Narodowy Instytut Leków (National Medicines Institute) (NIL) was established as a result of a merger of the Instytut Leków (Institute of Medicine) with its seat in Warsaw and Centralne Laboratorium Surowic I Szczepionek (Central Laboratory of Serum and Vaccines) with its seat in Warsaw, receiving the name of Narodowy Instytut Zdrowia Publicznego (National Institute of Public Health). On 8 December 2006. The Institute was renamed Narodowy Instytut Leków (pursuant to the Regulation of the Minister of Health of 3 November 2006, Dz. No 210 item 1554).
Narodowy Instytut Leków is a research institute acting for the benefit of public health protection. Among the most important tasks assigned by the Minister of Health is quality control of medicinal products and medical devices. The NIL, together with other national control laboratories in the EU, forms a network of laboratories which, in cooperation with the European Directorate for the Quality of Medicines and Health Care (EDQM), supervise the safety and quality of medicines throughout the EU. NIL acts in the interest and for the benefit of every patient, upholding safe, therapeutically effective and high quality medicines.
As part of its socially important tasks, the Institute actively participates in the fight against infections caused by dangerous microorganisms. The Institute has two national reference centers (KOROUN and KORLD) monitoring the spread of resistant strains of bacterial species, clinically and epidemiologically important in Poland, in both hospital and non-hospital environments. Through drug susceptibility testing, resistance mechanisms, serological tests, issuing recommendations and conducting training and information campaigns, NIL counteracts the serious threat of the emergence and spread of antibiotic resistance in microorganisms and provides data necessary to undertake appropriate immunoprophylaxis of selected invasive infections.
The Institute serves as an institutional expert witness in many cases involving the adulteration of drugs and dietary supplements. It also deals with detection of prohibited substances in sport and new psychoactive substances. Based on research results, NIL prepares expert opinions for law enforcement agencies and state institutions responsible for legal regulations in this field.
The Institute’s activity is interdisciplinary and covers such scientific fields as pharmacy, pharmacology, chemistry, biochemistry, biophysics, microbiology, molecular biology, epidemiology, serology, vaccinology, diagnostics. Many of the ongoing projects are innovative on a national and European scale, including research in cell biology, molecular microbiology, drug resistance of microorganisms, effectiveness of infection control programs, effectiveness of immunizations and antimicrobial drugs, as well as research on new synthetic drugs.
The Institute’s work consists of scientific research, state control activities, implementation programs, and reference, consulting, and educational activities for the staff of health care institutions, scientific institutes, and universities.
NIL also acts as a service laboratory for private entities. Through its special purpose vehicle InnoNIL, services are offered in such areas as: quality assessment of pharmaceutical raw materials and active substances, development of analytical methods, testing of biocompatibility and chemical safety of medical devices, quality testing of probiotics, as well as microbiological expertise and genetic analysis.
Narodowy Instytut Leków has implemented a quality management system compliant with PN-EN ISO/IEC 17025:2005 standard, which is confirmed by the Accreditation Certificate issued by the Polish Centre for Accreditation and attestation issued by the European Directorate of Quality of Medicines (EDQM) in Strasbourg.