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Transition to EU HTA – Consequences of an existence of national and EU HTA in parallel

Overview of our services Strategic advice   Regulation (EU) 2021/2282 Article 7 (1) of Regulation (EU) 2021/2282 specifies when a health technology must undergo a Joint Clinical Assessment (JCA). Paragraph 1a stipulates that the time of initial market authorization application (MAA) is decisive. A JCA of the new health technology only needs to be

2024-04-19T12:58:28+02:0019. February 2024|European HTA|0 Comments

Challenges and Chances of the EU-HTA

The first medicinal products used to treat oncologic diseases and ATMPs will be assessed within the framework of the Joint Clinical Assessments on the level of the European Union (EU) starting in 2025. Until then, the necessary health technology assessment (HTA) process needs to be defined and refined. Today, we were honored to present our

2022-04-05T15:02:46+02:0023. February 2022|European HTA|0 Comments

EU-HTA: Regulation 2021/2282 is effective starting today

The Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment (HTA) and amending Directive 2011/24/EU is effective starting today, 11 January 2022. Click for more information>>> The Regulation aims to establish joint clinical assessments of health technologies in the European Union (EU) starting with oncologic

2022-04-05T15:02:46+02:0011. January 2022|European HTA, HTA Services|0 Comments

EU-HTA: Adoption of the Regulation

On Dec 13th, 2021, the Regulation on Health Technology Assessment (HTA) has officially been adopted. The new Regulation aims to establish a system for joint clinical assessments of health technologies in the European Union. First assessments of oncologic drugs and ATMPs start in 2025, followed by orphan drugs three years later in 2028 and medicinal

2022-04-05T15:02:46+02:0021. December 2021|European HTA, HTA Services|0 Comments

EUnetHTA 21 – Open call for Joint Scientific Consultations

This month, the European Council adopted the regulation on the EU-wide assessment of health technologies (EU-HTA). At the same time, the first call for applications is now open for scientific advice within the framework of EUnetHTA. In the open call of the EUnetHTA 21 JSC Secretariat, pharmaceutical companies can apply for parallel consultations with the

2022-04-05T15:02:46+02:0017. November 2021|European HTA|0 Comments
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