{"id":7952,"date":"2025-01-20T13:20:50","date_gmt":"2025-01-20T13:20:50","guid":{"rendered":"https:\/\/els-solutions.com\/cms\/dev\/?p=7952"},"modified":"2025-01-20T13:19:54","modified_gmt":"2025-01-20T13:19:54","slug":"eu-regulation-2021-2282-on-health-technology-assessment-enters-into-force","status":"publish","type":"post","link":"https:\/\/els-solutions.com\/en\/eu-regulation-2021-2282-on-health-technology-assessment-enters-into-force\/","title":{"rendered":"EU Regulation 2021\/2282 on Health Technology Assessment Enters into Force"},"content":{"rendered":"

On January 12, the EU Regulation 2021\/2282<\/strong> on Health Technology Assessment (HTA) came into effect. This regulation marks a significant milestone in ensuring that patients across the European Union have access to innovative and effective health technologies, such as medicines and medical devices.<\/p>\n

Get to know the Health Technology Assessment Regulation<\/h3>\n

The new HTA rules stem from over 20 years of voluntary collaboration among EU Member States. Their goal is to support national authorities in decision-making about funding health technologies while harmonizing procedures at the European level.<\/p>\n

From now on, the clinical assessment of each health technology will be conducted jointly, making the process more efficient and accelerating patient access to new health products.<\/p>\n

The Role of INFARMED and Its Commitment to the New System<\/h3>\n

Portugal’s regulatory authority, INFARMED, I.P.<\/strong>, played an active role in shaping this system, contributing through its participation in the European Network for Health Technology Assessment (EUnetHTA)<\/strong>.<\/p>\n

INFARMED’s involvement was pivotal in securing the agreement that led to the regulation\u2019s approval during Portugal\u2019s Presidency of the EU in 2021. Currently, INFARMED remains actively engaged in the Health Technology Coordination Group (HTACG)<\/strong>, holding prominent roles such as co-chair of the Subgroup on Assessment Methodologies<\/strong> and chair of the Heads of HTA Agencies (HAG)<\/strong> group.<\/p>\n

This commitment highlights INFARMED\u2019s dedication to the implementation of this new system. Moreover, under the National System for Health Technology Assessment (SiNATS)<\/strong>, INFARMED will actively participate in clinical assessments and joint scientific consultations at the European level, contributing to the establishment of a robust and efficient system that supports national decision-making.<\/p>\n

Applicable Rules and Business Implications<\/h3>\n

For companies seeking authorization to enter the EU market, the new rules will be governed by a permanent HTA framework.<\/p>\n

This framework introduces a single submission dossier<\/strong> for joint clinical assessments, eliminating duplication of efforts and ensuring resource efficiency and scientific quality in HTA.<\/p>\n

Separately, the FDA is working on guidelines to ensure the credibility of artificial intelligence models to foster safe and effective innovations in the healthcare sector.<\/p>\n

<\/h3>\n

What are the next steps?<\/h3>\n

Starting January 12, the new rules apply to marketing authorization applications for new oncology drugs and advanced therapy medicinal products (ATMPs).<\/p>\n