HTA Regulation: Regulation (EU) 2021/2282 on health technology assessment
The HTA Regulation, Regulation (EU) 2021/2282, sets up EU joint clinical assessments and joint scientific consultations for medicines from 2025.
Regulation (EU) 2021/2282 on health technology assessment entered into force in January 2022 and applies from 12 January 2025. It creates a Member State Coordination Group on HTA, joint clinical assessments (JCAs) of new medicines, joint scientific consultations for developers, and horizon scanning. The scope is phased: medicines with new active substances for cancer and advanced therapy medicinal products from 12 January 2025, orphan medicinal products from 13 January 2028, and all other centrally authorised medicines from 13 January 2030. Medical devices in the highest risk classes follow later selection decisions. The Regulation replaced the voluntary EUnetHTA cooperation that had run since 2006 with a permanent legal framework.
A JCA covers the clinical domains only: the relative effectiveness and safety of the medicine against the comparators and populations the Member States ask about. It does not reach a conclusion on added value and says nothing about price. Non-clinical domains such as economic, ethical and organisational aspects remain national, as do pricing and reimbursement decisions. Member States must give due consideration to the JCA report and may not ask the developer to resubmit the same evidence at national level, which is the main efficiency the Regulation offers.
For the developer, the Regulation adds a second dossier that runs in parallel with the EMA assessment. The scope is defined through PICO questions (population, intervention, comparator, outcomes) that gather the needs of all Member States, so one product can face many comparators at once. Implementing Regulation (EU) 2024/1381 sets out the JCA procedure and the dossier format. Joint scientific consultations, which can be run in parallel with EMA scientific advice, let developers test trial designs against what the HTA bodies will later want to see.
What goes wrong: trial programmes designed years ago that cannot answer a PICO comparator common in Europe, dossiers that are not ready when the JCA request lands during the centralised procedure, and market access teams that treat the JCA as a formality rather than the main clinical evidence review their national negotiations will build on. Regulatory affairs is affected because the authorised indication wording and the product information must line up with the JCA scope, and because a later extension of indication can trigger an update of the joint assessment.
Timing
The JCA runs alongside the centralised procedure. The developer receives the scope and submits the JCA dossier before the CHMP opinion, with the Regulation requiring the dossier no later than 45 days before the date envisaged for the opinion. Assessors and co-assessors draft the report during the EMA procedure, and the Coordination Group endorses and publishes the JCA report within 30 days of the Commission decision on the marketing authorisation. National pricing and reimbursement procedures then proceed on their own clocks.
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Market access and regulatory teams follow HTA Coordination Group publications and scope changes with Alerts.
Related terms
- JCA: joint clinical assessmentA joint clinical assessment (JCA) is the EU-level review of a new medicine's relative effectiveness under the HTA Regulation, shared by all Member States.
- Pricing and reimbursement: national decisions on price and public fundingPricing and reimbursement are the national decisions, taken after authorisation, that set a medicine's price and whether a health system pays for it.
- Centralised procedure: single EU marketing authorisation via EMAThe centralised procedure grants one marketing authorisation valid across the EU and EEA after a single EMA assessment and a Commission decision.
- Scientific advice: EMA or national guidance on development before submissionScientific advice is formal guidance from EMA or a national authority on the studies and data a developer should generate before applying for an MA.
- ATMP: advanced therapy medicinal productAn advanced therapy medicinal product (ATMP) is a gene therapy, somatic cell therapy or tissue-engineered medicine under Regulation (EC) No 1394/2007.
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