title: A review of the National pharmacovigilance system in Malta - implementing and operating a pharmacovigilance management system.
abstract: Regulatory authorities have a legal mandate to implement and maintain a Pharmacovigilance System designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance. Areas covered: This review maps the implementation of pharmacovigilance activities in Malta since accession in the EU in mid 2004 and discusses the challenges the Maltese Regulator encountered while setting up adequate and effective systems to fulfil its legal mandate. Areas reviewed are those around ADR reporting, promotion and safety communications including rapid alerts and recalls, direct healthcare professional communications, risk minimisation measures and safety circulars and quality systems. Expert opinion: Within a ten year period, 3 EU directives on pharmacovigilance were implemented by our agency. Despite limitations to resources, based on a prioritised implementation, the legislation provisions are now fully operational with a good level of sustainability. Lessons learnt from this process are discussed in this review. The coming years will involve strengthening and consolidation of existing processes.
authors.affiliation: a Post-Licensing Directorate Medicines Authority , Gzira , Malta.
authors.forename: Amy
authors.initials: A
authors.lastname: Tanti
authors.affiliation: a Post-Licensing Directorate Medicines Authority , Gzira , Malta.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Micallef
authors.affiliation: a Post-Licensing Directorate Medicines Authority , Gzira , Malta.|b Department of Pharmacy , University of Malta , Msida , Malta.
authors.forename: Anthony
authors.initials: A
authors.lastname: Serracino-Inglott
authors.affiliation: a Post-Licensing Directorate Medicines Authority , Gzira , Malta.|c Course in Pharmacy, Department of Biology , University of Tor Vergata , Rome , Italy.
authors.forename: John-Joseph
authors.initials: JJ
authors.lastname: Borg
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence* / Q000458:organization & administration; D003142:Communication; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005062:European Union; D006801:Humans; D007880:Legislation, Drug; D008319:Malta; D060735:Pharmacovigilance; D012308:Risk Management / Q000379:methods
keywords: Adverse drug reactions; pharmacovigilance; regulation; safety communications