ACTIVITY ON THE DEVELOPMENT OF GOOD GOVERNANCE PRACTICE HAS BEEN FINALISED
In the course of 1 -5 October 2018 the last mission on the Development of Good Governance Practice within the Activity 5.2 of the EU funded Twinning project “Strengthening of the Medicines and Medical Devices Agency of the Republic of Moldova (MMDA) as regulatory agency in the field of medicines, medical devices and pharmaceutical activity” has been organized.
The Short Term Experts from the Office for Registration of Medicinal Products Medical Devices and Biocidal Products of the Republic of Poland and from the States Medicines Control Agency under the Ministry of Health of the Republic of Lithuania carried out the Benchamarking of European Medicines Agencies (BEMA) self-assessment.
As a result, the BEMA auditors concluded that the MMDA is well governed and appropriately prepared in terms of scientific and regulatory knowledge to carry out activities as National Competent Authority for medicinal products.
The assessors commented that the quality management system is well developed and continuously monitored, all activities are covered by internal audits and relevant ISO standards are adhered to. Additional, well established procedures are followed across the MMDA, and the recent changes of competence and structure of the MMDA show sufficient flexibility and efficacy of managerial processes in the agency. Also, GxP inspection system was mentioned as a strong element of organization. Development and implementation of electronic tracking system in the area of authorization of medicinal products was also stressed as a strong point of the MMDA.
Even though, the BEMA auditors defined some areas that need further improvements, e.g. crisis management or general timelines compliance monitoring.
BEMA is a tool for the improvement of regulatory quality management system and consistency of best practices across the EU network of medicines agencies. The BEMA methodology includes both self-assessment and peer review assessment, and is broadly based on ISO 9004 guidelines. The main aim of the BEMA is to contribute to the development of a world-class medicines regulatory system based on a network of agencies operating to best practice standards.
As the result of the Activity, a full package of recommendations will be provided in the final analytical report on Good Governance including the evaluation of the current system.