Monday 21 April 2025

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Batch Release and Testing

As the national regulator, the Malta Medicines Authority is highly respected within the EU and beyond. Medicines registered with the Authority enjoy mutual recognition by the United States’ Food and Drug Administration, making accreditation in Malta especially beneficial.

The Medicines Authority oversees operators’ compliance with Good Manufacturing Practices (GMP) and processes licences and authorisations for all medicinal products. In this role, it also competes globally, attracting pharmaceutical companies to register their products in Malta for batch release, testing and validation.

As a European reference state, Maltese registration allows producers to market their products across the EU with a trusted seal of approval. While some countries offer cheaper registration, they often charge an export tax on each unit exported, whereas Malta does not, making it the preferred choice for large exporters.

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