HRPRES2020: HALMED hosted meetings related to medicinal products and medical devices during the Croatian Presidency of the EU Council
Today marks the end of the six-month period of the Croatian Presidency of the Council of the European Union, during which Agency for Medicinal Products and Medical Devices of Croatia (HALMED) hosted a series of meetings of European scientific committees and working groups in the field of medicinal products and medical devices. By organising the meetings and participating in the work of committees and working groups during HRPRES2020, HALMED provided support to the continuity of the EU Regulatory Network, while through the role of host continuing to promote the positive international reputation of the Republic of Croatia.
During the Croatian Presidency, from 1 January to 30 June 2020, HALMED hosted seven meetings of committees and working groups in total. Due to the COVID-19 pandemic, five meetings were held virtually, one meeting was conducted as a written procedure and one meeting was held physically before the occurrence of circumstances related to COVID-19.
Moreover, additional meetings of committees and working groups from HALMED’s area of jurisdiction were held under the Croatian Presidency sponsorship, organized by regulatory authorities of other EU Member States and the European Medicines Agency (EMA).
Apart from the stated meetings, HALMED's representatives who are members of the expert team were involved in the activities of the Working Party on Pharmaceuticals and Medical Devices meetings in Brussels.
During the Croatian Presidency HALMED hosted the following meetings
- Committee for Orphan Medicinal Products (COMP), 12 - 14 February 2020, Zagreb
- The 99th Heads of Medicines Agencies (HMA) meeting, conducted as written procedure, March 2020
- The 100th Heads of Medicines Agencies (HMA) meeting, 28 May 2020, virtual meeting
- The Pharmacovigilance and Risk Assessment Committee (PRAC) and Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) joint meeting, 3 June 2020, virtual meeting
- Competent Authorities for Medical Devices (CAMD), 4 - 5 June 2020, virtual meeting
- Working Group of Quality Managers (WGQM), 9 - 10 June 2020, virtual meeting
- The Committee for Medicinal Products for Human Use (CHMP) and Scientific Advice Working Party (SAWP) joint meeting, 17 June 2020, virtual meeting
The most important strategic meetings were the 99th and the 100th Heads of Medicines Agencies (HMA) meetings. Due to the COVID-19 pandemic, the meetings were held in a different format:
- The 99th HMA meeting was conducted as written procedure where the members exchanged the most important updates related to the HMA work, Brexit, nitrosamine impurities in medicinal products and the BEMA evaluation programme for medicines agencies.
- The 100th HMA meeting was held as the first virtual meeting of the HMA Network. The meeting was chaired by Prof Siniša Tomić, PhD, Head of HALMED, and was focused on the functioning of the European Medicines Regulatory Network in the context of the COVID-19 pandemic. A report on the cooperation of the European Medicines Agency (EMA) and the European Commission with Member States and their activities carried out to provide EU citizens with vaccines and medicines for COVID-10 and the availability of existing therapies was provided. Meeting also included "Tour de table” where representatives of all the MS national competent authorities reported on key experiences gained during the pandemic period. Participants exchanged information on the development of therapeutic options and vaccines for COVID-19 disease, as well as on the means of monitoring shortages and market supply of medicinal products and medical devices. Additionally, participants reported on the implementation of the New Veterinary Regulation and on the progress update for the HMA-EMA joint strategy from 2020 to 2025.
The Committee for Orphan Medicinal Products (COMP) meeting covered a number of expert topics that include development, innovation and research of new medicinal products. Accordingly, the possibilities of treating rare diseases in Croatia and the availability of orphan medicinal products through the Croatian Health Insurance Fund (HZZO) were presented. Additionally, the meeting marked the COMP’s 20 years of successful work, during which significant improvements in ensuring therapeutic options for rare diseases were achieved.
The Pharmacovigilance and Risk Assessment Committee (PRAC) and Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) joint meeting included topics related to safety signals in medicines monitoring, periodic Safety Update Reports (PSURs) and Risk Minimisation Plans.
During their meeting, members of the Competent Authorities for Medical Devices (CAMD) discussed the priorities of implementation process of Regulation (EU) 2017/745, communication with industry representatives and stakeholders, and the challenges encountered in their daily work during the COVID-19 pandemic. HALMED’s representatives presented the part of the medical devices system under HALMED’s competence.
The Working Group of Quality Managers (WGQM) meeting focused on the most important experiences related to the risk management and business continuity plans gained during the COVID-19 pandemic. Additionally, meeting participants discussed topics related to the implementation of internal audits, organisation of the upcoming Benchmarking of European Medicines Agencies (BEMA) cycle and the status of the WGQM documents revision.
At the Committee for Medicinal Products for Human Use (CHMP) and Scientific Advice Working Party (SAWP) joint meeting participants were introduced to the process of development of artificial intelligence (AI) in medicine, the challenges of using the real-world data in adoption of regulatory decisions and the recommendations for the Big Data Task Force (BDTF). During the separate part of the meeting, CHMP and SAWP members discussed strategic issues related to their work.
During the Presidency, HALMED's experts participated in the preparation and alignment of working programme and meeting agendas for committees and working groups, while paying attention to topics related to the COVID-19 pandemic, the regulation and monitoring of the safety of medicinal products and medical devices, as well as topics important for ensuring available, quality and safe medicinal products and medical devices, in order to protect public health.
All news related to HALMED's activities during the Croatian Presidency are published on the HALMED's website in the News and educations and the Croatian Presidency of the Council of the European Union sections, as well as on the official website of the Croatian Presidency where all information related to the Croatian presidency and the upcoming meetings are provided.