The three years collaboration between EMA and the European Network for Health Technology Assessment consortium (EUnetHTA 21) closed on 16 September 2023. The date marks also the start of the transition period that will lead to the full implementation of the HTA Regulation on 1 January 2025. During the next 15 months, the new framework for Parallel EMA/HTA Scientific Advice will be in place to support developers requesting the involvement of HTA bodies when applying for EMA scientific advice. This temporary procedure will lead to the issuing of a scientific advice letter by EMA and individual written recommendations from participating HTA bodies. Other priorities identified by EMA to prepare to the HTA regulation include defining a single evidence plan to facilitate development programmes, harmonising views on the strength of the evidence, and involving patients, clinical experts and other relevant experts in decision-making
“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”, said Niklas Hedberg, Chair of the EUnetHTA 21 Consortium Executive Board.