Mission and Objectives


Our vision is to be a centre of excellence in advancing effective and innovative regulation and promoting quality and scientific rigour in the work we do. We strive to be a best in class regulator for the benefit of patients and stakeholders. We endeavour to be an internationally recognised, efficient entity and promoter of people development and sustainable growth.



The Mission of the Malta Medicines Authority is to safeguard public health through the regulation of medical products and pharmaceutical activities for human use.



The Objectives of the Medicines Authority are:

  1. To perform duties delegated to the Medicines Authority by the Licensing Authority through the Medicines Act.

  2. To assist and advise the Licensing Authority on any matter relating to the regulation of medical products and related activities.

  3. To ensure in so far as possible and consistent with current medical and scientific knowledge, that medical products marketed in Malta and the European Union are of good quality and have a favourable risk to benefit profile through independent, science-based assessment, post-authorisation activities and participation in decision-making at European level.

  4. To scientifically evaluate requests and monitor clinical trials carried out in Malta.

  5. To ensure, that medical products supplied on the local market through the regulated supply chain are of good quality, safe for the public and as per the intended use.

  6. To provide high quality monitoring and inspection services for pharmaceutical activities, local medical device economic operators and the performance of Notified Bodies registered in Malta.

  7. To monitor the safety of medical products.

  8. To monitor and enforce the relevant legislation through investigation of potential breaches of regulations and a range of measures.

  9. To enhance the effective, safe and rational use of medical products through the provision of objective and unbiased information which helps prescribers, healthcare professionals and patients make informed decisions on the choice and use of medicines.
  10. To support the availability of medical products on the local market.

  11. To support competitiveness of the local market through scientific and regulatory advice and the implementation of principles of SMART Regulation.

  12. To utilise and develop tools, standards, and approaches to assess and ensure the safety, quality and effectiveness of medical products, and pharmaceutical activities.

  13. To enhance the standard of medicinal products and pharmaceutical activities for medicines for human use in Malta.

  14. To manage developments related to scientific research, innovation, and academic initiatives, in line with the strategy of the Medicines Authority.

  15. To support the regulation of cannabis for medicinal and research purposes through guidance, technical review, and stakeholder engagement among other areas.

  16. Process and investigate complaints received regarding advertised medicinal products and provide guidance as laid down in the advertising regulations.

  17. To participate on European fora of the European Medicines Agency, Council, working groups, and the Commission and perform assessment and give scientific and regulatory positions in various areas.



For the strategy of the Medicines Authority please click here