Quality management

The HPRA has established a quality management system to meet its legislative and regulatory requirements, as well as the needs and expectations of all its stakeholders. The system is based on the approach and requirements of ISO 9001, and takes into account guidelines, standards and best practices from Irish and international organisations. It is implemented and operated by all HPRA staff, with a dedicated section in place to oversee and co-ordinate the work.

The quality system also focuses on continual improvement through measuring and monitoring performance, management reviews and identification of opportunities for improvement, operational excellence and lean management and benchmarking.

Internal audits are carried out to help provide assurance that the system is operating effectively and help to contribute to the improvement of systems and processes. A summary of the results of the HPRA's pharmacovigilance system internal audits is sent to the European Commission, as per Article 101(2) of Directive 2001/83/EU.

Benchmarking and external reviews

The benchmarking of European Medicines Agencies (BEMA) is based on a self-assessment by each EU medicines agency against a set of indicators covering management systems and technical work in the areas of assessment of marketing authorisation applications, pharmacovigilance (drug safety), and inspections. The exercise is not designed for direct comparison or ranking of agencies.

Following a self-assessment, assessors from other Member States conduct an independent assessment of the agency and compile a report with their findings, identified strengths/best practices of the agency and areas for further improvement. These external reviews provide an excellent opportunity to help improve our systems and processes.

The BEMA programme is entering its fifth cycle of visits which began in 2022 and will end in 2025.