title: Towards medicines regulatory authorities' quality performance improvement: value for public health.
abstract: The purpose of this article is to explore the possibility of implementing total quality management (TQM) principles in national medicines regulatory authorities in Europe to achieve all public health objectives. Bearing in mind that medicines regulation is a governmental function that serves societal objectives to protect and promote public health, measuring the effective achievement of quality objectives related to public health is of utmost importance. A generic TQM model for meeting public health objectives was developed and was tested on 10 European national medicines regulatory authorities with different regulatory performances. Participating national medicines regulatory authorities recognised all TQM factors of the proposed model in implemented systems with different degrees of understanding. An analysis of responses was performed within the framework of two established criteria-the regulatory authority's category and size. The value of the paper is twofold. First, the new generic TQM model proposes to integrate four public health objectives with six TQM factors. Second, national medicines regulatory authorities were analysed as public organisations and health authorities to develop a proper tool for assessing their regulatory performance. The paper emphasises the importance of designing an adequate approach to performance measurement of quality management systems in medicines regulatory authorities that will support their public service missions.
authors.affiliation: Medicines and Medical Devices Agency of Serbia, Belgrade, Serbia.|Department for Quality Management, Faculty of Organizational Science, University of Belgrade, Belgrade, Serbia.
authors.forename: Gordana
authors.initials: G
authors.lastname: Pejović
authors.affiliation: Department for Quality Management, Faculty of Organizational Science, University of Belgrade, Belgrade, Serbia.
authors.forename: Jovan
authors.initials: J
authors.lastname: Filipović
authors.affiliation: Department for Social Pharmacy and Pharmaceutical Legislation, Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia.
authors.forename: Ljiljana
authors.initials: L
authors.lastname: Tasić
authors.affiliation: Department for Social Pharmacy and Pharmaceutical Legislation, Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia.
authors.forename: Valentina
authors.initials: V
authors.lastname: Marinković
mesh_terms: D004335:Drug and Narcotic Control / Q000458:organization & administration*; D006077:Government Agencies / Q000458:organization & administration / Q000592:standards; D006801:Humans; D011634:Public Health / Q000379:methods; D011635:Public Health Administration; D058996:Quality Improvement; D017749:Total Quality Management / Q000458:organization & administration
keywords: generic TQM model; medicines regulatory authority; performance; public health; public organisations