A total of 660 new medicines were approved in 2017, bringing the total available in Malta to 5,459.

There are a number of ways in which medicines gain approval, such as national and European procedures, and parallel import licences.

There were 26 overall number of authorisation procedures in 2017 with Malta in the lead role. In 2017, Malta ranked 11th out of the 28 member states, in the number of procedures finalised and started with the role of Reference Member State.

“With planned enhanced capacity and the focus on the competence of its staff, the authority is carrying out these procedures for a more diverse range of medicinal products,” the authority said in its annual report presented to parliament on Monday.

“New pharmacists and assessors have been recruited and external experts engaged to complement the existing experienced team for the technical coordination and assessment of dossiers for these procedures. This ensures adequate capacity to handle more procedures. Additional resources are planned for 2018 as the work in these activities increases.”

The report also revealed that there had been 185 reports detailing at least one adverse drug reaction to the medicinal product concerned, resulting in a cumulative total of 344. It also said that in three out every four cases the reaction was ‘serious’.

Each case report received at the Malta Medicines Authority was assessed and
reported electronically to the European Medicines Agency and the World Health Organisation as the central adverse drug reaction repositories.

Adverse drug reaction databases maintained at these organisations typically comprise essential medicinal product safety monitoring tools which allow for the identification of potential/novel safety signals associated with the use of specific drugs particularly when these are administered at certain doses and/or to distinct patient categories.