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Home / Organisation / About Us / Quality Management

Quality Management

Quality Management
A Quality Management System (QMS) was set up by the Malta Medicines Authority (MMA) in 2004 during the accession period as part of a project with another European National Competent Authority (NCA) to become in line with EU standards.

As an internationally certified institution according to the ISO 9001:2015, the MMA upholds the highest standards of governance and is fully committed towards improved quality management.

The QMS is constantly improving through internal audits, the Benchmarking of the European Medicines Agencies (BEMA) assessments, the Joint Audit Programme (JAP) audits, the National Audit Office (NAO) audits, the annual financial audits and regular compliance checks by the central Government.

ISO Certification
The QMS covers all activities (core and support) and is based on the ISO 9001:2015 principles. The QMS of the Malta Medicines Authority has been certified on the basis of the MSA EN ISO9001-2015 since 2013, and has been recertified every 3 years ever since, with the last recertification being in 2023.

Benchmarking of the European Medicines Agencies (BEMA)
The BEMA is an exercise within the EU medicines regulatory network established by the Heads of Medicines Agencies (HMA). It aims at combined efforts between agencies in sharing information to improve their systems and processes. The objective of the Benchmarking exercise is to contribute to the development of a world-class pharmaceutical regulatory system, based on a network of agencies, operating to best practice standards. The MMA has participated in the BEMA I, BEMA II, BEMA III, BEMA IV and BEMA V assessments, the latter carried out in March 2023.