BEMA (Benchmarking of European Medicines Agencies) is a peer-review benchmarking exercise aimed at enhancing the reliability and consistent performance of national competent authorities regulating medicines across the EU network.
The agency received the highest scores and recognition for best practices in the following areas: strategic planning, staff involvement in achieving objectives, resource allocation across tasks, leadership, communication, transparency, internal audits, risk management, crisis management, IT systems, information security, clinical trials, and pharmacovigilance.
“The thorough three-day audit concluded with an excellent result, and I’m truly delighted,” said Katrin Kiisk, Director General of the State Agency of Medicines. “We’ve made a great leap forward. Our activities are well thought out—we are inclusive and engaged, contributing to healthcare in both Estonia and the EU. We’re focused on development and consistent in our decision-making. A successful audit is proof that we have a strong quality system, which forms the basis of trust—but it’s our people who bring it to life. I sincerely thank my dedicated colleagues for their hard work and commitment.” Kiisk added.
The assessment identifies each agency’s strengths and areas for improvement, and best practices are shared across the network. The BEMA framework includes 40 different criteria, covering both management systems and specific functional areas, such as clinical trials, marketing authorization applications, scientific advice, pharmacovigilance, and inspections.
Detailed areas of assessment include:
- Strategy and planning: How objectives and targets are set, what factors are considered, and how they are measured.
- Management decision processes: Decision-making, stakeholder involvement, metrics, procurement, conflict of interest handling, and prioritization under limited resources.
- Cascading to operational units and staff: How strategic and operational goals are communicated to individual employees.
- Resource allocation: Distribution of resources among various tasks.
- Performance monitoring and management actions: Consistency of operations, systems, financial and service monitoring.
- Communication of results: What is communicated, to whom and when, channels used, feedback collection and analysis, and how decisions are based on that.
- Leadership: Support, empowerment, opportunities for project leadership, decision-making authority, and how managers gather feedback.
- Values and ethics management: Conflict of interest declarations, organizational values, and ensuring ethical conduct.
- Stakeholders: Identification, regular and systematic feedback collection, and involvement.
- Transparency: Data protection and various forms of public information dissemination.
- Contribution to the EU network: Scientific assessments, supervision, and other involvement.
- Contribution to national health systems: Description and measurement of activities.
- Education and promotion of safety, quality, and efficacy reporting: Reporting of side effects, medication errors, and related communication, collection, and analysis.
- Quality management: Description of the quality system.
- Continuous improvement: Actions taken and factors considered.
- Internal audits
- Risk management: Risk registers, service coverage, and mitigation strategies.
- Conflict of interest procedures
- Crisis management and Business Continuity Planning (BCP): Covering agency infrastructure, staff, public, and animal health risks.
- Human resources management and recruitment
- Learning and development: Staff development plans and ensuring required competencies.
- Operations and capacity management
- System monitoring linked to objectives and targets
- Risk-based regulation: Targeting efforts with limited resources.
- Timeline compliance: Meeting regulatory deadlines.
- Information management and IT infrastructure
- Information resources: Access and use of scientific literature, standards, etc.
- Data transfer with EU databases: Quality control of data.
- Information protection
- Interdisciplinary collaboration: Cooperation between quality assessors, GMP/GDP inspectors, OMCLs.
- Scientific decision-making: Consistency and quality of assessments and inspections.
- Opinion- and decision-making processes
- Regulatory impact/effectiveness evaluation
- Clinical trials
- Scientific and regulatory advice
- Medicine availability
- Pharmacovigilance and safety-related decisions
- Inspections
