Pharmaceutical Innovation and Production: Global Trends and Legal Challenges. New tariffs imposed by the United States starting October 1 2025… read more →
The EU pharmaceutical package aims to accelerate life sciences industries growth and promote sustainable healthcare systems for European patients. Patient access, market access, availability disparities, supply shortages, and supply chain and innovation challenges drive review and reform of the EU pharmaceutical legislation—the foundation of pharmaceutical industry manufacturing of safe, effective, high quality medicinal products in Malta and European countries.
Medicinal products in Malta are regulated by the Licensing Authority (the Superintendent of Public Health) and the Medicines Authority. The regulatory supervision covers all procedures and operations in manufacturing, wholesale dealing, pharmacies, selling, and dispensing medicinal products. The layered regulatory system, consists of laws, primarily the Public Health Act, and the Medicines Act and subsidiary legislation. The legislation implements European Directive 2001/83 with underlying regulations, licensing conditions, and guidance documents published by the Medicines Authority which interpret standards included in statutory provisions.
Despite Malta’s efforts to implement EU legislation and provide universal healthcare coverage, disparities in access to medicines persist within the European Union. The country’s small population size, coupled with high levels of out-of-pocket spending on healthcare, poses challenges to ensuring equitable access to medications for all residents. Additionally, the existence of a two-tier healthcare system, comprising both public and private sectors, further complicates the landscape of healthcare delivery and access to pharmaceuticals. While initiatives such as the implementation of electronic medical records aim to enhance healthcare services, ongoing efforts are needed to address the underlying factors contributing to unequal access to medicines in Malta and across the EU.
In Malta’s healthcare sector, the pricing and reimbursement strategies for medicinal products and medical devices reflect a distinct dual-market system. The public sector, driven by principles of social solidarity, offers patients access to essential medications free of charge, selected from a government-regulated formulary.
i Classification The Medicines Authority’s Borderline Classification Committee distinguishes between medicinal and non-medicinal products. Assessments are made on a case-by-case… read more →
The latest developments in Article 126a Authorisations in Malta. Article 126a is now considered as the last resort option, if no other type of authorisation procedure is available EIPG
On 21 October 2020, Dr Anthia A Zammit presented the eighth edition of the The Life Sciences Law Review to the President… read more →
For the first time, Malta is featured in The Life Sciences Law Review (8th edition) published by Law Business Research… read more →
Sunday Times of Malta, 4 February 2018 At the end of last year, the European Commission launched its consultation to… read more →