Joint session of CHMP and PRAC in Helsinki

The strategic review and learning meeting of CHMP-PRAC under the Finnish Presidency was held in Helsinki on 21.–23. October 2019.

In the opening words Director General of Fimea Eija Pelkonen emphasized the Finnish goals in sustainable health and medicine policies, innovation and early access to medicines, rational use of medicines and efficient processes. The main themes of the meeting were: Efficient processes, Rational use of medicines, and Innovation and early access.  Director of Fimea Esa Heinonen, the Chair of the EU Innovation Network, highlighted the innovation and early access theme in his presentation on the basis of the earlier INNO-meeting, held in Helsinki in July 2019.

The joint session of CHMP and PRAC addressed the current status of biosimilar medicines, their use and forthcoming challenges.

CHMP session

CHMP-discussions focused on optimizing the use of resources and improving the efficiency of the processes within the EU Regulatory Network. Multinational assessment teams have enabled an effective utilization of expertise involving also the smaller national competent authorities. This concept for the CHMP was initiated by Finland in 2012. Continuous improvement of the overall quality and pertinence of the assessment and reports is in the interest of EMA and every assessment team. An active peer-review process helps in achieving this goal. Also many other procedural issues were discussed.

PRAC session

PRAC meeting focused more deeply on the rational use medicines as well as pharmacovigilance of medicines during pregnancy and breastfeeding. In terms of Theme efficient processes, ideas for more effective practices for the work of the committee as well as collaboration with other committees were searched and further discussed.

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Committee for Medicinal Products for Human Use (CHMP)

Pharmacovigilance Risk Assessment Committee (PRAC)