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            <title>Recently Published About HMA</title>
            <link>https://www.hma.eu//rss/recently-published-about-hma.html</link>
            <description>New contents from the website www.hma.eu. Category: Recently Published About HMA</description>
            <language>en</language>
            <copyright>Heads of Medicines Agencies</copyright>
            <pubDate>Sun, 12 Apr 2026 10:55:45 +0200</pubDate>
            
                <item>
                    <title><![CDATA[Strategy Papers]]></title>
                    <description><![CDATA[European medicines agencies network strategy to 2025 - Final report
Initially published in 2020, EMANS 2025 was the main strategy guiding the delivery of the operational, regulatory and scientific output of the European Medicines Agency (EMA) and the National Competent Authorities (NCAs) for medicines in the EU. The strategy set out goals and priorities for the years 2021 to 2025 to provide strategic direction to the work of the European Medicines Regulatory Network (EMRN).
The strategy outlined six priority focus areas, with clear strategic goals and objectives for each area. The actions to fulfil the goals and objectives were incorporated by EMA and the HMA into their respective work plans and programming documents.
The current report describes the main achievements of the network in implementing the strategy from January 2021 to the end of 2025. The structure follows the goals and objectives originally defined in the strategy.For each objective, the report has a section ‘Follow-up actions in EMANS 2028’ which describes further related activities the network will carry out as it implements the next strategy (EMANS 2028) from 2026 to 2028.
European medicines agencies network strategy to 2025 - Final report  | pdf


The European medicines agencies network strategy 2028
Joint strategy sets direction of EMA and EU medicines regulatory agencies to 2028Seizing opportunities in a changing medicines landscapeEMA and the Heads of Medicines Agencies (HMA) have published their joint EU medicines agencies’ network strategy to 2028 (EMANS), following its recent adoption by the HMA and the EMA Management Board. 
The strategy, titled ‘Seizing opportunities in a changing medicines landscape’, is a comprehensive update of the five-year strategy which was developed to cover the period 2021 to 2025 (EMANS 2025). The updated document will guide the European medicines regulatory network over the next few years to meet the challenges ahead, including preparing for, and responding to, public health emergencies and threats such as antimicrobial resistance.
The six strategic focus areas of EMANS to 2028
The strategic focus areas of the strategy to 2028 are as follows:
Accessibility – to facilitate pathways for access to medicines through healthcare systems in the EU.Leveraging data, digitalisation and artificial intelligence – to improve decision-making, optimise processes and increase efficiency.Regulatory science, innovation and competitiveness – to create a regulatory and research environment that accelerates the translation of innovation and improves competitiveness of the EU’s healthcare sector.Antimicrobial resistance and other health threats – to prepare the EU for potential threats including antimicrobial resistance.Availability and supply - to strengthen the availability of medicines to protect public and animal health.Sustainability of the network – to ensure that the network has available resources to support its scientific and regulatory decision-making, taking full advantage of technological advances.
The strategy was developed through extensive collaboration with experts and stakeholders across the EU medicines regulatory network. A public consultation took place in late 2024, during which 77 submissions from the public and stakeholders provided valuable feedback which helped shape the strategy. EMA and the HMA, in partnership with the EU Polish presidency, also held a webinar with stakeholders in February 2025 to further refine and finalise the text.
EMA and HMA will now implement the strategy via their respective multi-annual workplans and at national level. The network will monitor its implementation, report back and adjust as needed. 
The final strategy is published with an overview of the comments [LINK] received during the public consultation.
The European medicines agencies network strategy 2028 - Seizing opportunities in a changing medicines landscape | pdf
EMAN Strategy to 2028 - Analysis and summaries of public consultation results report | pdf 

EU Medicines Agencies Network Strategy to 2025
EMA and the Heads of Medicines Agencies (HMA) have published their joint strategy to 2025, following its adoption by the HMA and EMA Management Board.
The strategy details how the European medicines regulatory network can continue to enable the supply of safe and effective medicines that meet patients’ needs in the face of challenges posed by ever-accelerating developments in science, medicine, digital technologies, globalisation as well as emerging health threats, such as the COVID-19 pandemic.
The European medicines agencies network strategy to 2025 outlines six priority areas for the network: 
 the availability and accessibility of medicines;data analytics, digital tools and digital transformation;innovation;antimicrobial resistance and other emerging health threats;supply chain challenges; andthe sustainability of the network and operational excellence.
It identifies strategic goals for each of these areas, which will be translated into concrete actions in the detailed work plans of EMA and the national competent authorities in EU Member States in the coming five years. It also considers some of the recent developments related to the COVID-19 pandemic. Further learnings from the pandemic have been incorporated into the strategy and will be taken into account in subsequent work plans on an ongoing basis.
The joint EMA//HMA strategy was open for public consultation from July to September 2020. The extensive and helpful feedback from the public consultation, which captured input from a full range of stakeholder groups, was carefully analysed and reviewed in order to refine and finalise the strategy. More detail on the comments received and the network’s analysis of these comments is available in a separate document.
The European medicines agencies network strategy was developed in consultation with the European Commission and the key themes are aligned with those covered in the Commission’s Pharmaceutical Strategy that will set the tone of future pharmaceutical policy for human medicines in the EU.
The network will review the strategy after 18 months to consider if the goals and objectives remain appropriate, and to adjust them if necessary, in the light of the changing environment and ongoing engagement with stakeholders.
EU Medicines Agencies Network Strategy to 2025 | pdf


EU Medicines Agencies Network Strategy to 2020
The European Medicines Agency (EMA) Management Board and the Heads of Medicines Agencies (HMA) have adopted a common strategy to 2020 for the European medicines regulatory network.
This is the first time that a single strategy for the whole network has been developed. It outlines common challenges and opportunities and sets out joint key priorities and a high-level roadmap to achieve these over the next five years. The strategy also supports the strategic priorities of the European Commission and the European Union (EU) agenda on human and animal health.
EU Medicines Agencies Network Strategy to 2020 | pdf

Multi Annual Work Plan
After finalisation of the joint HMA/EMA strategy to 2020, the HMA developed a Multi Annual Work Plan (MAWP) to bring the joint overarching strategy into operation on the HMA level with the involvement of all National Competent Authorities. The MAWP has been developed by a HMA taskforce and was debated extensively in break-out sessions during the 2015 HMA plenary meetings in Luxemburg and Dubrovnik. The MAWP has been adopted on 17 February 2016 during the 83rd HMA meeting in Amsterdam.
Eleven topics were agreed as priority areas, namely:
Antimicrobial resistanceAvailability of good quality appropriately authorised medicinesCompetence development programme through the EU Network Training CentreDeveloping an efficient, effective and collaborative approach on inspections to address sustainabilityInnovation and access to new medicinesInternational collaborationOptimisation of the regulatory operationsResponding to public and animal health emergenciesStrengthen surveillanceImplementation of the Telematics strategySupport for better use of medicine
Multi Annual Work Plan (MAWP) | pdf

HMA Strategy Paper (2010)
The European Heads of Medicines Agencies (HMA) group devloped a second HMA strategy document for the period 2011-2015, which was finalised and published at the end of 2010. As part of the strategy developemnt process, and in line with good practice, the HMA consulted with key stakeholder groups on the strategy's content.
HMA Strategy Paper 2010 | pdf]]></description>
                    <link>https://www.hma.eu//about-hma/publications-and-reports/strategy-papers.html#c2360</link>
                    <guid>https://www.hma.eu//about-hma/publications-and-reports/strategy-papers.html#c2360</guid>
                    <pubDate>Mon, 04 Jan 2021 12:22:00 +0100</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[SUBSCRIBE to NEWSLETTER
31/3/2026      HMA newsletter March 2026
26/2/2026      HMA newsletter February 2026
27/1/2026      HMA newsletter January 2026
22/12/2026    HMA newsletter December 2025
3/12/2025      HMA newsletter November 2025
20/10/2025    HMA newsletter October 2025
24/09/2025    HMA newsletter September 2025
15/07/2025    HMA newsletter July 2025
17/06/2025    HMA newsletter June 2025
14/05/2025    HMA newsletter May 2025
16/04/2025    HMA newsletter April 2025
16/04/2025    HMA Launches its Newsletter to provide updates about its coordinated work in the European regulatory network]]></description>
                    <link>https://www.hma.eu//about-hma/newsletter/newsletters.html#c7736</link>
                    <guid>https://www.hma.eu//about-hma/newsletter/newsletters.html#c7736</guid>
                    <pubDate>Thu, 10 Apr 2025 15:28:08 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[SAFE CT]]></title>
                    <description><![CDATA[HALMED Hosted the Final Conference of the EU Project SAFE CT in Zagreb
The SAFE CT Final Conference, organised by the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) on behalf of the SAFE CT consortium, was held in Zagreb on 19 March 2026.
The final conference brought together around 70 representatives of competent national regulatory authorities from the member states of the European Union and the European Economic Area and provided an opportunity to present the project’s key results and exchange experience gained during its implementation.
At the opening of the conference, participants were welcomed by Prof. Siniša Tomić, Head of HALMED.  Keynote speakers for the conference were  Dr. Marianne Lunzer, Chair of the Clinical Trials Coordination Group (CTCG) within the Heads of Medicines Agencies (HMA) and industry were represented by Nikola Lazarevski from PrimeVigilance
During the conference, the activities of all work packages implemented throughout the project were presented, starting with Work Package 5: Capacity Building, followed by Work Package 4: Sustainability, Work Package 3: Evaluation, Work Package 2: Dissemination, and concluded with Work Package 1: Coordination. Particular emphasis was placed on the experience of new assessors employed within the SAFE CT project, as well as on the experience of their mentors. 
The Final Conference provided a valuable opportunity to reflect on the achievements of the SAFE CT project, highlight the strengthened collaboration among European regulatory authorities, and outline key considerations for ensuring the sustainability of harmonised safety assessment in clinical trial assessment across the EU/EEA. The event marked the successful upcoming conclusion of the project.


Safety Assessment Cooperation and Facilitated Conduct of Clinical Trials
Safety Assessment Cooperation and Facilitated Conduct of Clinical Trials (SAFE CT) | pdf
The new Clinical Trial Regulation EU No. 536/2014 and Implementing regulation (IR) which came into force on 31 Jan 2022 introduced the concept of safety cooperation and work-sharing among Member States (MSs)
Joint Action (JA) 12 of the EU4Health Safety Assessment Cooperation and Facilitated Conduct of Clinical Trials or SAFE CT supports these new concepts through provision of additional resources and expertise necessary to implement the new regulation.
The goal of this JA is to establish and maintain cooperation in safety data assessment in clinical trials via building capacities and performing training activities in the participating MSs. The experience gained during the JA will be used to update and improve the procedures on cooperation and training in safety surveillance in clinical trials.
The project is currently in grant management phase and will run for 36 months (with a retrospective start date from 01/05/2022 to 30/04/2025). 

First Annual SAFE CT Safety Assessor Event
The first Annual SAFE-CT Safety Assessor Event was held in Amsterdam at the offices of the EMA on 30-31 January. The event included plenary sessions from external experts in medicines regulation and pharmacovigilance as well as in paediatric oncology and in paediatric clinical trials in addition to workshops on Annual Safety Report (ASR) and Suspected Unexpected Serious Adverse Reaction Report (SUSAR) assessment. The event was attended by 52 participants from 26 countries and it was the first of 3 such events planned for the lifecycle of the Joint Action, the focus of which is the exchange of experience and knowledge and the fostering of cooperation in safety assessment across the network. Further information on the event is highlighted in the 13th edition of the 'Clinical Trials highlights' newsletter. 

Face-to-Face Safety Assessor Round Table
In May 2023, the first face-to-face safety roundtable meeting was held in Bonn, Germany. This event, which was organised under Work Package 4 “Sustainability”, brought together 69 participants from 23 Member States. The event was part of the regular suite of virtual meetings run under WP4, whose aim is to build and maintain an expert community network to improve existing procedures, exchange experience and discuss scientific issues relating to pharmacovigilance in clinical trials.


Second Annual SAFE CT Safety Assessor Event
On 15-16 January 2024 EMA hosted the second annual safety assessors event within EU4Health Joint Action Safety Assessment Cooperation and Facilitated Conduct of Clinicall Trials (SAFE CT). 54 safety assessors from 24 different member states participated in the training on safety surveillance of clinical trials. The training included lectures from industry and regulatory authorities on monitoring procedures as well as dedicated workshops rellated to decision making in safety surveillance. Participants also had an opportunity to network within the regulatory community.
A final Safety event is planned for January 2025.


Second Face-to-Face Safety Assessor Round Table
The 2nd ‘SAFE CT - Face to Face Roundtable Meeting’ took place from June 5 to 6, 2024 at the BfArM in Bonn.
The network and training event included plenary lectures on signal management and PSUR assessment in Pharmacovigilance (PV) of marketed products by regulatory authorities as well as insight into clinical research in neurodegenerative disease by a dedicated Research Organisation. In addition, a hands-on workshop focussed on signal management in clinical trials.
Approximately 53 participants from 21 Member States shared experiences in assessment and the coordinated processes to further harmonise and optimise these procedures in safety surveillance (PV) in clinical trials.
The event was another key building block in ensuring that the EU/EEA remains an important location for conducting safe clinical trials in the future. 

Joint Annual SAFE-CT Safety Assessor Event and Face-2-Face Safety Assessor Round Table Event
A joint annual SAFE-CT safety assessor event and Face-2-Face safety assessor round table was held in Amsterdam at the offices of the EMA on 31st March to 2nd April 2025.
The first day of the meeting was dedicated to social activities, including a guided tour at the Rijksmuseum and a dinner, which helped participants network before the meeting.
The second day began with discussions on FIH trials, where representatives from a CRO and the Ethics Commission from Leiden explained their processes. This was followed by breakout sessions, allowing participants to gain hands-on experience in assessing SUSARs and share their practices.
In the afternoon, Elena Prokofyeva (FAMHP, Belgium) introduced the use of AI in clinical drug development, focusing on safety and PV. She also shared the Belgian Federal Medicines Agency's experience with AI integration into their workflow. The session concluded with a survey on AI knowledge and use, followed by a fruitful discussion on current experiences.
The meeting was enriched by three excellent presentations: two from pharmaceutical companies (Minhaj Obeidullah, Novartis and Claudia Lehmann, Boehringer Ingelheim) and one from the EMA (Joaquim Berenguer Jornet). They shared their experiences on integrating AI into their workflows, expressing both concerns and enthusiasm about AI's potential impact. The EMA's journey in implementing AI was particularly insightful.
Finally, the presenters held a panel discussion on AI regulation, future perspectives, and considerations for the future of AI. 

Safe-CT Project Extension
The Safety Assessment Cooperation and Facilitated Conduct of Clinical Trials (SAFE CT) Steering Committee  are delighted to announce the extension of the project for 1 year, from April 2025 to April 2026.  The amendment to extend the project duration was approved by the European Commission on (24th April 2025). The project will continue to support the objectives of Joint Action (JA)12 in fostering cooperation and harmonisation of safety assessment for clinical trials within the European Union
 The Clinical Trial Regulation and Implementing regulation which came into force on 31 January 2022 introduced the concept of safety cooperation and work-sharing among Member States.
Joint Action (JA) 12 of the EU4Health Safety Assessment Cooperation and Facilitated Conduct of Clinical Trials (SAFE CT) supports these new concepts through provision of additional resources and expertise necessary to implement the new regulation.
The goal of this JA is to establish and maintain cooperation in safety data assessment in clinical trials via building capacities and performing training activities in the participating Member States. The experience gained during the JA will be used to update and improve the procedures on cooperation and training in safety surveillance in clinical trials.]]></description>
                    <link>https://www.hma.eu//about-hma/working-groups/clinical-trials-coordination-group/clinical-trials-coordination-group.html#c7087</link>
                    <guid>https://www.hma.eu//about-hma/working-groups/clinical-trials-coordination-group/clinical-trials-coordination-group.html#c7087</guid>
                    <pubDate>Tue, 20 Jun 2023 14:17:00 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[CTCG News and Events]]></title>
                    <description><![CDATA[Article 11 workaround – MSCs intended to receive Part I only initial submission 
Sponsors are encouraged to include all MSCs where the clinical trial is planned to be conducted in the initial application to promote alignment of the Part I dossier (see Article 11 of the Clinical Trials Regulation on Part I only initial submission). 
However, in current CTIS sponsors cannot proceed with trial applications (substantial modifications, additional MSCs) if MSCs remain as Part I only.
A new Article 11 workaround (see the guidance published on the website on March 27 2026) applies from April 27 2026. It allows sponsors to include MSCs intended to receive Part I only by submitting Part II placeholders. The procedure also involves Part I only MSCs in reviews of subsequent SM Part I applications.
The trial is neither allowed to start nor recruit participants in MSCs where only placeholder data/documents Part II were submitted before actual Part II data/documents have been submitted and authorised.
For more background, see CTAG (Clinical Trials Coordination and Advisory Group) minutes to be published by the European Commission Mar 27 2026 from the Nov 27-28 2025 meeting at the Register of Commission expert groups and other similar entities, where CTAG is listed as group X03839
CTCG will organise a webinar on 15 April 2026 2pm to 3:30 pm CET. Recording of this event will be made available. No registration is required. Participants can join the meeting directly by accessing the teams link included in the agenda. 
During the webinar it will be explained how to apply this new approach, how to monitor these trials and where to find the supporting documents.
This webinar will also provide insights into the new approach where to upload translated versions of patient facing documents into CTIS.
The target audience of the webinar is all external stakeholders involved in clinical trial application submissions.
Participants will have the opportunity to ask questions during the webinar. A slido will be opened after the webinar to allow participants to raise any further questions
Meeting schedule for 2026
DateDate of the weekLocation09-10 February 2026Monday & Tuesday EMA09-10 March 2026Monday & Tuesday Virtual 13-14 April 2026Monday & TuesdayEMA19 May 2026TuesdayVirtual03-04 June 2026Tuesday & Wednesday Cyprus 08-09 July 2026 Wednesday & Thursday Virtual 09-10 September Wednesday & Thursday EMA08-09 October 2026Thursday & Friday Virtual 19-20 November 2026Thursday & FridayIreland 09-10 December 2026Wednesday & Thursday Virtual

]]></description>
                    <link>https://www.hma.eu//about-hma/working-groups/clinical-trials-coordination-group/clinical-trials-coordination-group.html#c7039</link>
                    <guid>https://www.hma.eu//about-hma/working-groups/clinical-trials-coordination-group/clinical-trials-coordination-group.html#c7039</guid>
                    <pubDate>Mon, 22 Jul 2024 15:26:00 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[31 March 2026
April Application Update and Next Steps 
The FAST-EU project continues to gain momentum, with strong engagement from Sponsors and National Competent Authorities. During the latest submission window, the project received 23 applications, reflecting the growing interest in contributing to FAST-EU’s development and coordinated processes.
In response to this high level of interest, and due to the substantial number of applications received, participating Member States agreed to accept four applications for this cycle, once again exceeding what had initially been planned. This collaborative decision underlines the commitment of the National Competent Authorities involved to keep supporting the project’s fast pace and broad participation.
We are pleased to share that the role of Reporting Member State for these evaluations will be taken up by Belgium, Norway, Spain, and the Czech Republic. 
Looking ahead, preparations are already underway for the next FAST-EU submission window, scheduled for 22–23 April 2026. Applicants are once again invited to inform us on the preferred weeks for CTIS submission.
The FAST-EU project continues to thrive thanks to the dedication of its applicants and the good collaboration between Ethics Committees and National Competent Authorities. Together, we are advancing a more coordinated and efficient approach to collaboration across European Union and European Economic Area.

17 March 2026
FAST-EU Project - Updates on the process, applications and RMS selected
FAST‑EU continues to generate strong interest from sponsors across the EU clinical trials landscape. To date, 26 applications have been submitted, with 7 procedures accepted, exceeding the initial expectations for the pilot. 
Selection remains challenging due to demand surpassing available capacity. Member States discussed their ability to take on more than two FAST-EU procedures per month, noting that capacity depends on factors such as the timing of CTIS submissions clinical trial unit resources and  ethics committee workload . The FAST-EU Selection Committee agreed to continue consulting closely with highly affected Member States whenever more than two procedures appear likely in a single month. 
Recent refinements to the FAST-EU process were also presented at the last CTCG meeting on 9-10 March 2026, including the introduction of:
fixed windows for expressions of interest,advance selection of preferred CTIS submission weeks, andthe adoption of a single fixed CTIS submission date (instead of a date range), which is essential for ethics committee planning and avoids uncertainties at Member State level. 
Furthermore, combined clinical trial and IVD performance study /Medical Device (MD) clinical investigation applications will no longer be taken into FASTEU at this stage, given that several Member States cannot assess the IVD/MD component within the required timelines. This clarification will be reflected in the sponsor guidance to ensure consistent expectations.
Work is also ongoing to further refine the KPIs for the pilot, with updates to be shared after input from the FAST-EU Steering Group. 
RMS Selected in the Most Recent Slot
The following Reference Member States (RMS) have been selected for the FASTEU slot in March:
Germany  Poland  Finland  Sweden  
These selections reflect efforts to distribute workload appropriately while maintaining feasibility across participating Member States. To support an equitable distribution of workload and to broaden Member State participation in the pilot, sponsors are encouraged to select RMS that have not yet been chosen in previous FAST-EU rounds whenever feasible.


12 February 2026
FAST-EU Project – Update on Applications and Upcoming Submission Windows
The CTCG is pleased to share a progress update on the FASTEU project. We are delighted to announce that more than 10 applications have already been received, reflecting strong interest and engagement from Sponsors across Europe. We sincerely thank all Applicants for their proactive participation and trust in the FAST-EU initiative.
Allocation of February Slots and Selection Criteria
All available slots for February have now been allocated. Owing to the high number of applications received in this first month, the FAST-EU Selection Committee and the Member States agreed to accept more than two applications for February. To ensure a fair and impactful start to the project, strict selection criteria were applied, considering:

The indication proposedThe level of unmet medical needThe characteristics of the study population
For this first round, the RMS selected are The Netherlands, Denmark, and Italy.
Consideration of RMS and MSC Distribution
In addition to the established criteria outlined in the Guidance for Applicants, the FAST-EU Selection Committee will also consider a fair distribution of RMS and MSC roles among the participating MSs In this way, all MSs get the opportunity to serve as RMS in the pilot procedures and support national knowledge gain related to accelerated timelines.  
Sponsors are therefore encouraged to consider selecting different RMS when preparing future applications, as doing so may increase the likelihood of being selected. Furthermore, Sponsors who have not yet been selected in previous rounds will be prioritised in upcoming reviews when their applications meet the other prioritisation criteria (like therapeutic area, unmet medical need, workload distribution, etc.).
Upcoming Application Windows
To manage the growing number of applications, two dedicated application windows have been scheduled:

23–24 February (for applications to be submitted in CTIS in March)23–24 March (for applications to be submitted in CTIS in April)
Applicants are requested to apply according to the indicated slot (March or April) and specify whether the CTIS submission will be possible in the first or second half of the respective month. 

Expression of Interest Template

6 February 2026
FAST-EU Expression of Interest - No more slot available in February
Due to the huge interest in the pilot initiative, all slots for February have already been allocated. You are welcome to apply again next month, the slot for Expression of Interests will be communicated in due course. Please note that this does not guarantee selection for the FAST-EU project, as each submission is assessed by the FAST-EU Selection Committee in view of all applications received. 

2 February 2026
FAST-EU Expression of Interest Status Update
We are pleased to announce that we have received a high number of applications for the current FAST-EU Expressions of Interest cycle, reflecting the strong interest in this initiative.
As per our process, two cases will be selected based on their medical relevance, priority and availabilities of members States resources.
We will keep you informed about the outcome of this selection process in due course.
For any urgent questions, please write an email to FAST-EU@hma.eu.

21 January 2026
FAST-EU Facilitating and Accelerating Strategic Clinical Trials in the EU/EEA
FAST-EU is an initiative by HMA, CTCG and MedEthics EU that enables an accelerated assessment of multinational clinical trials in the European Union. Operating within the EU Clinical Trials Regulation and CTIS, FAST-EU offers sponsors a predictable and efficient pathway for initial clinical trial applications.
The core feature of FAST-EU is a maximum overall timeline of 10 weeks (70 calendar days) from CTIS submission to final conclusion, including sponsor response times. This is achieved through parallel validation and assessment workflows and a strengthened role of the RMS, while maintaining scientific, safety and ethical standards. Ethics Committee opinions are fully integrated across all participating Member States.
Beyond accelerating individual applications, FAST-EU also functions as a structured learning and evidence-generation exercise. The pilot is designed to provide practical insights into the feasibility and challenges of the accelerated assessment model, thereby supporting the future implementation of the EU Biotech Act.
FAST-EU is a voluntary pilot with a planned duration of a year and a limited number of applications per month, so participation cannot be guaranteed.
The following Member States are participating in FAST-EU:
AT, BE, BG, CY, CZ, DE, DK, EE, ES, FI, FR, GR, HR, HU, IE, IT, LV, NL, NO, PL, PT, RO, SE, SI, SK
Detailed procedural information is provided in the FAST-EU Sponsor Guide.
To enter a trial that is ready for submission in CTIS into FAST-EU starting from 30 January 2026, sponsors should express their interest by sending the Expression of Interest Form which can be found as Annex to the FAST-EU Sponsor Guide via e-mail to FAST-EU@hma.eu. 
A response can be expected within 5 business days.]]></description>
                    <link>https://www.hma.eu//about-hma/working-groups/clinical-trials-coordination-group/clinical-trials-coordination-group.html#c7860</link>
                    <guid>https://www.hma.eu//about-hma/working-groups/clinical-trials-coordination-group/clinical-trials-coordination-group.html#c7860</guid>
                    <pubDate>Wed, 21 Jan 2026 10:36:12 +0100</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Secretariat vacancy]]></title>
                    <description><![CDATA[Call for Expression of Interest for SVG Secretariat
Identified tasks of SVG Secretariat:  
Organizing and hosting any Team meeting F2f, online in EU and transatlanticSupport in software testing, when neededMaintain SVG-SRS mailbox, allocate emails to the relevant SVG groupLiaise with NCA’s on EU-SRS mattersMaintain the HMA SVG Working group websiteStakeholder contact 
SVG Secretariat – competency profile: 
Excellent organizational skillsOrganizational sensitivityExcellent communication skills, writing and verbal (English)Presentation skillsHigher education (e.g. bachelor, university or similar degree)Ms Office skills (Excel, PowerPoint, SharePoint)
Skills to be learned on-the-job, if not yet available: 
Basic understanding of ISO-IDMP, or affinity with standardization topicsSPOR, including SMS in relation with EU-SRSEU-SRS in relation to GSRSWorking process in the validation of substances in the SRS instancesEU-SRS: use of CV’s, User rights, database validation rules]]></description>
                    <link>https://www.hma.eu//about-hma/working-groups/hma/hma-substances-validation-group.html#c7857</link>
                    <guid>https://www.hma.eu//about-hma/working-groups/hma/hma-substances-validation-group.html#c7857</guid>
                    <pubDate>Wed, 17 Dec 2025 14:29:18 +0100</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[CTCG Key documents list]]></title>
                    <description><![CDATA[TEMPLATES 
COVER LETTERS and RFI RESPONSE
CTCG provides the following templates, to be used in different situations:
Initial Applications
Initial application cover letter | docx - Version 6, March 2026Part II placeholder document Article 11 workaround | pdf - Version 1.0, March 2026 (see Article 11 guidance for sponsor below)
Substantial Modification (SM)
Cover letter | docx - Version 4, March 2026Modification description | docx - Version 3, March 2026
Request of Further Information
RFI Response List of Changes to the Application | docx - Version 2, June 2025 
CTIS Guidance
Best practice guide naming of documents in CTIS | pdf - Version 3, March 2026
Sponsor guidance on Article 11 workaround
Guidance for sponsor on Article 11 workaround | pdf - Version 1, March 2026MSC intended to receive part I only initial submission - procedure applies from April 27 2026
Transitional Trials
CTCG Best Practice Guide for sponsors who have missed the transition timeline | pdf - Version 1, January 2025CTCG Best Practice Guide for sponsors of multinational clinical trials with different Part I document versions approved in different Member States under the Directive 2001/20/EC that will transition to the Regulation (EU) No. 536/2014 | pdf - Version 5, June 2024Annex I - Cover letter template | docx - Version 5, June 2024Annex II - Fees for transitional trials in MSs | pdf - Version 1, June 2024
First SM: document requirements after transition
CTCG Best Practice Guide to sponsors updating the application dossier Part I after CTR transition | pdf  - Version 1, June 2024Annex I Cover letter template First SM after Transition | docx - Version 3, November 2025Annex II Modification Description template First SM after transition  | docx - Version 2, June 2024Annex III First SM Part II after transition | pdf - Version 1, April 2024
GUIDANCE
Frequently asked questions related to Clinical trials submitted under the Regulation EU 536/2014
FAQ document | pdf - Version 1, May 2025
Guide for Change of Trial Sponsor
Guide for Change of Trial Sponsor | pdf - Version 1, February 2025
CTCG Best practice Seasonal Vaccines for sponsor
CTCG Best practice Seasonal Vaccines for Sponsor | pdf - Version 1, January 2025
Fees for clinical trials submitted under CTR 
Fees for clinical trials submitted under CTR | pdf - Version 1.1, July 2025 
Complex Clinical Trials
Complex clinical trials (CCTs) – Questions and answers - Version 1, May 2023Question and Answers document on CCT and CTIS - Version 2, October 2025Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials | pdf - Version 1, February 2019
Clinical Trial Safety
Q&A on Safety Addendum - Version 3, December 2025Simplified template of Annual Safety Report - Version 2, October 2025. 
GLP Principles
In order to avoid rejection of clinical trial applications, sponsors should ensure that all pivotal non-clinical safety studies follow the Good Laboratory Practice Recommendation paper provided below. Importantly, all pivotal non-clinical safety studies performed outside OECD or fully MAD adherent countries should fulfil the requirement of a successful GLP inspection (i.e. a full test facility inspection or inspection of the study submitted as part of the dossier) by an EU GLP compliance monitoring authority, within three years before or after the final study report date. This information should be provided in the application dossier, filling in the template table provided below. For additional information about OECD or fully MAD countries, please contact the national contact point of the MS.        
Recommendation paper | pdfTemplate table to provide the requested information | docx
Other Guidance and Q&A Documents
CT-Cure Best Practice Guide and Annex | pdf - Version 1.2, December 2024CTR/IVDR (In Vitro Diagnostic Medical) – Questions and answersAvailable here and hereRecommendations related to contraception and pregnancy testing in clinical trials, version 1.2 | pdf - Version 1.2, March 2024CTCG recommendation to sponsors on managing the impact of the war in Ukraine on clinical trials | pdf - Version 1.2, July 2022


]]></description>
                    <link>https://www.hma.eu//about-hma/working-groups/clinical-trials-coordination-group/clinical-trials-coordination-group.html#c7040</link>
                    <guid>https://www.hma.eu//about-hma/working-groups/clinical-trials-coordination-group/clinical-trials-coordination-group.html#c7040</guid>
                    <pubDate>Fri, 22 Sep 2023 14:13:00 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[CTCG Members and Alternates]]></title>
                    <description><![CDATA[CTCG Members and Alternates are nominated by each EU/EEA National Competent Authorities (NCA) and represent the NCA.The Chair and the Vice-Chair of the CTCG are elected amongst the members for a period of three years. Currently CTCG is chaired by Marianne Lunzer, PhD (AGES MEA, Austria) and vice-chaired by Monique Al, PhD (CCMO, Netherlands)The secretariat is supported by the EMA and an expert from an NCA. The secretariat acts as the contact point for the group.The EMA and the Commission attend the meetings as observers.Representatives from other interested parties and national experts may be consulted and invited to attend the CTCG meetings on an ad hoc basis.
List of CTCG Members and Alternates

Member StateRoleMember NameAT - AustriaChair/MemberMarianne LunzerAT - AustriaAlternateJudith SecklehnerBE - BelgiumMember Anne Lenaers BE - BelgiumAlternate Nele SteensBG - BulgariaMember Ivelina GushlekovaBG - BulgariaAlternate Ivan TodorovCY - CyprusMemberEleni GeorgiadouCY - CyprusAlternateTheognosia PatsaledouCZ - Czech RepublicMember Eva Hrušková Reinová CZ - Czech RepublicAlternateJan NemecekDE - Germany (BfArM)MemberClaudia Riedel DE - Germany (BfArM)AlternateSarah Heil DE - Germany (PEI)MemberSusanne LerchDE - Germany (PEI)AlternateAndreas BonertzDK - DenmarkMemberLene Grejs PetersenDK - DenmarkAlternatePernille SterlingEE - EstoniaMemberKeiu HeinlaEE - EstoniaAlternateIngrid KiiskES - SpainMemberJuan Estévez Álamo ES - SpainAlternateLaura Lavin de JuanFI - FinlandMemberMarita Kailajärvi FI - FinlandAlternatePirjo InkiFR - FranceMemberCorinne KigerGR - GreeceMemberLeonidas KlironomosHR - Croatia (HALMED)MemberMaja PuklekHR - Croatia (HALMED)Alternate Ivana Kosier MihalicHR - Croatia (Miz)MemberIvana Matelic HR - Croatia (Miz)  Alternate Nikolina JozancHU - HungaryMemberÁgnes Zita Hajdú HU - HungaryAlternateCecilia Kurdi IE - IrelandMemberClaire Temple IE - Ireland   Alternate  Tracy Keane IS - IcelandMemberAgnes Engilráð Scheving IS - IcelandAlternateUnnur IngólfsdóttirIT - ItalyMemberSandra PetragliaIT - ItalyAlternateDiego Alejandro DriLI - LiechtensteinMemberVlasta ZavadovaLT - LithuaniaMemberArūnas Vaitkevičius LT - LithuaniaAlternateEglė Daniulevičiūtė LU - LuxembourgMemberEdwige ChokotéLU - LuxembourgAlternateDounia BouzidLV - LatviaMemberJana MiglinieceLV - LatviaAlternateVita Berzina MT - MaltaMemberJohn Joseph BorgMT - MaltaAlternateBenjamin MicallefNL - NetherlandsVice-Chair/MemberMonique AlNL - NetherlandsAlternatePaula VossebeldNO - NorwayMemberIngvild Aaløkken NO - NorwayAlternateIngvild Løberg Tangen PL - PolandMemberEwa Ołdak PL - PolandAlternateAgnieszka DzierwaPT - PortugalMemberJoel PassarinhoPT - PortugalAlternateSusana MarquesRO - RomaniaMemberMirela Vîță RO - RomaniaAlternateSilviu Istrate SE - SwedenMemberGunilla Andrew-Nielsen SE - SwedenAlternateAnn Marie Janson LangSI - SloveniaMemberMaja SkofSI - SloveniaAlternateJurij ŽelSK - SlovakiaMemberJana Grobarčík BallekováSK - SlovakiaAlternateLenka Igazová]]></description>
                    <link>https://www.hma.eu//about-hma/working-groups/clinical-trials-coordination-group/clinical-trials-coordination-group.html#c7043</link>
                    <guid>https://www.hma.eu//about-hma/working-groups/clinical-trials-coordination-group/clinical-trials-coordination-group.html#c7043</guid>
                    <pubDate>Thu, 04 Aug 2022 11:13:00 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[HMA Substances Validation Group Members and Representatives]]></title>
                    <description><![CDATA[Substance experts from AT, CZ, DE-PEI, DE-BfArM, DK, ES, FI, FR-ANSES, FR-ASNM, NL, and NO are part of different groupsRepresentatives from other agencies new and previous participants,  are welcome to join in the groups.The group includes guest membership of WHO-UMC (no access to EU-SRS).Chair: Marcel Hoefnagel, CBG-MEB, NLVice-chair: Bjørg Overby, NoMA, NOMentor: Trygve Ottersen, NoMA, NOSecretary: Vacant postionMeeting cycle: one two-days face-to-face meeting, one two-half day online per year. Regular teleconference meetings, including bi-weekly status meetings technical meetings, and SVG1, SVG2 and SVG3 group meetings.]]></description>
                    <link>https://www.hma.eu//about-hma/working-groups/hma/hma-substances-validation-group.html#c7171</link>
                    <guid>https://www.hma.eu//about-hma/working-groups/hma/hma-substances-validation-group.html#c7171</guid>
                    <pubDate>Mon, 14 Sep 2020 12:56:00 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Collaboration and training]]></title>
                    <description><![CDATA[1. EU-Innovation Network guidance on available scientific and regulatory support tools at national and European level for human medicinal products/technologies/methodologies
This guidance provides an overview of the regulatory support tools available at national and EU level to help developers navigate the medicines development process and identify the most appropriate regulatory interactions. 
Developers are encouraged to consult national and EMA resources for detailed information. 
EU-Innovation Network guidance on available scientific and regulatory support tools at national and European level for human medicinal products/technologies/methodologies
2. Competent authorities in externally funded projects
As part of its mandate, the EU-IN promotes the involvement and collaboration of competent authorities in relevant externally-funded projects. To facilitate this, the EU-IN has developed guidance for researchers and project teams outlining the circumstances under which competent authorities may engage in such projects related to medicinal products. This guidance also specifies the information that should be submitted when seeking a competent authority’s involvement. Any existing position / guidance established by individual competent authorities on this matter should be considered. 
Involvement of competent authorities in externally funded projects
3. Strengthening training of academia in regulatory science (STARS)
STARS was an EU-funded project that run between 2019 to 2022. It assessed the level of knowledge of academic drug researchers on regulatory sciences and the training offered in this area. The STARS Common Strategy summarises the achievements of the project and opportunities to strengthen regulatory science and knowledge.
For more information:  
STARSSTARS overview - leaflet]]></description>
                    <link>https://www.hma.eu//about-hma/working-groups/eu-innovation-network-eu-in/eu-innovation-network-eu-in.html#c7874</link>
                    <guid>https://www.hma.eu//about-hma/working-groups/eu-innovation-network-eu-in/eu-innovation-network-eu-in.html#c7874</guid>
                    <pubDate>Tue, 10 Mar 2026 16:39:06 +0100</pubDate>
                </item>
            
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