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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>Mon, 04 May 2026 18:42:50 +0200</pubDate>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[SUBSCRIBE to NEWSLETTER
30/4/2026      HMA newsletter April 2026
31/3/2026      HMA newsletter March 2026
26/2/2026      HMA newsletter February 2026
27/1/2026      HMA newsletter January 2026
22/12/2026    HMA newsletter December 2025
3/12/2025      HMA newsletter November 2025
20/10/2025    HMA newsletter October 2025
24/09/2025    HMA newsletter September 2025
15/07/2025    HMA newsletter July 2025
17/06/2025    HMA newsletter June 2025
14/05/2025    HMA newsletter May 2025
16/04/2025    HMA newsletter April 2025
16/04/2025    HMA Launches its Newsletter to provide updates about its coordinated work in the European regulatory network]]></description>
                    <link>https://www.hma.eu//about-hma/newsletter/newsletters.html#c7736</link>
                    <guid>https://www.hma.eu//about-hma/newsletter/newsletters.html#c7736</guid>
                    <pubDate>Thu, 10 Apr 2025 15:28:08 +0200</pubDate>
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                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[Contact Points]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/contact-points.html#c4478</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/contact-points.html#c4478</guid>
                    <pubDate>Thu, 07 Oct 2021 14:43:00 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[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
Added in November 2025
27 November
NEW - Presentations from the 19 November 2025 meeting with Interested PartiesNEW - Art. 46 PAR Cleviprex (clevidipine)NEW - Art. 46 PAR Botox (botulinum toxin type A)NEW - Art. 46 PAR Pentavac (Corynebacterium diphtheriae toxoid, Clostridium tetani toxoid, Haemophilus influenzae type B polysaccharide, Bordetella pertussis, filamentous hemagglutinin, Bordetella pertussis toxoid, poliovirus type 1, strain Mahoney, inactivated, poliovirus type 3, strain Saukett, inactivated, poliovirus type 2, strain MEF-1, inactivated)UPDATE - Instructions for RMS when preparing the PAR based on the FARUPDATE - PAR template (empty) - when prepared based on FARUPDATE - CMDh Best Practice Guide on the compilation of the dossier for New Applications submitted in Mutual Recognition and Decentralised ProceduresUPDATE - D70 Overview AR Template (empty) 
19 November
NEW - Report from the meeting held on 11-13 November 2025
17 November
NEW - 14-15 October CMDh minutes
10 November
NEW - 11-13 November CMDh agenda
07 November 
UPDATE - Contact Points
04 November 
UPDATE - Guidance on the application of the revised variations framework
Added in October 2025
23 October 
MOVED - National information on MAH transfersNEW - Q&A Post-BrexitNEW - D70 Overview AR Template (incl. instructions)NEW - Art. 46 PAR Riamet (artemether / lumefantrine)NEW - Art. 46 PAR Panzyga and associated names (human normal immunoglobin (IVIg))NEW - Art. 46 PAR Xalatan / Latanoprost Viatris (latanoprost)NEW - Art. 46 PAR Hiberix (haemophilus influenzae type b polysaccharide (PRP) conjugated to tetanus toxoid (TT))NEW - Recommendations on submission dates in 2026 for Applications of the MRPNEW - Recommendations on submission dates in 2026 for Applications of the DCP
22 October
NEW - Report from the meeting held on 14-15 October 2025UPDATE - Guidance on eSubmissions
21 October
UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
17 October
NEW - 16-18 September CMDh minutes
13 October
NEW - 14-15 October CMDh agenda
Added in September 2025
25 September
NEW - Art. 46 PAR HavrixNEW - Art. 45 PAR Pheniramine maleate, naphazoline hydrochlorideNEW - Overview referral timetables 2026UPDATE - Criteria for selection of products for SmPC HarmonisationUPDATE - RMS Validation Checklist for human medicinal products in DCPUPDATE - Common request form for RMS in DCPNEW - 22-23 July CMDh minutesNEW - Q1-Q2 2025 Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures
24 September
NEW - Report from the meeting held on 16-18 September 2025UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
22 September
UPDATE - Guidance on the application of the revised variations framework
15 September
NEW - 16-18 September CMDh agenda
09 September
UPDATE - Contact Points
Added in August 2025
27 August
UPDATE - Contact Points
11 August
Update - List of safety concerns per approved Risk Management Plan (RMP) of active substances per product
08 August
NEW - HaRP assessment reports (Acetylcysteine, Adenosine, Ambroxol, Captopril, Combined Hormonal Contraceptives, Chlormadinone acetate/Ethinylestradiol, Flurbiprofen, Gabapentin, Gliclazide, Lactulose, Levosimendan, Linezolid, Loperamide, Olmesartan/Amlodipine/Hydrochlorthiazide, Piperacillin/Tazobactam, Warfarin)
01 August
NEW - Art. 46 AR Repevax, Adacel-Polio, Triaxis-PolioUPDATE - Member States Recommendations on the Cover Letter for New Applications submitted through MRP/DCPUPDATE - Cover letter template for renewalsUPDATE - Cover letter for Variation Applications in the Mutual Recognition ProcedureUPDATE - Template cover letter for new applications submitted through MRP/DCPUPDATE - Overview AR Template (incl. instructions)UPDATE - D70 Overview AR Template (empty)NEW - Instructions for RMS when preparing the PAR based on the FARNEW - PAR template (empty) - when prepared based on FAR]]></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[List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation]]></title>
                    <description><![CDATA[List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation (April 2026)]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/paediatric-regulation/article-45-and-previous-worksharing.html#c2202</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/paediatric-regulation/article-45-and-previous-worksharing.html#c2202</guid>
                    <pubDate>Thu, 30 Sep 2021 17:00:00 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[Paediatric Regulation: Article 45 and Article 46

Best Practice Guide for Article 45 and 46 – Paediatric Regulation - EU Worksharing Procedure (April 2026) [Track version]]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/paediatric-regulation/guidance-documents.html#c1718</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/paediatric-regulation/guidance-documents.html#c1718</guid>
                    <pubDate>Thu, 30 Sep 2021 15:00:00 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs (PSUFU procedure) (April 2026) [Track version] ]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/pharmacovigilance/psur/psur-follow-up.html#c7152</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/pharmacovigilance/psur/psur-follow-up.html#c7152</guid>
                    <pubDate>Mon, 23 Jan 2023 16:35:55 +0100</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[CMDH PRESS RELEASES 2026]]></title>
                    <description><![CDATA[Report from the meeting held on 21-22 April 2026Report from the meeting held on 24-25 March 2026Report from the meeting held on 24-25 February 2026Report from the meeting held on 27-28 January 2026]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/press-releases.html#c7863</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/press-releases.html#c7863</guid>
                    <pubDate>Tue, 03 Feb 2026 17:20:16 +0100</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[Meeting 21-22 April 2026: AgendaMeeting 24-25 March 2026: Agenda - MinutesMeeting 24-25 February 2026: Agenda - MinutesMeeting 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[]]></title>
                    <description><![CDATA[CMDh Multi-annual Workplan to 2028 (March 2026)]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/about-cmdh/cmdh-activities.html#c7875</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/about-cmdh/cmdh-activities.html#c7875</guid>
                    <pubDate>Wed, 01 Apr 2026 10:53:14 +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, 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 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>
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