Anthia Zammit
AnthiaZammit Legal, Malta.
Title: Global Market Expansion: Life Science and Pharmaceutical developments in Malta, the Mediterranean, and beyond
Biography
Biography: Anthia Zammit
Abstract
Malta’s annual pharmaceutical export turnover exceeded €208 million in 2010, reached €256 million by 2012 (EFPIA), and was estimated at over €295 million in 2014 (Times of Malta). Active stakeholders in Malta include licensed wholesale distributors, importers, re-packagers, and manufacturers of finished dosage forms, active pharmaceutical ingredients (APIs), medical gases, and devices. The successful outcomes and expansion of multinational companies are testament to Malta’s role as a global business and distribution hub of pharmaceuticals and medical devices to the European, U.S., North African, and Middle Eastern markets. The cost of researching and developing a new chemical/biological entity was estimated at €1,172 billion in 2012 (EFPIA). The critical need for innovation and R&D of safe, high quality, efficacious medicinal products requires cross-disciplinary international collaboration. Malta, the smallest island-member state of the EU with strategic geographic location and unique history, is gaining momentum and reputation in pharmaceutical, life science, and biotechnology development in the Mediterranean. In November 2014, representatives of the US FDA met with those of the European Medicines Agency (EMA), the European Commission, and Good Manufacturing Practice (GMP) experts from EU member states to make progress on mutual reliance between the FDA and EU on GMP inspections, demonstrating strengthened momentum on this issue. As a EU member state, Malta is a party to Mutual Recognition Agreements (MRAs) for Good Manufacturing Practice (GMP) with Switzerland, Australia, New Zealand, Canada and Japan. The body of EU legislation regulating medicinal products for human use is transposed into Maltese legislation. The Malta Medicines Authority grants EU GMP and EU GDP certification to compliant companies. Manufacturing plants and facilities in Malta successfully pass U.S. Food and Drug Administration (FDA) inspections. Malta’s national competent authority furthermore engages in discussions on the harmonisation of medicines regulation via the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and as a member of the Pharmaceutical Inspection Cooperation/Scheme (PIC/S).