PRESS RELEASE BY THE MINISTRY FOR SOCIAL DIALOGUE, CONSUMER AFFAIRS ANAD CIVIL LIBERTIES: Malta hosting two scientific committees of the European Medicines Agency on medicines for children and safety of medicines

Malta is currently hosting a joint meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) and the Paediatric Committee related to the Malta Medicines Authority activities as part of the Maltese Presidency.

In her opening address, Minister for Social Dialogue, Consumer Affairs and Civil Liberties Helena Dalli spoke about the important role of the PRAC in implementing proactive safety monitoring and prompt benefit risk action in the use of medicinal products.

Minister Dalli remarked how risk in pharmacovigilance is of special relevance to certain population groups, especially children, where specific considerations are required.

Referring to the Paediatric Committee, Dr Dalli said that this committee has been instrumental in facilitating the development of medicines for children. The Minister said that the regulatory framework and strengthened dialogue with stakeholders are helping to improve access to authorised medicinal products for children.

Minister Dalli explained how intense effort is also being dedicated to streamlining the work of the regulators, to support development and accessibility of medicines for children with rare diseases.

Touching upon the role of the Malta Medicines Authority, Dr Dalli said that the Authority has a proactive approach in both pharmacovigilance and paediatrics. The Minister mentioned how in the last few years, the competent national Authority has extended its capacity by setting up two new units, the Medicines Intelligence and Access Unit and the Research, Scientific Affairs and Innovation Unit which has been set up in the past weeks.

Minister Dalli also noted the engagement registered on the Authority’s social media – a record of 138% increase in the number of adverse drug reaction (ADR) reports together with positive feedback from stakeholders.

“This successful activity portrays a proactive approach to safety communication,” concluded Dr Dalli.

Source: Government of Malta