EMA Prepares for Regulation on Health Technology Assessment

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The agency’s work with EUnetHTA 21 helped it to prepare the EU for implementation of the regulation.

The European Medicines Agency (EMA) gave an update on Sept. 15, 2023 about its work with the European Network for Health Technology Assessment (EUnetHTA 21). The consortium worked with the agency to deliver a number of milestones in preparation for the Regulation on Health Technology Assessment, which was entered into force in January 2022 and will apply as of January 2025. The regulation will “govern the European cooperation between medicine regulators and HTA bodies. Under the new framework, EMA and HTA bodies will collaborate in the context of joint clinical assessments, joint scientific consultations, and the identification of emerging health technologies,” according to EMA.

The agency noted several achievements that happened as part of its cooperation with EUnetHTA 21, including seven parallel joint scientific consultations for medicines, addressing challenges for advanced therapy medicinal products in oncology, organizing training for those involved in HTA processes, and recommending optimization of assessment reports. The EUnetHTA 21 stopped operating on Sept. 16, 2023, but implementation of the regulation will continue under the HTA Coordination Group, according to EMA. A new framework for Parallel EMA/HTA Scientific Advice from September 2023 until January 2025 has been established by EMA and HTA organizations.

“EMA’s collaboration with EUnetHTA began in 2010 as a project to test out whether early engagement between regulators and HTA bodies could bring tangible benefits for patient access to medicines,” said Michael Berntgen, head of Scientific Evidence Generation Department at EMA, in a press release. “Together, we were able to help medicine developers enhance clinical research and become more efficient in generating the evidence relevant for both regulatory authorities and HTA bodies.”


“Although the EMA-EUnetHTA cooperation is drawing to a close, the road does not end here,” said Niklas Hedberg, chair of the EUnetHTA 21 Consortium executive board, in the press release. “We are very proud to see that our cooperation has now been enshrined into European law. The experience gained provided essential technical input to shape the new legislation. In fact, we continue our joint work and will do this on a new footing, with more participants, additional responsibilities, and high expectations from stakeholders.”

Source: EMA