As part of the Hungarian Presidency of the Council of the EU, the 118th meeting of the Heads of Medicines Agencies (HMA) was hosted in Budapest, Hungary on 5–6 December. Founded in 1996, HMA comprises the leaders in the pharmaceutical industry from the 27 EU Member States, the four EFTA countries, and the United Kingdom. Leaders of the European Medicines Agencies Cooperation on Legal and Legislative Issues (EMACOLEX) were also present at the meeting, the Hungarian EU Presidency’s official website reports.

The gathering convened legal specialists from the European Medicines Regulatory Network (EMRN) as well, alongside senior representatives from the relevant national authorities. The objective of the meeting was to further tackle essential legal and regulatory matters crucial for both human and veterinary medicine within the European Economic Area (EEA). Attendees participated in thorough discussions on significant issues related to the regulation of medicines intended for human use throughout Europe.

The focus of the agenda was on the latest advancements in EU pharmaceutical legislation, regulatory hurdles, shortages of medicines, the quality of pharmaceuticals, and effective methods for aligning legal frameworks among member countries. Additionally, new concerns regarding digital health and data privacy, along with regulatory structures for innovative therapies, were discussed.

The meeting was a significant chance for representatives from national competent authorities (NCAs) to synchronize their strategies, exchange their experiences, and work together in addressing shared challenges, thereby ensuring that the aspects of medicine regulation stay coherent, transparent, and supportive of regulatory objectives.

By encouraging open communication and collaboration during the joint meeting, the participants reinforced their mutual understanding, built trust, and improved their ability to safeguard public health throughout the European Union.

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