National center for drug research and evaluation

Responsible: Dr. Patrizia Popoli
phone: (+39) 06 4990 2482-2737


Center activities

Our mission is to promote the discovery, development and testing of drugs in order to protect and improve public health. These objectives are pursued through preclinical and clinical research, technical-scientific and regulatory evaluation of the preclinical and clinical studies on new drugs, research and evaluation on the benefit-risk profile and on the place in therapy of drugs in the post- authorization phase. The Center is involved in many institutional tasks (participation in national and international committees, technical tables and working groups) and in different training, information and communication activities (teaching in University and Master courses, annual organization of conferences and workshops on the themes of drug evaluation and research, dissemination of data and information on web pages).


Organization of the center

The structure is organized into 3 operating units:

Unit Pharmacological research and experimental therapy 

This unit makes use of the contribution of research groups sharing the objective of identifying and validating new therapeutic approaches for diseases. This objective is pursued through the generation of new knowledge thanks to research in experimental pharmacology, the study of the pathogenetic mechanisms responsible for diseases, the development and / or refinement of experimental models, the evaluation of the efficacy and safety of new drugs (or repositioned drugs) in appropriate cell and animal models of pathology. The development and biological evaluation of nanotechnology platforms for the delivery of therapeutic agents (including substances of natural origin) represent a further approach to the development of effective and safe drugs. The unit is organized into 6 thematic areas: Central nervous system, Chronic inflammatory diseases, Onco-hematology, Pain therapy, Molecular pharmacology, and Nanomedicine for integrated therapies.

Unit Preclinical and clinical evaluation of drugs 

The unit is dedicated to the evaluation of the non-clinical and clinical effects of drugs in order to establish their inclusion in clinical trials (from Phase I -managed according to Ministerial Decree of 27.04.2015-  to Phases II and III, on specific request of the Italian Medicines Agency, AIFA), and their subsequent registration by national or international procedures. Other activities include the release of technical advice (e.g. scientific advice, procedures for inclusion in the lists 648/96) or evaluation in the Voluntary Harmonization Procedure (VHP). The unit also assesses the eligibility of animal testing in the pharmacological field and participates in inspections related to Good laboratory practice (GLP).

Phase I clinical trials

Unit Pharmacoepidemiology and pharmacosurveillance

The research activities of the unit focus on the following areas: post-marketing epidemiological studies to produce new knowledge on the benefit-risk profile of drugs; national and regional drugs-utilization studies; surveillance on potential adverse reactions to drugs, vaccines and products of natural origin, and support for national and regional pharmacovigilance activities; innovative models for improving the quality of care for people with chronic diseases.