The new Regulation (EU) 2021/2282 on Health Technology Assessment

Last updated: 27 September 2025

This post is an attempt to provide basic information on Health Technology, its assessment and the new Regulation (EU) 2021/2282.

Click on the ‘+’ sign next to each heading to access the information under each heading. Repitition of information throughout has been done intentionally.

DateUpdate(s)
27 Sep 2025In the section Meeting outcomes from various groups, added link to Flash report – Member State Coordination Group on HTA (HTACG) (25 September 2025)
9 Sec 2025The following new sections were added:
-What is a Joint Clinical Assessment (JCA) ?
-What is a Joint Scientific Consultation (JSC)?
5 Sep 2025New section FAQ added with a link to the FAQ document version 1 of September 2025.
2 Sep 2025In the section Meeting outcomes from various groups, a link to the item Summary minutes – HTA Stakeholder Network (1 July 2025) was added.
11 Aug 2025Added the following new sections:
i) What products are covered by the Joint Clinical Assessment?
ii) How to identify products subject to a Joint Clinical Assessment (JCA) from 2025, declare in the EMA Letter of Intent whether an application falls under the scope of the Health Technology Assessment Regulation ((EU) 2021/2282 Article 7, who else to notify and the notification process
27 Jul 2025i) In the section Is there a rolling plan available for the implementation of the HTA Regulation? link provided to updated rolling plan of 25 Jun 2025.
ii) In the section Meeting outcomes from various groups, added minutes from the HTACG – Subgroup for Joint Scientific Consultations of 11 Jun 2025.
iii) New section titled Factsheets on Implementation of the HTA regulation, Joint scientific consultations and joint clinical assessments added.
8 Jul 2025i) Section heading Webinars and other video clips amended to Webinars, other video clips, conferences, events etc.
ii) Information and links added to the conference of 2 July 2025 entitled EU health technology assessment: Advent of a new era of collaboration.
29 May 20251) Section Implementing acts updated to add information on a new online public consultation.

3) New section Second submission period for joint scientific consultations (JSCs) added.
28 May 2025Section Meeting outcomes from various groups updated to add a link to a Flash report from the Member State Coordination Group on HTA (HTACG) 22 May 2025).
21 May 2025The Webinars and other video clips section was updated to add a link to the Webinar of 16 May 2025.
1 Apr 2025In the section Webinars and other video clips, link added to the webinar and presentation 21 March 2025 titled The EU HTA Regulation: Webinar for health technology developers of medicinal products.
23 Mar 2025In the section Webinars and other video clips, added links to the following:
1) A link to a video clip (Jan 2025) titled Understanding the EU Health Technology Assessment Regulation from European Patients Academy on Therapeutic Innovation
2) A link to the presentation from the webinar of 21 March 2025 titled The EU HTA Regulation: Webinar for health technology developers of medicinal products
4 Mar 2025In the section Meeting outcomes from various groups, link added to Flash report from the Member State Coordination Group on HTA (HTACG) (28 February 2025)
6 Feb 2025Added new section EU Health Technology Assessment Regulation 2021/2282 – A pan-European guide to better preparedness. The guide has very useful information by country.
4 Feb 20251) New section First request submission period for joint scientific consultations opened added.
2) In the section Meeting outcomes from various groups, added link to Summary minutes from the 4th Meeting of the Health Technology Assessment Stakeholder Network 29 November 2024.
29 Jan 2025Under the section Implementing acts, added a link to Commission Implementing Regulation (EU) 2025/117 of 24 January 2025 laying down rules for the application of Regulation (EU) 2021/2282 with regard to the procedures for joint scientific consultations on medical devices and in vitro diagnostic medical devices  
24 Jan 20251) The title of the section Webinar was updated to Webinar and other video clips
2) The information in the section was tabulated.
3) A link to a new video clip titled New rules on Health Technology Assessment was added.
4) Updated the table in the section Implementing acts to confirm the adoption of the an implementing regulation establishing the rules for joint scientific consultations on medical devices and in vitro diagnostic medical devices, under the Health Technology Assessment (HTA) Regulation.     
10 Jan 20251) Section Is there a rolling plan available for the implementation of the HTA Regulation? updated to provide link to latest rolling plan of 10 Jan 2025.

2) Section Important dates updated to add the following information:
i) 10 Jan 2025, Press release published. Link provided.
ii) 2026 – Selected high-risk medical devices will be assessed.

3) New section Q&A on the new Health Technology Assessment added, with link to Q&A provided.
24 Dec 20241) Table in Section Implementing acts updated to add information on the adoption of the Commission Implementing Regulation (EU) 2024/3169 of 18 December 2024 laying down rules for the application of Regulation (EU) 2021/2282 of the European Parliament and of the Council with regard to the procedures for joint scientific consultations on medicinal products for human use at Union level.

2) Added Reference 8 Implementation of the Regulation on health technology assessment in the References section
3 Dec 2024New section 2025 Work Programme (HTACG) added.
2 Dec 2024In the section Meeting outcomes from various groups, link added to Flash report – Member State Coordination Group on HTA (HTACG) (28 November 2024)
19 Nov 2024New section added entitled Webinars
2 Nov 2024Table in Section Implementing acts updated to add information and link to Commission Implementing Regulation (EU) 2024/2745 of 25 October 2024
29 Oct 2024Table in Section Implementing acts updated to add information on Public consultation: Implementing Regulation on joint scientific consultations on medical devices and in vitro diagnostic medical devices at Union level
25 Oct 2024Table in Section Implementing acts updated to add information on the adoption of the implementing regulation that sets out the rules for the management of conflicts of interest of those involved in joint clinical assessments and joint scientific consultations under the Health Technology Assessment (HTA) Regulation.
24 Oct 2024Table in section Implementing acts updated to add link to the published Commission Implementing Regulation (EU) 2024/2699, the second of six implementing regulations of the Regulation on Health Technology Assessment (Regulation (EU) 2021/2282). 
18 Oct 2024Table in Section Implementing acts updated to add information on the adoption of the implementing regulation which sets out the rules for cooperation with the European Medicines Agency in the joint work carried out under the Health Technology Assessment (HTA) Regulation.
2 Oct 2024Table in section Implementing acts updated to add information on ongoing public consultation: Implementing Regulation on joint scientific consultations on medicinal products for human use at Union level
28 Sep 2024Link in the section Is there a rolling plan available for the implementation of the HTA Regulation? updated to the rolling plan of September 2024.
24 Sep 2024Section Guidance and other documents to add link to the document Guidance on the validity of clinical studies for joint clinical assessments.
20 Sep 2024In the section Meeting outcomes from various groups, link added to Flash report from the 10th meeting of the Member State Coordination Group on HTA (HTACG) 19 September 2024.
21 Aug 2024In the section Meeting outcomes from various groups, link added to Summary minutes from the 3rd Meeting of the Health Technology Assessment Stakeholder Network (11 June 2024)
27 Jun 2024In the section Implementing acts, information added on consultation concerning the third of six acts with the title below.

COMMISSION IMPLEMENTING REGULATION (EU) …/…
of XXX laying down, pursuant to Regulation (EU) 2021/2282 of the European Parliament and of the Council, detailed procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment and the Commission with the
European Medicines Agency in the form of exchange of information as regards the joint clinical assessment of medicinal products and medical devices and in vitro diagnostic medical devices and as regards the joint scientific consultation on medicinal products and medical devices
21 Jun 20241) Title of Section Guidance updated to Guidance and other documents.
2) Added link to document entitled Joint clinical assessment of medicinal products: Submission of early information by health technology developers published 21 June 2024.
14 Jun 2024New section Guidance Documents added.
12 Jun 2024New section Meeting outcomes from the Member State Coordination Group on Health Technology Assessment (HTACG) added.
30 May 2024New section entitled Implementing acts added.
23 May 2024Section Important dates updated with information from a news announcement from the Commission.
3 March 20241) Administrative changes to improve readability of the post.
2) New section Important dates added
3) Item 3 added in the section Further Information
16 Feb 2024In the section Is there a rolling plan available for the implementation of the HTA Regulation? link updated to plan of Feb 2024.
9 Feb 2024Item 3, a link to a stakeholder meeting added under the heading Further Information.
24 Oct 2023Heading Is there a rolling plan available for the implementation of the HTA Regulation? added, plus relevant content.
5 Oct 2023Under the section Further Information, link added to Factsheet on the implementation of the HTA regulation (5 October 2023)

Health technology is a diverse field covering for example medicines like new cancer drugs, medical devices like artificial hips and heart valves and other health interventions like new surgical procedures. 1

New health technologies are often complex and expensive, which is why it’s important to be able to make informed decisions before investing in them. 

This is what Health Technology Assessment (HTA) does:1

  • It summarises information about clinical, economic, social and ethical issues related to the use of a health technology in order to help Member States make decisions based on evidence.1 
  • In doing so, it also helps ensure that health care is accessible, sustainable and of high quality.1
  • HTA answers clinical questions like: “How well does the new technology work compared with existing alternative health technologies”? It can also answer economic questions like “What costs are entailed for the health system”? HTA is therefore a key tool for Member States to ensure the quality, accessibility and sustainability of healthcare.2

The new Regulation (EU) 2021/2282 on Health Technology Assessment entered into force on 11 January 2022 and it became applicable from 12 January 2025.6

This Regulation replaces:4

  • the current system based on the voluntary network of national authorities (HTA Network), and
  • the EU-funded project-based cooperation (Joint Actions EUnetHTA)

with a permanent framework for joint work that will also cover:

  • joint clinical assessments,
  • joint scientific consultations,
  • the identification of emerging health technologies, and
  • voluntary cooperation.

More information is provided on EUnetHTA elsewhere in this post.

EUnetHTA started in 2005 as a group of 35 organisations throughout Europe, led by the Danish Centre for HTA (DACEHTA) in Copenhagen which led to the activities of the EUnetHTA Project.

The mission of EUnetHTA was to support collaboration between European HTA organisations that brings added value to healthcare systems at the European, national, and regional level.

EUnetHTA was the preferred facilitator of high-quality HTA collaboration in Europe. HTA agencies considered EUnetHTA an efficient way of collaborating.

The EMAs collaboration EUnetHTA 21 EMA began in 2010 as a project to test out whether early engagement between regulators and HTA bodies could bring tangible benefits for patient access to medicines. Together, they were were able to help medicine developers enhance clinical research and become more efficient in generating the evidence relevant for both regulatory authorities and HTA bodies.5

Over the past three years, EMA and the EUnetHTA 21 consortium have delivered a number of milestones to prepare the EU for the entry into application of the Regulation on Health Technology Assessment.5

EUnetHTA 21 ceased to operate on 16 September 2023, but preparations will continue for the implementation of the Regulation, under the direction of the HTA Coordination Group.4

The regulation will govern the European cooperation between medicine regulators and HTA bodies.

  • Under the new framework, the European Medicines Agency (EMA) and HTA bodies will collaborate in the context of:
    • joint clinical assessments,
    • joint scientific consultations, and
    • the identification of emerging health technologies.
  • The HTA Regulation focuses on clinical aspects of HTA.1
  • Under the new Regulation, Member States HTA bodies will conduct Joint Clinical Assessments of new medicines and certain high-risk medical devices to e.g. compare new and existing technologies, looking at their relative clinical effectiveness and relative clinical safety.1 
  • They will also take part in Joint Scientific Consultations, to advise technology developers on clinical study designs that generate evidence for decision-making.1
  • In addition, “horizon scanning” exercises will identify promising health technologies early, to help health systems prepare for them.1
  • The above is the mandatory scope of the Regulation, but Member States may also cooperate further voluntarily, for example on health technologies other than medicines and medical devices, or on economic aspects of HTA.1
  • While aiming to improve the availability of innovative medicines and certain medical devices for patients in the EU, it will also ensure efficient use of resources and enhance the quality of health technology assessment in the EU by ensuring the sustainability of European cooperation.
  • The establishment of the Member State Coordination Group on Health Technology Assessment, as provided by the regulation, and of a stakeholder network, will give a transparent and inclusive framework to facilitate continued collaboration between partners and reduce duplication of efforts for national HTA authorities and industry.
1. Member States
  • Will be able to pool their HTA resources and expertise.
  • Joint Clinical Assessments will be high quality, timely scientific reports that Member States will take into consideration in their national HTA processes.
  • In this way, the Regulation will support Member States in taking more evidence-based and timely decisions on patient access to new medicines and medical devices. 
2. Patients

Patients will be empowered and clinicians better informed by having access to Joint Clinical Assessment reports that are of high scientific quality, transparent and accessible to the public.

3. Pharmaceutical and medical device industries
  • Developers in the pharmaceutical and medical device industries will have more clarity and predictability concerning the clinical evidence requirements for HTA.
  • Industry will also benefit from efficiency gains when submitting clinical evidence for HTA, since there will be only a single EU-level submission file for Joint Clinical Assessments (rather than, as in the past, multiple parallel submissions to the different national HTA systems).

The EMA and HTA organisations established a new framework for Parallel EMA/HTA Scientific Advice for the period from 17 September 2023 until 12 January 2025, when the HTA Regulation became applicable. During this transition period:5

Yes there is.

The rolling plan contains a list of key activities that the Commission has carried out or intends to carry out in preparation for the implementation of Regulation 2021/2282 on Health Technology Assessment (the “HTAR”). The plan is subject to regular review to provide national authorities and stakeholders with the most updated information.

You can view the plan (last updated 25 June 2025) here.

Date
11 Jan 2022The new Regulation (EU) 2021/2282 on Health Technology Assessment entered into force.6
23 May 2024Today, the European Commission adopted new rules for the joint clinical assessments of medicines at Union level, contributing to faster access to medicines for EU patients.
-These new rules define the timelines and the steps for conducting EU joint clinical assessments.
-The assessment reports will provide scientific evidence to Member States’ authorities at an early stage after a medicine’s marketing authorisation. This will help them to decide about its use in the national health system, assessing their value on the basis of robust evidence, and thus taking more effective, timely decisions when bringing medicines to the market.
-The rules are adopted under the Regulation on Health Technology Assessment (HTA). This Regulation established a new, innovative approach to harness and pool expertise from across the EU for assessing the effectiveness of new medicines compared to medicines already in use, while supporting healthcare systems to provide quality care for the EU using the latest technologies.
-Today’s rules are the first of six acts to be adopted this year under the HTA Regulation.
-Joint clinical assessments will start as of January 2025 for medicinal products with new active substances for the treatment of cancer and for advanced therapy medicinal products.

Further information is available at the link below.

Source: European Commission
10 Jan 2025A press release entitled New EU rules on Health Technology Assessment open up a new era for patient access to innovation was published.
12 Jan 2025The new HTA regulation became applicable from 12 January 2025.6

New oncology medicines and Advance Therapy Medicinal Products will be assessed at EU level from this date.7
2026Selected high-risk medical devices will be assessed.
13 Jan 2028Orphan medicinal products to be added to the joint work.7
13 Jan 2030All new medicines will come under the scope of the regulation.7

The HTA Regulation foresees the adoption of implementing acts, detailing the procedural rules for the different elements in the Regulation. Further information is provided in the table below:

Implementing RegulationsCurrent status
Commission Implementing Regulation (EU) 2024/1381 of 23 May 2024 laying down, pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medicinal products for human use at Union level, as well as templates for those joint clinical assessments

This is the first of six acts which must be adopted before 12 January 2025, the date of application of the HTA Regulation.		Adopted by the Commission on 23 May 2024
Commission Implementing Regulation (EU) 2024/2699 of 18 October 2024 laying down, pursuant to Regulation (EU) 2021/2282 of the European Parliament and of the Council, detailed procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment and the Commission with the European Medicines Agency in the form of exchange of information as regards the joint clinical assessment of medicinal products and medical devices and in vitro diagnostic medical devices and as regards the joint scientific consultation on medicinal products and medical devices

These rules define the information to be shared: 
• for planning and forecasting of joint clinical assessments and joint scientific consultations;
• for identifying patients, clinical experts and other relevant experts to be involved in these joint procedures; and
• on general scientific and technical matters related to health technology assessment.

The Implementing Regulation also concerns the security of sharing and protection of confidential information exchanged between the European Medicines Agency and the HTA secretariat within the Commission, and with the Member State Coordination Group on HTA and its subgroups.  

This is the second of six acts which must be adopted before 12 January 2025, the date of application of the HTA Regulation.		Adopted by the Commission on 18 October 2024
Commission Implementing Regulation (EU) 2024/2745 of 25 October 2024 laying down rules for the application of Regulation (EU) 2021/2282 of the European Parliament and of the Council as regards the management of conflicts of interest in the joint work of the Member State Coordination Group on Health Technology Assessment and its subgroups

These rules aim to ensure that EU-level assessments of new health technologies are conducted in an independent, impartial and transparent manner, free from conflicts of interest.
In particular, the rules provide an assessment framework for exclusions from and limitations to participation in the joint work on HTA, based on the declared interests.

These rules will apply to all parties taking part in joint clinical assessments and joint scientific consultations, including representatives in the Member State Coordination Group and its subgroups, the appointed assessors, co-assessors and patients, clinical experts and other relevant experts involved in these joint procedures.

This is the third of six acts which must be adopted before 12 January 2025, the date of application of the HTA Regulation.		Adopted by the Commission on 25 October 2024
Commission Implementing Regulation (EU) 2024/3169 of 18 December 2024 laying down rules for the application of Regulation (EU) 2021/2282 of the European Parliament and of the Council with regard to the procedures for joint scientific consultations on medicinal products for human use at Union level

The implementing act provides detailed procedural rules for the joint scientific consultations, also known as scientific advice, covering:
• the submission of requests from health technology developers;
• the selection and consultation of stakeholder organisations and patients, clinical and other relevant experts;
• cooperation with the European Medicines Agency (EMA) where a health technology developer requests a joint scientific consultation to be carried out in parallel with EMA’s scientific advice process.

This is the fourth implementing act adopted under the HTA Regulation.		Adopted by the Commission on 18 December 2024
Commission Implementing Regulation (EU) 2025/117 of 24 January 2025 laying down rules for the application of Regulation (EU) 2021/2282 with regard to the procedures for joint scientific consultations on medical devices and in vitro diagnostic medical devices  

The implementing act provides detailed procedural rules for the joint scientific consultations, also known as scientific advice, covering:
• the submission of requests from health technology developers;
• the selection and consultation of stakeholder organisations and patients, clinical and other relevant experts;
• cooperation with the European Medicines Agency (EMA) where a medical device developer requests a joint scientific consultation to be undertaken, in parallel with an expert panel consultation.

This is the fifth implementing act adopted under the HTA Regulation.		Adopted by the commission on 24 January 2025
Public consultation on joint clinical assessments of medical devices and  in vitro diagnostic medical devices at Union level under the HTA Regulation

On 28 May 2025, the European Commission launched an online public consultation on joint clinical assessments of medical devices and in vitro diagnostic medical devices at Union level under the HTA Regulation. It sets out implementing rules to ensure that EU-level assessments are conducted in good time and that the relevant experts are involved or consulted.

This public consultation is focussed on the last implementing act for adoption under the HTA Regulation, which will complete the legislative framework for its implementation. Your contribution can provide important information and insights on the implementation of the Regulation.

Source: EU Commission, eNews		This online consultation was open for responses from 28 May 2025 until 25 June 2025.

DateDocument titleAbout the document
23 Sep 2024Guidance on the validity of clinical studies for joint clinical assessmentsThis guidance helps to define, classify, and assess the certainty of clinical study results in an objective, reproducible and transparent way. It covers the analysis of data from different types of single clinical studies.

This guidance complements the guidance documents previously adopted by the Member State Coordination Group on outcomes for joint clinical assessments, on quantitative evidence synthesis for direct and indirect comparisons and on reporting requirements for multiplicity issues and subgroup, sensitivity and post hoc analyses in joint clinical assessments.

Source: European Commission
21 Jun 2024Joint clinical assessment of medicinal products: Submission of early information by health technology developersThis document is a good starting point to find out basic information about HTAs and procedural aspects.
13 Jun 2024Guidance on outcomes for
joint clinical assessments		This guidance will help:
-Member States’ authorities define the scope of the assessments
-assessors report all the elements that Member States need for the national appraisal of the clinical added value of health technology. 
13 Jun 2024Guidance on reporting requirements for multiplicity issues and subgroup, sensitivity and post hoc analyses in joint clinical assessmentsThis guidance describes how assessors should deal in practice with multiplicity issues and complementary analyses in joint clinical assessment (JCA) reports. 
13 Jun 2024Scientific specifications of medicinal products subject to joint clinical assessmentsThis information document made available to clarify the scientific specifications of ‘new active substance’ and ‘therapeutic indication of treatment of cancer’ to determine if a medicinal product shall be subject to joint clinical assessment (JCA) between 12 January 2025 and 13 January 2030.

You can view the factsheets at the links below:

Source: European Commission (Joint Scientific Consultations) , EU Commission (Joint Clinical Assessments)

You can view the Q&A dated 10 January 2025 here.

Source: European Commission

Version 1 of the FAQ document was published on 5 September 2025. You can view it here.

Source: European Commission

DateItem and Title
27 Sep 2025Flash report – Member State Coordination Group on HTA (HTACG) (25 September 2025)
2 Sep 2025Summary minutes – HTA Stakeholder Network (1 July 2025)
11 Jun 2025HTACG – Subgroup for Joint Scientific Consultations minutes.
28 May 2025Flash report from the Member State Coordination Group on HTA (HTACG) 22 May 2025)
4 Mar 2025Flash report from the Member State Coordination Group on HTA (HTACG) (28 February 2025)
4 Feb 2024Summary minutes from the 4th Meeting of the Health Technology Assessment Stakeholder Network 29 November 2024
21 Aug 2024Summary minutes from the 3rd Meeting of the Health Technology Assessment Stakeholder Network 11 June 2024
10 Jun 2024 Flash report from the 9th Meeting of the Member State Coordination Group on HTA (HTACG) 10 June 2024.
20 Sep 2024Flash report from the 10th meeting of the Member State Coordination Group on HTA (HTACG) 19 September 2024
2 Dec 2024Flash report – Member State Coordination Group on HTA (HTACG) (28 November 2024)

Source: European Commission

You can view Version 1.0 of the 2025 Work Programme – Member State Coordination Group on HTA (HTACG) (dated 28 Nov 2024) here.

DateItemFurther informatiom
2 Jul 2025Conference/EventEU health technology assessment: Advent of a new era of collaboration

This hybrid event takes stock of the implementation of the EU Health Technology Assessment Regulation (HTAR) half-way into its first year of application. The conference also sought to explore the broader implications of HTAR on EU Member States and the global HTA landscape.

Links to the conference programme, the video recordings and the presentations are available at the link below.

Source: European Commission
16 May 2025WebinarHealth technology assessment: Webinar for patients and clinical experts

In this webinar, the process for joint clinical assessments and joint scientific consultations is explained. The webinar focused on how patients (or their carers) and clinical experts can be involved in these processes. 
In addition, there was a presentation of the HTA IT Platform, demonstrating how to fill in the declaration of interests and how to provide input to specific assessments or consultations via the IT Platform. 
21 Mar 2025Webinar
Webinar and Presentation – The EU HTA Regulation: Webinar for health technology developers of medicinal products
23 Jan 2025video clipThis clip titled New rules on Health Technology Assessment provides very basic information about Health Technology assessment.

Source: DG Health and food safety
Jan 2025Video clipUnderstanding the EU Health Technology Assessment Regulation (HTAR) (European Patients Academy on Therapeutic Innovation)
15 Nov 2024Webinar

Source: European Commission		Here is a link to The EU HTA Regulation: Webinar for health technology developers of medicinal products

• In this webinar, the Chairs and Co-chairs of the Member State Coordination Group on Health Technology Assessment and its subgroups explain the process for joint clinical assessments and joint scientific consultations.

•The  webinar is targeted at representatives of health technology developers of medicinal products.

The new rules are introducing a staged approach towards all medicinal products seeking centralised marketing authorisations.

DateProduct(s) covered
Starting 12 January 2025As a first step, starting on 12 January, a marketing authorisation application for a new cancer medicine or an advanced therapy medicinal product, which is validated by the European
Medicines Agency, will trigger a joint clinical assessment under the authority of the Member State Coordination Group on Health Technology Assessment.
From 2026Selected high-risk medical devices will also be assessed as of 2026
From 13 January 2028The rules will be extended to orphan medicinal products in January
2028.
From 13 January 2030The rules will be extended cover all new medicinal products.

Source: Q&A from the European Commission

A Joint Clinical Assessment (JCA) is the scientific compilation and description of a comparative analysis of the available clinical evidence on a health technology.

This analysis compares the technology with one or more other existing health technologies or existing procedures, in accordance with an agreed-upon “assessment scope”.

The assessment scope defines the parameters in terms of:

  • patient population
  • intervention(s)
  • comparator(s), and
  • health outcomes (PICO)

A JCA is based upon:

  • the scientific aspects of the clinical domains of HTA of the description of the health problem addressed by the health technology and the current use of other health technologies addressing that health problem,
  • the description and technical characterisation of the health technology,
  • the relative clinical effectiveness, and
  • the relative safety of the health technology

Source: Health Technology Regulation (EU) 2021/2282

After 12 January 2025, medicinal products falling under the scope of Article 7(2), point (a) of Regulation (EU) 2021/2282 (the HTA Regulation) will be subject to a Joint Clinical Assessment (JCA).

  • From 12 January 2025 the JCA will concern
    • medicinal products with new active substances for which the therapeutic indication is the treatment of cancer as well as
    • advanced therapy medicinal products.
  • As of 13 January 2028, all medicinal products designated as orphan medicinal
    products
  • As of 13 January 2030, all other medicinal products falling under the scope of
    Article 7 of Regulation 2021/2282 are also subject to JCA.

Which document supports the identification of products subject to Joint Clinical Assessment (JCA) from 2025?

The Member State Coordination Group on Health Technology Assessment published a document on 13 June 2024 entitled “Scientific specifications of medicinal products subject to joint clinical assessments” to support identification of products subject to JCA from 2025.

Which document informs applicants/health technology developers on how to declare in the EMA Letter of Intent whether their application falls under the scope of the Health Technology Assessment Regulation ((EU) 2021/2282 Article 7 and is therefore subject to JCA?

The EMA guidance Joint clinical assessment of medicinal products: Submission of early information by health technology developers of 21 June 2024 informs applicants/health technology developers on how to declare in the EMA Letter of Intent (via the Pre-submission request form) whether their application falls under the scope of the Health Technology Assessment Regulation ((EU) 2021/2282 Article 7) and is therefore subject to JCA.


Once the applicant/health technology developer declares to the EMA that their application falls under the scope of the HTA Regulation, who else are they also required to inform and what information should the notification include?

In case the applicant/health technology developer declares to the EMA that their application falls under the scope of the HTA Regulation, the applicant/health technology developer is also requested to notify the secretariat of the Member State Coordination Group on Health Technology Assessment (HTACG) at the European Commission by sending an e-mail to the following e-mail address: SANTE-HTA-JCA@ec.europa.eu. The e-mail shall contain:

  • A request by the applicant/health technology developer to access the HTA IT Platform to upload the EMA Letter of Intent (i.e. Pre-submission request form).
  • Name, EU Login account user name and e-mail address (linked to the EU Login) of a contact person from the health technology developer for the purposes of the JCA under the HTA Regulation for the particular medicinal product.
  • To create an EU Login account, please refer to this page: Help for external users (europa.eu)
  • No sensitive information shall be included in this e-mail about the product or applicant.

What happens once the secretariat of the HTACG receives the notification from the applicant/health technology?

Following the receipt of the e-mail, the secretariat of the HTACG will send an upload link and instruct the health technology developer on how to upload on the HTA IT Platform, a copy of the Letter of Intent which the health technology developer submitted to the EMA.

  • The secretariat of the HTACG will acknowledge the successful upload of the Letter of Intent by e-mail to the health technology developer.
  • Please note that each upload link provided to the applicant will be specific to one product/letter of intent.
  • Therefore, if health technology developers plan to upload several letters of intent, they must ask for a separate upload link for each letter of intent.

A reminder to Applicants/health technology developers

  • Applicants/health technology developers are reminded to submit, in parallel to the notification procedures published by EMA, any updates on changes to the intended marketing authorisation application submission date and/or
  • to inform of their intention to no longer pursue their application to the secretariat of the HTACG via the HTA IT Platform if the application was identified to fall under Article 7 of Regulation 2021/2282.
  • The applicants/health technology developers are also reminded to contact the secretariat of the HTACG if their planned marketing authorisation submission for a product that was not originally envisaged to be subject to JCA becomes subject to it due to a delay in the submission of the marketing authorisation application to EMA.

A Joint Scientific Consultation (JSC) is a process established under Regulation (EU) 2021/2282 on Health Technology Assessment (HTAR) that enables Health Technology Developers (HTDs) to exchange information on their development plans for a medicinal product or medical device with the Member State Coordination Group on Health Technology Assessment (HTACG).

  • The primary aim of a JSC is to provide guidance to HTDs on the information, data, analyses, and other evidence that are likely to be required from clinical studies for the subsequent Joint Clinical Assessment (JCA) of those health technologies.
  • This guidance is intended to streamline the preparation for JCAs and enhance the quality of clinical studies

Source: Joint Scientifc Consultation for Medicinal Products – European commission

On 3rd February 2025, the European Commission launched the first request submission period for joint scientific consultations (JSCs) under the Health Technology Assessment Regulation (EU) 2021/2282.

  • The JSCs enable health technology developers (HTDs) to exchange information with regulatory authorities on their development plans for a medicinal product or medical device.
  • They also enable HTDs to obtain guidance on the information, data, analyses, and other evidence that are likely to be required from clinical studies for the joint clinical assessment of those products.
  • The JSCs are conducted by the JSC subgroup of the Member State Coordination Group for health technology assessment (HTA CG).

The current request submission period runs from 3 February to 3 March 2025. In their requests, HTDs can apply for the following consultation slots for medicinal products:

Procedure start dateBriefing document by
2–5 June 2025Briefing document by 5 May 2025
7–10 July 2025Briefing document by 2 June 2025
1–4 September 2025Briefing document by 7 July 2025

Source: eNews (European commission), European Commission

On 2 June 2025, the Commission opened the second submission period for joint scientific consultations (JSCs) under the EU Health Technology Assessment Regulation.

  • JSCs enable health technology developers to consult on the planning of their health technology clinical studies and clinical investigations of a health technology, regarding the information and evidence needed for a subsequent Joint Clinical Assessment.
  • The submission period is open from 2 to 30 June 2025 to developers of both medicinal product and medical devices.

Developers can apply for consultation slots during this time as follows:

Procedure start dateBriefing document by
29 September–2 October 2025Briefing document by 1 September 2025
27–30 October 2025Briefing document by 29 September 2025
24–27 November 2025Briefing document by 27 October 2025
12–15 January 2026Briefing document by 1 December 2025

Requests must be uploaded to the HTA IT Platform by 30 June 2025. As access to the platform can take a few days, early registration is recommended.

In addition to the guidance documents for JSCs for medicinal products, the guidance documents for JSCs for medical devices and in-vitro diagnostic medical devices have also been published.

Source: eNews (European Commission), European Commission

1. Health Technology Assessment – European Commission

2. From Theory to Practice: Implementing the EU Health Technology Assessment Regulation – Video recording of Stakeholder event, European Commission 30 January 2024. At this event, the Commission provided an overview of the new EU HTA Regulation. This will be followed by panel discussions, featuring local speakers who will discuss key topics related to the implementation of the regulation.

3. Preparing for the implementation of the EU Health Technology Assessment Regulation -Jackie Mulryne et al, 2 May 2024, biosliceblog.com

EU Health Technology Assessment Regulation 2021/2282 – A pan-European guide to better preparedness

You can download this comprehensive HTA Regulation Guide (which includes information by country), developed by the DLA Piper life sciences regulatory team across the EU, is designed to inform life sciences companies operating in the EU about the implementation of the Regulation in the member states, and provides actionable insights to navigate these changes.9

The guide includes details on the current framework regulating HTA in the EU member states, and what new legislation or other steps have been taken towards implementation of the HTA locally, as well as key challenges and open questions.9

References

1. The EU Regulation on Health Technology Assessment: investing in the healthcare of the future , 22 October 2021- European Commission

2 Questions and Answers: Adoption of Regulation on Health Technology Assessment, 13 December 2021 – European Commission

3. The EU HTA Regulation: a new frontier for access to innovative technologies –  Giuseppe Ragucci (BonelliErede), Vincenzo Salvatore (BonelliErede) 25 August 2022- europeanpharmaceuticalreview.com

4. Regulation on Health Technology Assessment – European Commission

5. Towards a permanent collaboration framework for EMA and Health Technology Assessment -bodies – 15 September 2023 – European Medicines Agency

6. Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU -Eurlex

7. Factsheet on the implementation of the HTA regulation, 5 October 2023 – European Commission.

8. Implementation of the Regulation on health technology assessment – European Commission

9. EU Health Technology Assessment Regulation 2021/2282 -A pan-European guide to better preparedness, Marco de Morpurgo, DLA Piper