European Directorate for the Quality of Medicines (EDQM)

The Istituto Superiore di Sanità (ISS, the National Institute of Health in Italy) is the Official Medicines Control Laboratory (OMCL) for Italy. Its functions are almost entirely carried out within the ISS National Centre for the Control and Evaluation of Medicine and the Biological Service. The ISS does not operate in an isolated manner but within a European context, where a network of official laboratories for the control of medicines has been established and made operational for the last twenty years, managed by the European Directorate for the Quality of Medicines (EDQM) based in Strasbourg, and operating within the Council of Europe area. The main task of OMCL network is the analytical control of drugs for human and/or veterinary use, carried out in various capacities and at various stages of the process of production, distribution and use of the drug by the citizen, with the aim of increasing the safety margins of the drug itself by checking its quality repeatedly at various levels, including when the drug is already on the market (AIFA annual control program).

The ISS through National Centre for the Control and Evaluation of Medicines fully participates in all European initiatives in the field of laboratory analysis of chemical and biological drugs, with particular emphasis on especially important matters, such as the fight against falsification, the batch-to-batch examination of vaccine or blood products to be placed on the Italian market not previously controlled by another European OMCL, and the analysis of medicines potentially containing defects or which have given rise to suspected adverse events reported by the pharmacovigilance system. This activity is managed in the European context in compliance with precise standards (ISO 17025) to guarantee a homogeneous behavior and result regardless of which OMCL performs the tests, in order to guarantee the mutual recognition of the results generated by an OMCL from another country.

This mutual recognition is supported by the fact that work corresponding to the ISO standards (International Organization for Standardization) is also assessed in the course of third-party audits conducted by teams managed by the EDQM and made up of experts from other European OMCLs . Therefore, during these audits, the OMCL network confirms a mutual trust in the results and conclusions both in relation to the pre-release tests on the market (batch release of vaccines and blood products) and other investigations on products, including those of Community interest. The harmonization of behavior between the various OMCLs is managed both at a cultural and technical level, through the use of shared documents, which cover activities related to both human and veterinary, chemical and biological drugs and through meetings held at various levels and with different frequency.

The ISS performs its function of OMCL both independently and upon request of the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) or other authorities, in relation to the various types of problems to be addressed.