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 criteriathe regulatory authority's category and size. The value of the paper is twofold. First, the new generi...c 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. Copyright
Source:
International Journal of Health Planning and Management, 2016, 31, 1Publisher:
- Wiley-Blackwell, Hoboken
DOI: 10.1002/hpm.2265
ISSN: 0749-6753
PubMed: 24986713
WoS: 000373068500002
Scopus: 2-s2.0-84961216111
Collections
Institution/Community
PharmacyTY - JOUR AU - Pejović, Gordana AU - Filipović, Jovan AU - Tasić, Ljiljana AU - Marinković, Valentina PY - 2016 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2601 AB - 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 criteriathe 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. Copyright PB - Wiley-Blackwell, Hoboken T2 - International Journal of Health Planning and Management T1 - Towards medicines regulatory authorities' quality performance improvement: value for public health VL - 31 IS - 1 DO - 10.1002/hpm.2265 ER -
@article{ author = "Pejović, Gordana and Filipović, Jovan and Tasić, Ljiljana and Marinković, Valentina", year = "2016", 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 criteriathe 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. Copyright", publisher = "Wiley-Blackwell, Hoboken", journal = "International Journal of Health Planning and Management", title = "Towards medicines regulatory authorities' quality performance improvement: value for public health", volume = "31", number = "1", doi = "10.1002/hpm.2265" }
Pejović, G., Filipović, J., Tasić, L.,& Marinković, V.. (2016). Towards medicines regulatory authorities' quality performance improvement: value for public health. in International Journal of Health Planning and Management Wiley-Blackwell, Hoboken., 31(1). https://doi.org/10.1002/hpm.2265
Pejović G, Filipović J, Tasić L, Marinković V. Towards medicines regulatory authorities' quality performance improvement: value for public health. in International Journal of Health Planning and Management. 2016;31(1). doi:10.1002/hpm.2265 .
Pejović, Gordana, Filipović, Jovan, Tasić, Ljiljana, Marinković, Valentina, "Towards medicines regulatory authorities' quality performance improvement: value for public health" in International Journal of Health Planning and Management, 31, no. 1 (2016), https://doi.org/10.1002/hpm.2265 . .