International acknowledgments and accomplishments
Agency for Medicinal Products and Medical Devices of the Republic of Croatia (HALMED) has been continuously improving the quality system through the years, which has resulted in receiving a large number of various acknowledgments at the international level:
- WHO has approved designation of the European Medicines Regulatory Network (EMRN) as WHO Listed Authorities (WLAs) that can be relied on for fulfilling the highest level of regulatory standards and practices for quality, safety and efficacy of medicinal products and vaccines. The decision is based on the recommendation by the WHO technical advisory group on WHO Listed Authorities (TAG-WLA), following WHO performance evaluations confirming consistency of advanced performance by the EU/EEA. The EMRN was evaluated as a "single entity” during the WLA initiative.
- In the WLA initiative, which started in March 2022, HALMED participated as self-assessor by drafting answers to all the indicators listed in the questionnaire for the entire EMRN, while representatives of the EMA and BASG-AGES were responsible for reviewing the completeness of the data. Communication and coordination with other stakeholders within the EMRN and with the WHO was carried out by the co-chairs of the BEMA Steering Group and representatives of the BEMA Secretariat at HALMED.
- WLA is a regulatory authority or a regional regulatory system which has been evaluated to comply with all the indicators and requirements specified by WHO. The WLA initiative is being implemented by WHO to promote access to and supply of safe, effective, and high quality medicinal products. It ensures optimal use of limited global regulatory resources by regulatory authorities that lack the resources to perform all necessary regulatory functions, or which have not yet reached higher maturity levels for medical product oversight.
- HALMED’s OMCL received the first EDQM attestation in July 2013, upon the Republic of Croatia’s accession to the European Union. Moreover, the World Health Organisation (WHO) confirmed in 2015 that the procedure of prequalification of HALMED's OMCL for quality control of antimalarial, anti-tuberculosis and anti-HIV medicinal products had been successfully completed, confirming the quality of the OMCL’s work worldwide.
- The re-attestation enables HALMED’s OMCL to retain active participation in the mutual recognition and exchange of business and medicinal products testing results within the OMCL network as an equal partner to other laboratories within the OMCL network.
- The re-attestation also confirms that HALMED’s OMCL still meets all the requirements of the ISO EN 17025:2017 standard, acknowledging its competence, technical equipment, knowledge and quality once again.
In 2016 HALMED successfully joined the Joint Audit Program (JAP)
- This enabled HALMED to continue conducting supervision of Good Manufacturing Practice in Croatia, as well as in third countries, and to continue issuing certificates of Good Manufacturing Practice (GMP certificates) that are recognized outside Croatia.
- Many HALMED’s business indicators were assessed as the best practice at the EU level. With an exceptional result, HALMED has confirmed its place at the very top of the European medicines regulatory network. In comparison, the average score of all agencies in the previous BEMA cycle was 3,4. The highest rankings were achieved for the safety monitoring system of medicines, education and promotion of reporting on safety, quality and efficacy of medicinal products, setting strategic targets, goals and objectives, quality management system, information system, conducting inspections and contribution to the national health system.
- The Benchmarking of European Medicines Agencies (BEMA) is carried out by the Heads of Medicines Agencies (HMA). The aim of this programme is to assess the current Agency’s ranking, identify the best practices in certain European agencies and provide recommendations for further improvement of procedures.
- HALMED was ranked among the top agencies within the EU regulatory network initially in 2014, participating in the BEMA evaluation process for the first time, immediately after joining the European Union. Even then, HALMED received high overall rating of 4.1, as well as the highest number of excellent ratings (5) among all rated agencies. This rating has been confirmed by the latest success and has increased further, thanks to continuous improvements and enhancements in the work of HALMED.
- Based on the assessment conducted, the FDA concluded that the inspection system of HALMED fully complies with the requirements of the FDA. The FDA’s decision to acknowledge the said inspectorates included the national medicinal products regulatory bodies of Austria, France, Croatia, Italy, Malta, Spain, Sweden and United Kingdom. This also marked the first time that the FDA decided to acknowledge another country's inspectorate.
- The FDA’s decision indicates a new milestone towards cooperation between the European Union (EU) and the United States of America (USA) regarding mutual recognition of inspections of manufacturing sites for human medicines carried out in their respective territories. The European Commission (EC) confirmed the same year that inspections of good manufacturing practice carried out by the FDA were in line with the EU standards and could be recognised by other EU member states.
- The Republic of Croatia and HALMED are hereby added to the list of regulatory bodies encompassed by the Mutual Recognition Agreement between the European Commission and Canada.
- Based on the agreement between the European Commission and Canada, regulatory bodies encompassed by the agreement can exchange information on marketing authorisations and safety of medicinal products, accept manufacturing licences as well as accept and exchange good manufacturing practice certificates. According to the agreement, regulatory bodies also retain the right to conduct inspections on the territory of another party. In that respect, the Canadian regulatory body can conduct inspections in Croatia, whereas HALMED can conduct inspections in Canada.
- The decision to accept HALMED as the 48th member of PIC/S was based on the detailed assessment of HALMED's quality system, inspection practice as well as competence of its Official Medicines Control Laboratory (OMCL).
- PIC/S ensures an active co-operation in the field of good manufacturing practice, facilitates experience and information exchange, promotes improvement and harmonisation of standards and inspection procedures of pharmaceutical manufacturers and maintains mutual trust among competent authorities. The competent authority’s PIC/S membership is also beneficial to manufacturers as it reduces double inspections and enables additional access to international markets.
- The procedure of prequalification of HALMED's Official Medicines Control Laboratory Division (OMCL) for quality control of antimalarial, anti-tuberculosis and anti-HIV medicinal products was conducted in 2015. The WHO inspection team concluded that HALMED's laboratory operates in line with the WHO Good Practices for Pharmaceutical Quality Control Laboratories (GPPQCL). Thereby, HALMED's Official Medicines Control Laboratory Division received an acknowledgement of its competence, technical capacity, knowledge as well as quality of its work on a global scale.
