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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>Fri, 28 Aug 2026 09:03:10 +0200</pubDate>
            
                <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>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[Verorab (rabies virus, inactivated)FR/W/0028/pdWS/001End of procedure: 17/01/2024Date of publication: 03/04/2024FR/W/0028/pdWS/002End of procedure: 10/04/2026Date of publication: 27/05/2026]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/paediatric-regulation/assessment-reports/article-46-work-sharing.html#c7887</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/paediatric-regulation/assessment-reports/article-46-work-sharing.html#c7887</guid>
                    <pubDate>Tue, 26 May 2026 13:22:42 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[ 	Valtrex (valaciclovir) 	End of procedure: 09/12/2019 	Date of publication: 09/03/2020 ]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/paediatric-regulation/assessment-reports/article-46-work-sharing.html#c6595</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/paediatric-regulation/assessment-reports/article-46-work-sharing.html#c6595</guid>
                    <pubDate>Wed, 26 Feb 2020 10:44:01 +0100</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[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  (July 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[CMDh letter for MAHs for medicinal products containing active ingredients in the form of Mesilates, Isetionates, Tosilates or Besilates (February 2008)]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/about-cmdh/contacts-with-representative-organisations.html#c7905</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/about-cmdh/contacts-with-representative-organisations.html#c7905</guid>
                    <pubDate>Tue, 21 Jul 2026 13:00:04 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[National feesPlease inform the CMDv secretariat if you find a link that does not work
Austria (AT - EN version), Belgium (BE), Bulgaria (BG), Croatia (HR), Cyprus (CY), Czech Republic (CZ, EN version), Denmark (DK), Estonia (EE, EN version), Finland (FI), France (FR, EN version), Germany - PEI (DE), Germany - BVL (DE), Greece (EL), Hungary (HU), Iceland (IS), Ireland (IE), Italy (IT, EN version), Latvia (LV), Liechtenstein (LI - No fees regarding DCP/MRP applications due to an agreement between LI and AT. This agreement allows LI to accept marketing authorisations issued by the Austrian authority (AGES) for the MRP/DCP procedures, provided the applicant wishes to have LI included), Lithuania (LT), Luxembourg (LU), Malta (MT), Netherlands (NL), Norway (NO), Poland (PL-PL'), Portugal (PT), Romania (RO), Slovakia (SK), Slovenia (SI), Spain (ES), Sweden (SE), United Kingdom (UK NI).]]></description>
                    <link>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/general-information-on-applications.html#c5968</link>
                    <guid>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/general-information-on-applications.html#c5968</guid>
                    <pubDate>Thu, 22 Nov 2018 00:00:00 +0100</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[CMDh Multi-Annual Workplan to 2020 (April 2016)]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/about-cmdh/cmdh-activities.html#c5420</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/about-cmdh/cmdh-activities.html#c5420</guid>
                    <pubDate>Mon, 16 May 2016 11:20:00 +0200</pubDate>
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