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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>Wed, 08 Apr 2026 10:54:15 +0200</pubDate>
            
                <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>
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                <item>
                    <title><![CDATA[Simultaneous National Scientific Advice (SNSA)]]></title>
                    <description><![CDATA[Since February 2020, the EU Innovation Network (EU-IN) has been running a pilot project for simultaneous national scientific advice (SNSA) from national competent authorities (NCAs). SNSA specifically targets scenarios where applicants may wish to seek national scientific advice relating to medicinal products from more than one national competent authority at the same time. 
Examples of scenarios where SNSA could be used include:
Preparation for planned clinical trials to be performed in more than one member state (MS).Planned marketing authorisation applications using the decentralised or mutual recognition procedures.
Following a positive evaluation of the results of the SNSA pilot project at the 119th HMA meeting in January 2025, the HMA has supported the continuation of the SNSA concept.
Over the coming months, the SNSA Working Group of the EU-IN will continue to work on an optimised SNSA procedure taking into account the learnings from the pilot. 
In the meantime, applicants can continue submitting new SNSA requests via snsa@fagg-afmps.be according to the currently available SNSA scope, procedure and timelines until further notice. Further details on the optimised SNSA procedure including associated guidance will be published later in 2025.
How to apply for SNSA
Guidance on how to prepare and submit a formal SNSA request and relevant templates are listed below: 
Guidance to applicantsGuidance on SNSA briefing book format and contentList of participating NCAs and contact information (updated April 2025)Procedural Flow chartApplication formFeedback QuestionnaireMeeting Minutes TemplateAdvice Report Template
For any further information, please contact snsa@fagg-afmps.be.Additional documents 
Simultaneous National Scientific Advice (SNSA) - Continuation and further development during 2025National Scientific Advice ContactsNational Innovation Offices Contacts
Additional information
Key features of the current SNSA procedure include: 
An increased number of NCAs willing to participate in SNSA procedures.A common application form, briefing book template and a single-entry point (email to snsa@fagg-afmps.be) to reduce the administrative burden for applicants.The coordination group (PEI, FAMHP or AEMPS) will liaise with the leading MS who will act as the main contact point for the applicant during the procedure.A predictable timetable to be agreed prior to the start of each procedure.Each SNSA will involve two participating NCAs with the possibility of a third NCA joining as an observer. In special cases, when sufficiently justified by the Applicant, participation of a CTCG representative and/or an Ethic Committee representative in an SNSA request can be considered.In justified cases, e.g. where the request relates to a clinical trial to be performed in more than 2 MSs, the involvement of additional MSs in a single SNSA procedure will be considered subject to the agreement of the NCAs.
The following principles continue to apply: 
All types of applicants can apply for an SNSA pilot. Pre-submission guidance can be requested via the single-entry point for academia and SMEs to assist them in preparing their scientific advice request.Participation of an NCA in any individual SNSA procedure is on a voluntary opt-in basis.The scope of SNSA includes regulatory or scientific questions related to quality, safety and efficacy of medicinal products. Questions can relate to products under development as well as authorised products.The advice given will be limited to the scope of the questions raised by the applicant in the briefing document.SNSA is an opportunity for the applicants to discuss their queries with each of the NCAs involved in the procedure in a joint meeting with the possibility for the NCAs to raise questions related to clinical trials with the CTCG if considered appropriate.The outcome of each SNSA procedure is clearly documented and reflects the position of each of the involved NCAs.The fees for SNSA are based on the national scientific advice fees in each of the participating NCAs and should be paid directly to each participating NCA in the normal manner. There is no fee relating to the involvement of an NCA as an observer.Queries related to HTA and reimbursement are currently excluded
Practical information on how to submit an SNSA request is also available on the websites of the NCAs participating in the SNSA pilots (cfr. List of participating NCA’s and contact information) and on the  EMA website.]]></description>
                    <link>https://www.hma.eu//about-hma/working-groups/eu-innovation-network-eu-in/eu-innovation-network-eu-in.html#c6787</link>
                    <guid>https://www.hma.eu//about-hma/working-groups/eu-innovation-network-eu-in/eu-innovation-network-eu-in.html#c6787</guid>
                    <pubDate>Thu, 08 Dec 2022 14:20:00 +0100</pubDate>
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                <item>
                    <title><![CDATA[Repurposing of authorised medicines]]></title>
                    <description><![CDATA[EMA and HMA launched in 2021 a pilot project to support the repurposing of medicines.
The aim of this project was to help non-profit organisations and academia gather or generate sufficient evidence on the use of an established medicine in a new indication, with the view to have this new use formally authorised by a regulatory authority.
This is a way of making new treatment options available to patients.
For more information:
Repurposing of authorised medicines: pilot to support not-for-profit organisations and academia]]></description>
                    <link>https://www.hma.eu//about-hma/working-groups/eu-innovation-network-eu-in/eu-innovation-network-eu-in.html#c5496</link>
                    <guid>https://www.hma.eu//about-hma/working-groups/eu-innovation-network-eu-in/eu-innovation-network-eu-in.html#c5496</guid>
                    <pubDate>Thu, 21 May 2020 10:53:00 +0200</pubDate>
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