The Mission of the Medicines Authority is to protect and enhance public health through the regulation of medicinal products and pharmaceutical activities.
The Objectives of the Medicines Authority are:
To perform duties delegated to the Medicines Authority by the Licensing Authority through the Medicines Act.
To assist and advise the Licensing Authority on any matter relating to the regulation of medicinal products and related activities
To ensure in so far as possible and consistent with current medical and scientific knowledge, that medicinal 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.
To scientifically evaluate requests and monitor clinical trials carried out in Malta.
To ensure, in so far as possible, that the medicines supplied on the local market through the regulated supply chain are of good quality.
To provide high quality monitoring and inspection services for pharmaceutical activities.
To monitor the safety of medicinal products.
To monitor and enforce the relevant legislation through investigation of potential breaches of regulations and a range of measures.
To enhance the effective, safe and rational use of medicinal 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.
To support the availability of medicinal products on the local market.
To support competitiveness of the local market through scientific and regulatory advice and the implementation of principles of SMART Regulation.
To utilise and develop tools, standards and approaches to assess and ensure the safety, quality and effectiveness of medicinal products and pharmaceutical activities.
To enhance the standard of medicinal products and pharmaceutical activities for medicines for human use in Malta.
To participate on European fora of the European Medicines Agency, Council and the Commission and perform assessment and give scientific and regulatory positions in various areas.
Sir Temi Żammit Buildings,
Malta Life Sciences Park,
San Ġwann SĠN 3000
Telephone: 356 2343 9000 (from 7:30 to 15:45)
Helpline: 356 2343 9111 (from 9:00 to 12:00)
Fax: 356 2343 9161