Licensing Directorate
The Licensing Directorate (LD) is responsible for the regulatory and scientific evaluation related to the registration, life-cycle management and appropriateness of the product information of medicinal products. This includes the reviewing of data in the applications for product authorisation and post-authorisation activities through established National and European procedures in line with the Medicines Act and relevant European Regulations. This ensures that medicinal products placed on the market in Malta and other European countries are of the required quality, safety and efficacy. The Directorate gives the final recommendation to the Licensing Authority (LA) for the granting, variation, renewal, withdrawal, revocation or suspension of licences and authorisations for medicines.
Post-Licensing Directorate
The Post-Licensing Directorate (PLD) is responsible for the continuous monitoring of the safety and quality of medicines after authorisation. This includes overseeing the collection, detection, assessment, monitoring and prevention of adverse effects of medicines; the regulation of advertising of medicines in line with the Medicines Act (Chapter 458 of the Laws of Malta) and its Subsidiary Legislations and the assessment processes for clinical trials.
Inspectorate and Enforcement Directorate
The Inspectorate and Enforcement Directorate (IED) is responsible for Good Practice (GxP) standards are met in the manufacturing and distribution of medicines. Through these include inspections of local wholesale distributors, brokers manufacturers and importers, and the issuance of their GxP/registration certificates, licences, renewals and variations. GMP inspections in 3rd countries are also carried out by the IED, with the aim of issuing an EU-GMP Certificate and supporting renewals and variations accordingly. The Directorate continuously monitors rapid alerts and assesses any quality defects that may arise. It is also within the remit to carry out enforcement activities for medicinal products in line with the Medicines Act (Chapter 458 of the Laws of Malta) and its Subsidiary Legislations.
Advanced Scientific Initiatives Directorate
The Advanced Scientific Initiatives Directorate (ASID) is responsible to establish scientific areas into centres of excellence and manage innovative scientific initiatives in line with the strategy of the Malta Medicines Authority. Advancement of regulatory sciences, encourages research, thought, analysis, dissemination, and innovation in collaboration with relevant local and international stakeholders and contributes to the development of proposals and consolidation of EU expert views on challenging topics including innovative therapies and technologies.
Regulatory Operations, Medicines Intelligence and Access Directorate
The Regulatory Operations, Medicines Intelligence and Access Directorate (ROMAD) steers regulatory operations in line with the strategic priorities of the MMA and spearheads patient-centred regulatory best practices to enhance access to medicines. The Directorate is responsible for pharmaceutical and regulatory operations, capacity building, strategy, communications and public relations, EU and international regulatory affairs, medicines intelligence, access to medicines, human resources and pharmacy practice.
Medical Devices and Pharmaceutical Collaboration Directorate
The Medical Devices and Pharmaceutical Collaboration Directorate is responsible to develop and implement the regulation of Medical Devices (MD) and In-Vitro Diagnostics (IVD) in line with EU Regulations while ensuring that medical devices placed on the local market are safe and function as intended. The regulatory role of the Directorate is to manage the operations as the Maltese National Competent Authority for Medical Devices and In-Vitro Diagnostics through the overseeing of procedures relating to registration of economic operators, notification of Medical Devices/In-Vitro Diagnostics, vigilance and market surveillance. The Directorate is responsible to designate and continuously monitor the performance of Notified Bodies (NBs) registered in Malta and to establish, manage and oversee procedures related to clinical investigations and affairs. Through its pharmaceutical and scientific collaborative arm, the Directorate seeks to instil the concept of networking and establishing bridges between educational, pharmaceutical and scientific entities that can contribute to the functions of the Malta Medicines Authority in supporting clinical investigations and regulatory science operations in relation to quality, safety and efficacy.
For the Medical Device and Pharmaceutical Collaboration landing page click here.
Operation and Pharmacy Practice Unit
The Operations and Pharmacy Practice Unit within the Regulatory Operations, Medicines Intelligence and Access Directorate is responsible to develop, coordinate and monitor best practices to continuously improve patient-centred regulatory operations and pharmacy practice in line with the strategy of the Malta Medicines Authority. The Unit continuously monitors and optimises performance by periodically evaluating Key Performance Indicators (KPIs) in line with the vision, mission, values and strategic goals of the Authority, compiles and analyses regulatory data, performs community pharmacy inspections, coordinates EU and international regulatory affairs, public relations, oversees communication initiatives and compliance to data protection and freedom of information obligations.
Medicines Intelligence and Access Unit
The Medicines Intelligence and Access Unit (MIAU) within the Regulatory Operations, Medicines Intelligence and Access Directorate is responsible to manage a proactive and targeted patient-centred approach to compile medicines intelligence and enhance access to medicines. The Unit monitors the availability of medicines, assists the Licensing Authority in assessing exemption requests in accordance with Article 20 of the Medicines Act (Chapter 458 of the Laws of Malta), liaises with pharmaceutical stakeholders to ensure the continuous provision of medicines and supports the pharmaceutical industry to increase access to medicines for the benefit of consumers.
Information and Communication Technology Unit
The Information and Communications Technology (ICT) Unit deploys and maintains a robust and secure ICT infrastructure and application functionality to support the operations of the National Competent Authority (NCA) and legislation regulating the pharmaceutical sector.
Finance and Corporate Services Unit
The Finance and Corporate Services Unit (FCS) is responsible for the financial planning, accounting and control of the Malta Medicines Authority. It supports the information and decision making needs of Top Management. The Unit is also responsible for payroll, leave management system, time and attendance, all MMA procurement, travel and other administrative requirements of the Authority. Furthermore, it supports contractual and other obligations as is required from time to time.
Quality, Continuous Improvement and Internal Audit Unit
The Quality, Continuous Improvement and Internal Audit Unit is responsible for ensuring that processes needed for the quality management system are established, implemented and maintained. The Unit reports to Top Management on the performance of the quality management system and needs for improvement, and ensures the promotion of awareness of customer requirements throughout the organisation.
Legal Unit
The Legal Unit proactively analyses legal risks; oversees legal activities, which include services and resources that occur within the Authority; supports and advises Management on legal issues as required. The Unit offers timely legal advice and ensures compliance with all relevant legal, regulatory, and ethical standards through the protection of the property and reputation of the Authority in any contractual plans, litigation and otherwise. The Unit provides legal counsel by drafting, preparing, reviewing and updating bills, legal notices, submissions to court and other legal documents, while providing advice on necessary changes to legislative acts and pharmaceutical activities.
Educational Planning and Academic Development Unit
The Educational Planning and Academic Development Unit (EPAD) falls under the Advanced Scientific Initiatives Directorate. It merges training and education into the regulatory environment, strengthening the commitment of the MMA towards sustainable development through the accredited Academy for Patient-Centred Excellence and Innovation in Regulatory Sciences. The Academy serves as a key platform within the portfolio of the Authority, through which educational planning and academic development unfold. Primary initiatives include the organisation of interactive advanced courses on varied aspects of regulatory sciences that meet the needs of stakeholders by offering the opportunity to exchange views, enhance competence and overcome challenges. Through wide-ranging collaborations, the Academy provides a forum for national and international participants who share a vision for excellence in patient-centred endeavours.
Notified Bodies, Surveillance and Clinical Relations Unit
The Notified Bodies, Surveillance and Clinical Relations Unit within the Medical Devices and Pharmaceutical Collaboration Directorate is responsible to manage procedures related to clinical investigations and performance studies, Notified Bodies, vigilance and market surveillance of MDs and IVD. The Unit assesses and monitors the operations of conformity assessment bodies to designate Notified Bodies for Medical Devices; evaluates the operations of Notified Bodies; co-ordinates vigilance and surveillance of medical devices through the evaluation of reported incidents and complaints; liaises with stakeholders to address clinical medical device relations in order to safeguard the safety, efficacy and quality of medical devices on the market.
Cannabis for Medicinal and Research Purposes Unit
The Cannabis for Medicinal and Research Purposes Unit (CMRU) provides guidance and consultation on scientific matters to support research and development of, as well as accessibility to, quality medicinal cannabis. The Unit reviews submissions and issues recommendations for activities relating to cannabis for medicinal and research purposes which go through the approval processes in line with the relevant legislation, including the Drug Dependence (Treatment not Imprisonment) Act (DDA), Cap. 537 of the Laws of Malta, and the Production of Cannabis for Medicinal and Research Purposes Act, Cap. 578 of the Laws of Malta. Activities related to production operations are regulated through comprehensive evaluation of scientific and technical documentation, security considerations and good practices. Data on product reconciliation is compiled for the purposes of security and traceability of the cannabis supply chain, as well as for submissions as required through international reporting obligations.
Click here for further information on cannabis for medicinal and research purposes.
Pharmaceutical Products Entrepreneurship Unit
The Pharmaceutical Products Entrepreneurship Unit (PPE) is responsible to co-ordinate synergy in entrepreneurship processes within the MMA. The Unit spearheads projects of relevance to the Authority, especially in the area of pharmaceutical entrepreneurship. It enhances and collaborates with stakeholders on key players projects which require entrepreneurship skills, relating them to regulatory sciences whilst keeping patients interests and good governance at the centre of all its activities, with attention to possible conflict of interest.
People Management Unit
The People Management Unit within the Regulatory Operations, Medicines Intelligence and Access Directorate ensures a positive organisational culture which promotes development, innovation, integrity, equal opportunities and optimised capacity to support the overall strategic objectives of the Authority. The Unit is responsible to oversee recruitment and workforce planning, training and development, shaping and defining the culture of the Authority, resolving interpersonal conflicts, motivating the workforce, employee health, safety and wellbeing. The People Management team actively listens to requests made by employees, fellows and students, offers support and works alongside Management to provide positive feedback and effective guidance.
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