, several recurring operational challenges were identified that contributed to inefficiencies in service delivery and documentation processes. In response, the Malta Medicines Authority (MMA) sought to introduce proportionate regulatory flexibilities that maintained compliance while supporting pharmacists in delivering efficient and patient‑centred services. The aim of this study is to develop, validate and implement regulatory flexibilities which may reduce administrative burden for pharmacists and improve timely access to pharmaceutical care. Method: Regulatory flexibilities were identified through a combined approach involving a review of relevant legislation, regulatory guidance and international best practices, together with insights gathered during routine pharmacy inspections conducted by MMA inspectors. A focus group discussion consisting of a Pharmacist, Pharmacy Inspector, Senior head of pharmacy inspections and the director was held to assess regulatory soundness, risk implications, feasibility of implementation and to evaluate their potential impact on patient safety, compliance and operational efficiency. Regulatory flexibilities demonstrated through evaluation to yield a positive impact were formally adopted and incorporated into subsequent inspection cycles. Implementation was monitored through inspectors’ feedback, follow‑up inspections and ongoing communication with pharmacists to ensure consistency, clarity and continued adherence to regulatory standards. Results: Five (5) regulatory flexibilities were implemented to streamline processes and support pharmacists in meeting compliance requirements. First, the use of online sources in place of printed physical copies was permitted, enabling timely access to up-to-date reference information and reducing the need for maintaining extensive printed materials. Second, statutory registers were allowed to be stored in secure online formats, improving accessibility, reducing physical storage demands and supporting more efficient record management. Third, a standardised process for the disposal of Dangerous Drug of Abuse (DDAs) was developed to ensure safe and consistent handling of DDAs across pharmacy settings. Fourth, the use of photographs of prescriptions for the daily register was authorised, allowing accurate documentation while reducing administrative workload and minimising transcription errors. Finally, the storage of medicinal products within doctors’ clinics was permitted, if products were kept under lock and key and secured from unauthorised access. Collectively, these flexibilities reduced administrative burden and improved workflow efficiency. Inspectors reported fewer recurrent non‑compliances and pharmacists noted improved practicality in meeting regulatory expectations. No safety concerns or adverse regulatory outcomes were observed following implementation. Conclusion: The introduction of targeted regulatory flexibilities demonstrated that regulatory systems may remain robust while adapting to operational realities in pharmacy practice. These measures supported improved compliance, reduced bureaucratic burden and facilitated more efficient patient access to pharmaceutical care. Continued evaluation will assess the long‑term impact of these flexibilities and identify further opportunities to optimise regulatory processes within the regulatory framework. Thu, 01 Jan 2026 00:00:00 GMT https://www.um.edu.mt/library/oar/handle/123456789/149539 2026-01-01T00:00:00Z https://www.um.edu.mt/library/oar/handle/123456789/149533 Title: The reform of the European Union pharmaceutical legislation Authors: Mirzayeva, Fidan; Anastasi, Alison; Serracino-Inglott, Anthony Abstract: Background: The European Union is reforming its pharmaceutical legislation to improve medicine availability, reduce delays in access, strengthen shortages governance, and realign innovation incentives. This is important because the EU marketing authorisation system has not ensured equitable access across Member States. Persistent inequalities remain after authorisation, when manufacturer launch decisions interact with national pricing, reimbursement, procurement, and administrative capacity. These challenges are particularly evident in smaller markets, such as Malta, where commercial incentives are weaker and administrative capacity is more limited. This study assessed whether the proposed reform contains implementable mechanisms capable of reducing inequalities in availability, speed of access, affordability, and supply resilience, and compared the reform with approaches in the United States and Türkiye. Method: A qualitative comparative design combined documentary analysis with expert stakeholder evidence. European Union draft legislation and the December 2025 political compromise were analysed alongside primary regulatory and policy documents from the United States and Türkiye and relevant peer-reviewed literature. Findings were translated into an eight-theme discussion guide, piloted in one focus group, and applied in a second expert focus group. Two stakeholder sessions were analysed as one dataset of ten participants, including regulatory, legal, procurement, and supply-facing perspectives. Sessions were recorded, transcribed, and analysed using framework analysis, and findings were integrated using a strengths, weaknesses, opportunities, and threats approach. Results: Triangulated findings identified a consistent pattern. The reform was found to be strongest in structured governance tools, particularly shortage prevention plans, critical medicines monitoring, and support for earlier generic and biosimilar entry. Under the political compromise, central scientific assessment would fall from 210 to 180 days, while protection would become eight years of data protection plus one year of market protection, with capped extensions. Its main implementation weakness was access-linked conditionality, as launch, sufficient supply, and continuous availability were difficult to define and verify across Member States. Comparative analysis further showed that, in the United States, litigation architecture and enforceable shortage-reporting deadlines shape competition and supply, while, in Türkiye, pricing rules, exchange-rate mechanisms, and pack-level traceability influence launch incentives and post-authorisation continuity. In the expert group, five of ten stakeholders reported familiarity (mean scores 3.30/5; range 2.75-4.00). The conditions with regards to the launch and supply of medicines in the reform (Article 82) attracted the strongest scepticism: four of ten stakeholders considered it unworkable, one expressed a conditional view, and one rated its workability one out of five. Shortage governance and critical medicines tools received the strongest support, with two of ten stakeholders agreeing and two expressing conditional views. Conclusion: The proposed reform introduces credible governance innovations, but reducing access inequalities will depend more on operational definitions, evidence standards, and administrative capacity than on legislative ambition. Shorter authorisation timelines alone are unlikely to narrow inequalities arising after authorisation. For smaller markets, success will depend on whether final rules are measurable, enforceable, and workable across national access pathways. Thu, 01 Jan 2026 00:00:00 GMT https://www.um.edu.mt/library/oar/handle/123456789/149533 2026-01-01T00:00:00Z https://www.um.edu.mt/library/oar/handle/123456789/149532 Title: Assessing the feasibility of manufacturing sites for remote good manufacturing practice inspection Authors: Farrugia, Stefanie; Sammut Bartolo, Nicolette; Serracino-Inglott, Anthony Abstract: Background: The COVID-19 pandemic caused unprecedented disruption to traditional on-site regulatory inspection models due to travel restrictions. In response, regulatory authorities rapidly implemented remote inspection methodologies using digital technologies as one of the mitigation measures. While these approaches proved valuable, their application was often ad hoc, with limited structure or harmonised criteria guiding when remote inspections were appropriate. The absence of a standardised framework risked inconsistency in regulatory decision-making and potential variability in inspection outcomes. This study aimed to develop a structured, risk-based assessment tool to support competent authorities in determining the feasibility and appropriateness of conducting remote Good Manufacturing Inspections (GMP) while maintaining confidence in regulatory oversight. Method: The risk assessment tool was developed through a comprehensive literature review and stakeholder engagement. Existing regulatory guidance, published studies, and inspection practices were analysed to identify key risk factors influencing remote inspection feasibility. In parallel, feedback was collected through a structured questionnaire distributed to regulatory and industry experts. The tool was designed to evaluate whether a remote inspection could provide a level of assurance comparable to an on-site inspection. Key considerations included the robustness of IT infrastructure, data accessibility and integrity, site complexity, and prior knowledge of the manufacturing facility from previous inspections or regulatory interactions. Results: A semi-quantitative risk assessment tool was developed and subsequently validated by two independent expert groups. The tool comprises eight domains, each containing four indicators, resulting in a total of 32 criteria for assessment. The domains include: product and patient risk; GMP compliance history; inspection and regulatory background; manufacturing and process complexity; quality management system maturity; change management and external signals; data integrity and computerized systems; and technical feasibility for remote inspection. Each indicator is assigned a score of 1, 3, or 5, with higher scores representing greater risk severity. Domain-specific weightings are applied to reflect their relative importance, and weighted scores are calculated for each domain. These are then aggregated to produce an overall risk score. The final score is categorised into three ranges: low risk, where remote inspection is considered appropriate; medium risk, where remote inspection may be conditionally appropriate; and high risk, where an on-site inspection is recommended. The tool demonstrated consistency and usability across expert groups, supporting its potential application in regulatory settings. Conclusion: The COVID-19 pandemic demonstrated that digital technologies can effectively support continuity of regulatory oversight; however, remote inspections cannot fully replicate the depth of insight, contextual understanding, and trust established through on-site inspections. The proposed risk assessment tool introduces a structured and harmonised approach to decision-making, enabling competent authorities to assess the suitability of remote inspections in a consistent and transparent manner. While remote methodologies offer advantages, particularly in situations where physical access is restricted, challenges related to technology, cybersecurity, human factors, and limitations in observing non-verbal cues remain. Future work should focus on refining remote inspection frameworks, enhancing digital infrastructure, and integrating hybrid inspection models, ensuring that innovation complements rather than compromises the rigour and reliability of established regulatory practices. Thu, 01 Jan 2026 00:00:00 GMT https://www.um.edu.mt/library/oar/handle/123456789/149532 2026-01-01T00:00:00Z https://www.um.edu.mt/library/oar/handle/123456789/149528 Title: Development of a novel terminological framework for quality assurance signal management in pharmaceutical regulatory systems Authors: Sammut, Valentina; Grech, Louise; Serracino-Inglott, Anthony Abstract: Background: The evolving complexity of pharmaceutical regulatory systems has diversified the compilation of data, yet to date the systematic management of quality assurance (QA) signals remains conceptually and methodologically underdeveloped. In contrast to pharmacovigilance, where signal management is underpinned by well-established terminologies, taxonomies, and analytical methodologies, QA signal management remains unexplored within existing regulatory, quality management, and scientific lexicons. The absence of terminological constructs contributes to interpretative variability, limits methodological harmonisation, and impedes the advancement of quality assurance signal assessment within pharmaceutical regulatory sciences. Addressing this gap, the study introduces a novel glossary framework intended to provide definitional clarity, conceptual consistency, and terminological traceability in the management of QA signals. The framework aims to characterise identified QA signals and support a structured conceptual lexicon to sustain the systematic identification, interpretation and application within a pharmaceutical regulatory context. Method: An inductive-interpretative analytical approach informed the development of a terminological glossary framework. The terminological constructs were derived from the iterative application of the Quality Assurance Signal Analytical Framework to dataset sources, namely quality improvement forms submitted at the Quality, Continuous Improvement and Internal Audits Unit at the Malta Medicines Authority. The approach involved iterative rounds of QA signal data analysis, signal-to-principle mapping, and thematic clustering. The framework was validated through a structured expert focus group (N=7) consultation. The criteria of the glossary framework were evaluated using the Content Validity Method to assess clarity, relevance, and structure and layout. Suggestions and recommendations made during the validation process informed the development of the framework to achieve conceptual clarity and linguistic precision. Results: The glossary framework incorporates a foundational knowledge-building element required to support the application of quality assurance signal intellect. The glossary is presented in a structured tabular format comprising three core criteria: (i) terminological -omics constructs, (ii) conceptual definitions, and (iii) scientific rationales. Analysis indicated that QA signals arose not solely from discrete quality assurance practices but from multidimensional dynamics spanning across governance-associated influences, integrative system interactions, organisational capability and resources-related dynamics, and stakeholder-driven outcomes. To capture these multidimensional QA signal origins, four novel terminological constructs were developed. ‘Governomics’ characterises governance-related signals reflected through the evaluation of the quality management system documentation framework and procedural consistency. ‘Integromics’ reflects interdependencies across quality management systems, operational interfaces, and process integration performances. ‘Capacitomics’ represents organisational capacity-related QA signals, including resource allocation, workforce competencies, infrastructure adequacy, and system maturity. ‘Stakeholderomics’ encompasses behavioural, cultural, communication, and inter-stakeholder interaction. Collectively, the four terminological constructs provide a structured taxonomy enabling consistent classification and interpretation of QA signals. Conclusion: The glossary framework is envisioned as a dynamic conceptual tool intended to focus on a shared scientific understanding amongst quality management and pharmaceutical regulatory professionals. The introduction of a validated QA terminological construct grouping supports the invention of QA intelligence and provides a foundation for future methodological development, professional competency development, and evidence-based decisionmaking. The evolvement and integration of the framework represent a pioneering advancement towards the development of a structured lexicon for QA signal management within medicinal products regulatory sciences. Thu, 01 Jan 2026 00:00:00 GMT https://www.um.edu.mt/library/oar/handle/123456789/149528 2026-01-01T00:00:00Z