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            <title>Recently Published All categories</title>
            <link>https://www.hma.eu//rss/recently-published-all-categories.html</link>
            <description>New contents from the website www.hma.eu. Category: Recently Published All categories</description>
            <language>en</language>
            <copyright>Heads of Medicines Agencies</copyright>
            <pubDate>Wed, 23 Sep 2026 10:28:50 +0200</pubDate>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[Added in September 2026
22 September
UPDATE - Guidance published by Member States on the implementation of the Falsified Medicines DirectiveNEW - 21-22 July CMDh Minutes
16 September
CORRECTION - 24-25 February CMDh minutes
14 September
NEW - 15-17 September CMDh Agenda
Added in August 2026
04 August
UPDATE - Guidance published by Member States on the implementation of the Falsified Medicines Directive
Added in July 2026
29 July
NEW - Report from the meeting held on 21-22 July 2026UPDATE - Template of letter of intent for the submission of a worksharing procedureUPDATE - EMA/CMDh Explanatory notes on Variation Application Form - Human medicinal products onlyUPDATE - Chapter 7 - CMDh BPG on Variation WorksharingUPDATE - Type II variation Preliminary-Final Variation Assessment ReportNEW - 2026 (Jan-Jun) - Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures
28 July
NEW - 23-25 June CMDh MinutesNEW - Minutes of the 25 June 2026 meeting with Interested Parties
23 July
UPDATE - Contact Points
20 July
NEW - 21-22 July CMDh agenda
03 July
NEW - Summary ARs for doxazosin mesylate/finasterideUPDATE - DCP D70 Overview AR template (incl. instructions) UPDATE - DCP D70 Overview AR template (empty) UPDATE - Instructions for RMS when preparing the PAR based on the FAR UPDATE - PAR template (empty) when prepared based on FARUPDATE - Post-Brexit Q&AUPDATE - Q&A on QP DeclarationUPDATE - Q&A on variationsUPDATE - BPG for the allocation of the MRP variation number for Type I notifications, Type II variations, grouping and worksharing (Chapter 1)UPDATE - BPG for the processing of Type IA minor variations (notifications) in MRP (Chapter 3)UPDATE - BPG for the processing of grouped applications in MRP (Chapter 6)UPDATE - BPG on Variation Worksharing (Chapter 7)UPDATE - Cover letter for variation applications in MRPUPDATE - BPG on the use of eCTD in the MRP/DCPUPDATE - Requirements on submissions for Variations and Renewals within MRP and National Procedures
01 July
NEW - Report from the meeting held on 23-25 June 2026
Added in June 2026
30 June
NEW - 19-20 May CMDh MinutesNEW - Presentations from the 25 June 2026 meeting with Interested Parties
25 June
NEW - Agenda of the CMDh meeting with Interested Parties
22 June
NEW - 23-25 June CMDh agenda
Added in May 2026
27 May
NEW - 21-22 April CMDh MinutesNEW - Art. 46 PAR Rapibloc, Landiolol Hydrochloride Orpha-Devel (landiolol hydrochloride)NEW - Art. 46 PAR Efluelda Tetra (quadrivalent influenza vaccine (split virion, inactivated), 60 micrograms HA/strain)NEW - Art. 46 PAR Vaccin rabique Pasteur, Verorab (rabies virus inactivated (Wistar rabies PM/W138 1503-3M strain))UPDATE - Non Clinical / Clinical AR for Generics - MRP & DCPNEW - Report from the meeting held on 19-20 May 2026
21 May
UPDATE - Contact Points
18 May
NEW - 19-20 May CMDh agenda
07 May
CORRECTION - Questions and Answers on Variations
Added in April 2026
30 April
UPDATE - Contact Points
29 April
UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation UPDATE - Best Practice Guide for Article 45 and 46 – Paediatric Regulation - EU Worksharing ProcedureUPDATE - CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs (PSUFU procedure) NEW - Report from the meeting held on 21-22 April 2026
28 April
NEW - 24-25 March CMDh Minutes
20 April
NEW - 21-22 April CMDh agenda
07 April
NEW - Ramipril/indapamide PSUR WS SmAR
03 April
UPDATE - Position paper common grounds seen for invalidation/delaying day 0 for variationsUPDATE - Questions and Answers on VariationsUPDATE - Examples for acceptable and not acceptable groupings for MRP/DCP productsUPDATE - Type II variation Preliminary Variation Assessment ReportUPDATE - Chapter 1 - CMDh Best Practice Guide for the allocation of the Mutual Recognition variation number for Type I notifications, Type II variations, grouping and worksharingUPDATE - Chapter 6 - CMDh BPG for the Processing of (Super-)Grouped Applications in the Mutual Recognition ProcedureUPDATE - Questions and answers on the Paediatric RegulationUPDATE - Best Practice Guide for Article 45 and 46 – Paediatric Regulation - EU Worksharing ProcedureUPDATE - D70 Overview AR Template (empty)UPDATE - Overview AR Template (incl. instructions)UPDATE - PAR template (empty) - when prepared based on FARUPDATE - Instructions for RMS when preparing the PAR based on the FARUPDATE - CMDh position paper on the use of Mobile scanning and other technologies to be included in the labelling and/or package leaflet in order to provide information about the medicinal productUPDATE - Annex 2 - Applicant's declaration templateNEW - CMDh Multi-annual Workplan to 2028NEW - CMDh Summary of activities 2025
01 April
NEW - Report from the meeting held on 24-25 March 2026UPDATE - Contact Points
Added in March 2026
31 March
NEW - 24-25 February CMDh Minutes
23 March
NEW - 24-26 March CMDh agenda
04 March
UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric RegulationNEW - Art. 45 PAR Benzocaine / TyrothricinNEW - 2025 Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing proceduresUPDATE - Q&A on BiologicalsNEW - CMDh Multi-Annual Workplan to 2025 - Summary ReportNEW - Report from the meeting held on 24-25 February 2026NEW - Overview of biological active substances of non-recombinant originNEW - 27-28 January CMDh Minutes
03 March
CORRECTION - 09-11 December CMDh minutesCORRECTION - Report from the meeting held on 9-11 December 2025
Added in February 2026
24 February
NEW - 24-25 February CMDh agenda
13 February
UPDATE - Q&A on Generics
10 February
NEW - Art. 46 PAR Elvanse (lisdexamfetamine dimesylate)NEW - Art. 46 PAR Pneumovax and associated names (pneumococcal polysaccharide vaccine)
04 February
NEW - Report from the meeting held on 27-28 January 2026
03 February
NEW - 09-11 December CMDh minutes
Added in January 2026
27 January
UPDATE - Contact PointsNEW - 27-29 January CMDh agenda
19 January
UPDATE - National recommendations for requests to act as RMS
08 January
CORRECTION - CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008 
07 January
UPDATE - ASMF Worksharing Procedure User Guide
Added in December 2025
18 December
UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric RegulationUPDATE - EMA/CMDh Explanatory notes on Variation Application Form - Human medicinal products onlyCORRECTION - Q&A Submission of variations for human medicinal productsUPDATE - Hormone Replacement Therapy - Core SmPCUPDATE - Hormone Replacement Therapy - Core Package Leaflet
17 December
NEW - PSUFU Levonorgestrel intra-uterine devices (LNG-IUDs)NEW - PSUR WS summary AR nebivolol hydrochloride/amlodipine besilateNEW - Art. 45 PAR Mycobutin (rifabutin)NEW - Art. 45 PAR Prothyrid 100 microgram/10 microgram (levothyroxine sodium/liothyronine hydrochloride)NEW - Art. 45 PAR Cynomel 0,025 mg, Thyrotardin inject (liothyronine sodium) / Thybon 20 Henning. Thybon 100 Henning (liothyronine hydrochloride)UPDATE - National recommendations for requests to act as RMSUPDATE - CMDh Best Practice Guide on Variation Worksharing, Chapter 7NEW - Report from the meeting held on 9-11 December 2025NEW - 11-13 November CMDh minutesNEW - Minutes of the 19 November 2025 meeting with Interested Parties
8 December
NEW - 9-11 December CMDh agenda]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/recently-published-history.html#c7757</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/recently-published-history.html#c7757</guid>
                    <pubDate>Tue, 08 Oct 2024 14:35:09 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[Guidance published by Member States on the implementation of the Falsified Medicines Directive  (September 2026)]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/falsified-medicines.html#c5941</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/falsified-medicines.html#c5941</guid>
                    <pubDate>Fri, 18 Aug 2017 13:38:00 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[Meeting 15-17 September: AgendaMeeting 21-22 July 2026: Agenda - MinutesMeeting 23-25 June 2026: Agenda - MinutesMeeting 19-20 May 2026: Agenda - MinutesMeeting 21-22 April 2026: Agenda - MinutesMeeting 24-25 March 2026: Agenda - MinutesMeeting 24-25 February 2026: Agenda - Minutes - Correction 16/09/2026Meeting 27-29 January 2026: Agenda - Minutes]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/agendas-and-minutes.html#c7862</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/agendas-and-minutes.html#c7862</guid>
                    <pubDate>Wed, 21 Jan 2026 13:06:11 +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 7, June 2026Part II placeholder document Article 11 workaround | pdf - Version 1.1, May 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 2026New rules translations of patient facing documents and new template recruitment  - CTIS Info Day 17 June 2026Article 11 workaround: Concept and Supporting Documents - Webinar 15 April 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 2, April 2026
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 2.1, May 2026Recommendation 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[]]></title>
                    <description><![CDATA[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, LT, 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 , sponsors should express their interest by sending the Expression of Interest Template which can also be found as Annex to the FAST-EU Sponsor Guide via e-mail to FAST-EU@hma.eu. Submission windows are provided in the table below. Expression of Interest should indicate whether CTIS submission would be feasible in the first or second half of the relevant month. A response can be expected within 5 business days.
For Italy and Spain please provide the responsible Ethics Committee. The list of Italian Ethics Committees participating in the FAST-EU project is available on the AIFA website and at the following link. For the Spanish Ethics Committees please see the AEMPS website at the following link (see the section “CEIm adheridos a procedimientos de evaluación acelerada”).

MonthSubmission windowResponse June 20-21 May28 MayJuly22-23 June30 JuneAugust22-23 July30 JulySeptember20-21 August28 AugustOctober22-23 September30 SeptemberNovember21-22 October29 OctoberDecember19-20 November27 November
A total of 103 Expressions of interest have been received from the launch of the project with 23 clinical trials already selected for the accelerated assessment. In response to this high level of interest, and due to the substantial number of applications received, participating Member States agreed to accept more applications than initially planned. This collaborative decision underlines the commitment of the National Competent Authorities involved to keep supporting the project’s fast pace and broad participation. The following Reporting Member States have been selected for FAST EU until now:
AustriaBelgiumCzech RepublicDenmarkEstoniaFinland  France Germany  HungaryIreland ItalyLatviaNorwayNetherlandsPoland  PortugalSloveniaSpain  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.

]]></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[]]></title>
                    <description><![CDATA[HMA MANAGEMENT GROUP
The Heads of Medicines Agencies (HMA) Management Group, as endorsed during the Irish Presidency in 2004, has as its main-objectives the co-ordination and facilitation of the operation of HMA, and the supervision and management of the HMA Permanent Secretariat.
The current composition of the HMA Management Group is: 
María Jesús Lamas Díaz (AEMPS, Spain) - Chair  | biographyMomir Radulović (JAZMP, Slovenia) - Vice Chair | biographyRui Santos Ivo (INFARMED, Portugal; Chair EMA Management Board) | biographyThomas Heberer (BVL, Germany) | biographyGünter Waxenecker (AGES, Austria) | biographyKarl Broich (BfArM, Germany) | biographyAimad Torqui - co-opted (CBG-MEB, Netherlands; Vice-chair EMA Management Board) | biographyPresidency of the EU Council: Ireland | Grainne Power (HPRA)]]></description>
                    <link>https://www.hma.eu//about-hma/structure.html#c81</link>
                    <guid>https://www.hma.eu//about-hma/structure.html#c81</guid>
                    <pubDate>Tue, 13 Dec 2022 15:25:00 +0100</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[Alternate: Sandra SchmidtPaul-Ehrlich-Institut (PEI)Paul-Ehrlich-Straße 51-59D-63225 LANGEN]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/about-cmdh/cmdh-composition.html#c3532</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/about-cmdh/cmdh-composition.html#c3532</guid>
                    <pubDate>Thu, 01 Jan 1970 01:00:00 +0100</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Contact]]></title>
                    <description><![CDATA[Contact Points: 
Stefan Berggren (Chair), MPA, SEE-mail: stefan.berggren@lakemedelsverket.seKatharina Högdin (Secretariat), MPA, SEE-mail: katharina.hogdin@lakemedelsverket.se]]></description>
                    <link>https://www.hma.eu//about-hma/working-groups/pie/pie.html#c7873</link>
                    <guid>https://www.hma.eu//about-hma/working-groups/pie/pie.html#c7873</guid>
                    <pubDate>Thu, 01 Jan 1970 01:00:00 +0100</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[CTCG News and Events]]></title>
                    <description><![CDATA[FAST-EU Pilot Demonstrates Europe's Capacity for Accelerated and Coordinated Clinical Trial Authorisation
Three months into the pilot, 15 multinational clinical trials are progressing under accelerated timelines, with the first three procedures completed within the 70-day target
The Clinical Trials Coordination Group (CTCG) operating under the umbrella of the Heads of Medicines Agencies (HMA), and MedEthics EU under the auspices of the European Commission, today publish the first interim results of the FAST-EU pilot initiative (Facilitating and Accelerating Strategic Clinical Trials in the EU).
The pilot already applies the new accelerated procedure and mechanisms proposed by the Commission in the revision of the Clinical Trial Regulation in the Biotech Act, and thus serves as an early operational testbed for the revised clinical trial authorisation procedure. This new procedure aims to deliver a shorter, simpler and more predictable approval process. It does so while maintaining the highest standards of participant safety and data quality. 
Background
Launched in February 2026, FAST-EU is a voluntary pilot implemented within the framework of Regulation (EU) No 536/2014 (Clinical Trials Regulation, CTR). It aims to accelerate the coordinated assessment and authorisation of multinational clinical trial applications across Member States, while fully maintaining scientific, safety and ethical standards. FAST-EU operates entirely within the Clinical Trials Information System (CTIS) and does not alter the legal rights or obligations of any party.
The pilot serves as a practical proof of concept for the European Commission's proposal for an EU Biotech Act, demonstrating the feasibility of the streamlined and time-bound authorisation model for clinical trials. It is also a testimony of the strong commitment of Member States and sponsors to its implementation.
Strong Demand from Sponsors
In the first three months of operation, the FAST-EU Coordination Office received 68 Expressions of Interest from sponsors across Europe and internationally. Of these, 15 procedures were selected for inclusion in the pilot - three in February, four in March, four in April, and four in May 2026. The volume of applications exceeded the originally planned pilot capacity of two procedures per month, reflecting both the strong interest from the sponsor community and the willingness of Member States to step up to the challenge of increased demand.
The 15 selected trials cover a broad range of therapeutic areas, including oncology and haematology (7 trials), neurology and neurodegenerative diseases (2), cardiovascular and pulmonary vascular disease (2), and immunology and inflammatory disease (2). Trials span all development phases, from Phase I to Phase III, and involve on average 7.33 participating Member States per procedure, with individual trials involving up to 14 Member States. 
First Completed Procedures Confirm Feasibility of 70-Day Target
Three procedures have been completed to date, all meeting or closely approximating the 70-calendar-day target set by FAST-EU*1. These results demonstrate that the 70-day timeline is operationally achievable across a diverse range of trial types, indication areas, and Member State constellations. 
Participating Member States and RMS Distribution
Twenty-six Member States and EEA countries are participating in FAST-EU. Reporting Member State distribution reflects the pan-European character of the initiative. RMS roles completed or ongoing include Italy, Denmark, the Netherlands, Germany (PEI), Finland, Poland, Sweden, Spain, Belgium, Norway, and the Czech Republic - with Romania, Hungary, Austria, and Portugal planned for upcoming procedures.
Relevance for the EU Biotech Act
he FAST-EU pilot was conceived in part as a proof of concept for the accelerated and coordinated clinical trial authorisation model anticipated under the EU Biotech Act. The pilot's timeline architecture - parallel validation, timelines based on full weeks, a single consolidated RFI round for Part I and a 70-day overall target - closely mirrors the  European Commission proposal for a revised authorisation procedure in the Biotech Act, aimed at creating a more competitive, agile and predictable European regulatory environment for clinical research.The interim results support the conclusion that this model is operationally feasible within the existing CTR framework, even where certain functionalities such timelines and separate validation processes are not yet supported by CTIS infrastructure. 
Next Steps
Ongoing evaluation will include qualitative findings from structured interviews with Reporting Member States on coordination effort, application of the reliance principle, and challenges for integration of Ethics Committees. A full pilot report will be published upon conclusion.
Sponsors wishing to submit an Expression of Interest for the FAST-EU pilot may contact the FAST-EU Coordination Office at FAST-EU@hma.eu. Further information is available in the FAST-EU External Guidance for Sponsors (Version 1.2, April 2026), published on the CTCG website.
The Clinical Trials Coordination Group (CTCG) is a standing working group of the Heads of Medicines Agencies (HMA), responsible for the operational implementation of the EU Clinical Trials Regulation. MedEthics EU under the auspices of the European Commission is the corresponding coordination body for Ethics Committees across the EU/EEA. 
1^ For one trial a deviation of one day related to the Easter public holiday period was noted and documented.


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 has organised a webinar on 15 April 2026, with more than 500 participants joining the meeting, during which it was explained how to apply this new approach, how to monitor these trials and where to find the supporting documents. It also provide insights into the new approach where to upload translated versions of patient facing documents into CTIS.
Meeting schedule for 2026
DateDate of the weekLocation09-10 February 2026Monday & Tuesday EMA09-10 March 2026Monday & Tuesday Virtual 13-14 April 2026Monday & TuesdayEMA20 May 2026WednesdayVirtual03-04 June 2026Tuesday & Wednesday Cyprus 08-09 July 2026 Wednesday & Thursday Virtual 09-10 September Wednesday & Thursday EMA08-09 October 2026Thursday & Friday Virtual 18-19 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[ 	Vaqta (hepatitis A vaccine) 	End of procedure: 19/12/2013 	Date of publication: 03/06/2014 ]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/paediatric-regulation/assessment-reports/article-46-work-sharing.html#c3750</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/paediatric-regulation/assessment-reports/article-46-work-sharing.html#c3750</guid>
                    <pubDate>Tue, 03 Jun 2014 16:19:00 +0200</pubDate>
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