OBJECTIVES Ethical, economic and regulatory reasons of the importance of controlling metal impurities in ensuring the safety and efficacy of drugs will be explained. The research will present the current state of legislation (Ph.Eur., USP, ICH) and the announced changes in the requirements for the control of metal impurities in pharmaceuticals and explain the similarities and differences in the requirements/guidelines in this area. A literature study on the application of ICP-MS methods in the analysis of metal impurities in pharmaceuticals will be carried out, general characteristics of the technique will be discussed and a comparison with currently used methods based on a sulfide precipitation of the metals will be made. Critical assessment of the importance of compliance with these regulatory changes for the pharmaceutical industry will be made. MATERIAL AND METHODS For the purpose of this research the regulatory requirements related to changes in metal impurities analysis in pharmaceuticals were analyzed and compared: chapters of the European Pharmacopoeia (EP) and the US Pharmacopoeia (USP) and amendments, European Medicines Agency Guideline (EMA) and documents related to the international harmonization of guidelines for elemental impurities (ICH Q3D). Data available on the websites of EMA, ICH, USP, International Pharmaceutical Excipient Council (IPEC) and other were used. Scientific and technical papers which deal with testing of metal impurities in pharmaceuticals using the ICP-MS technique were found by searching available databases and electronic sources such as MEDLINE/PubMed, ScienceDirect, Elsevier and other. RESULTS Impurities in drugs may be organic or inorganic and originate from different sources. They have the potential to affect safety and efficacy of drugs. The existing internationally harmonized guidelines (ICH) concerning impurities in drugs and active pharmaceutical substances (Q3A, Q3B and Q3C) address the requirements for organic impurities and residual solvents. Current control of inorganic impurities is primarily based on pharmacopoeial requirements for heavy metals with questionable capabilities of detecting some toxicologically significant metals. With a focus on patient safety, the process of international harmonization of guidelines (ICH Q3D) has been initiated and the revision of relevant chapters in the USP and EP. Besides defining the metals to be monitored and stringent limits, the use of instrumental techniques in routine analysis is being proposed. This work gives a detailed overview of the proposed changes and shortcomings of traditional approaches, the benefits of the use of ICP-MS in complying with the more stringent requirements and the critical assessment of the risk-based approach in establishing an effective control system for metal impurities in pharmaceuticals. CONCLUSION Many shortages of currently valid pharmacopoeial methods for detection of limit concentrations of heavy metals have been proven and the most worrying is questionable capability of detecting some toxicologically significant metals. Development of modern analytical techniques made it possible to obtain quantitative and specific information regarding the content of metals in drugs and raw materials, while initiation of international harmonization of guidelines (ICH) and review of the relevant chapters in the USP and Ph.Eur. announced the period of use of instrumental techniques, particularly ICP-MS, for routine analysis. It is clear that the traditional limit test is no longer adequate to meet the needs of either the industry or patients. In addition to determining the metals to be monitored and defining the acceptable limits, selection of appropriate analytical method will be an important step in establishing an effective control system for metal impurities in pharmaceuticals.