EMA, HTA consortium prep for HTA regulation coming into effect

The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) 21 consortium have outlined the next stages of their preparation for the EU Regulation on Health Technology Assessment.

The organizations shared details this week in a new work plan covering efforts through 2023, explaining that the overall aim is to find synergies that facilitate patients’ access to innovative medicines in the European Union (EU).

EMA said, “The focus of the plan is to prepare, from a methodological and operational perspective, for the coming into application of the Regulation on Health Technology Assessment (EU) 2021/228 in January 2025.”

Scientific advice

The joint work plan establishes various priority areas including the finalization of a single process for scientific consultation with HTA bodies and EMA. The aim is to provide developers with advice on the generation of patient-relevant data.

The current procedure for joint scientific consultation by HTA bodies in parallel with scientific advice by EMA – previously known as parallel scientific advice or parallel consultation or Early Dialogue – was relaunched in March.

It is designed to allow medicine developers to discuss plans for evidence generation for a medicine with both regulators and HTA bodies, including the approach the developer will use for post-licensing evidence generation.

Information exchange and engagement

The joint work plan also covers how and when regulatory assessors and HTA bodies should exchange information on products of mutual interest, including advanced therapy medicinal products (ATMPs).

For example, in addition to working together to identify relevant products, EMA and EUnetHTA will arrange discussions about ATMPs, in line with measures suggested in the EC / EMAs action plan published in 2017.

The organizations have also agreed to explore the feasibility of earlier engagement between regulators and HTA bodies during regulatory assessments through a voluntary pilot program for early engagement.

The organizations write that, “Earlier engagement between regulators and HTA bodies should support the uptake of innovation in healthcare systems for the benefit of patients across Europe.”

EMA and EUnetHTA will also work to improve interaction with patients, physicians and experts by developing guidelines on engagement methodologies.

The aim is to “deepen the mutual experience / exchange on the involvement of patients and healthcare professionals in activities with focus on challenges of mutual interest,” according to the document.

To that end, the organizations have agreed to “exchange contacts for identification of experts for HTA and EMA activities.” They will also try to create a process / information package to help experts understand the differences between HTA and regulatory activities.


EMA and EUnetHTA began collaborating in 2010 in response to the recommendations from the High Level Pharmaceutical Forum. The initial objective was to improve the contribution of European Public Assessment Report (EPARs) to the assessments of relative effectiveness of pharmaceuticals by the HTA bodies.

The first joint work plan – which covered 2012 to 2015 – focused on creating “synergies between regulatory evaluation and health technology assessment (HTA) along the lifecycle of a medicine.”

And, according to a report published in 2016, progress was made on the provision of scientific advice / early dialogue for medicine developers. A second work plan saw EMA and EUnetHTA expanded the collaboration to post launch scientific advice.

In addition, according to a report published last June, the second work plan also saw the organizations fine-tune the information exchange framework established during the previous phase.


The Health Technology Assessment regulation – which was adopted last December – is designed to make innovative health technologies, such as medicines, medical devices, equipment and other treatments more widely available.

It is also intended to make the use of resources more efficient, strengthen the quality of HTA across the EU, and save national HTA bodies and industry from duplicating their efforts, reassure business and ensure the long-term sustainability of EU HTA cooperation.

The regulation is due to come into application in 2025 after a three-year implementation period.

EMA said, “Following the award of a service contract to the EUnetHTA 21 consortium to support the continuation of EU cooperation on HTA, the European Commission invited EMA and EUnetHTA 21 to establish a joint work plan to be carried out during the transition phase in order to deliver on key areas of their collaborative work. ”

© 2022 Regulatory Affairs Professionals Society.

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