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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, 19 Jun 2026 15:07:10 +0200</pubDate>
            
                <item>
                    <title><![CDATA[HMPWG Reports]]></title>
                    <description><![CDATA[Reports from meetings

26-27 February 2026, Limassol (Cyprus): report | pdfAdopted in June 202627 March 2025, Virtual, Warsaw (Poland): report | pdfAdopted in February 202621 November 2024, Virtual, Bonn (Germany): report │ pdfAdopted in March 202525-26 June 2024, Virtual, Bruges (Belgium): report | pdfAdopted in November 202418 October 2023, Virtual, Vienna (Austria): report | pdfAdopted in June 202429-30 March 2023, Uppsala (Sweden): report | pdfAdopted in October 202327-28 October 2022, Rome (Italy): report | pdfAdopted in March 202312-13 May 2022, Paris (France): report | pdfAdopted in October 202210 November 2021, Ljubljana (Slovenia): report | pdfAdopted by written procedure in January 202228 January 2021, Lisbon (Portugal): report | pdfAdopted by written procedure in April 202101-02 September 2020, Bonn (Germany) report | pdfAdopted by written procedure in October 202024-25 October 2019, Bucharest (Romania): report | pdfAdopted by written procedure in December 201923-24 May 2019, Bucharest (Romania): report | pdfAdopted in October 201918-19 Oct 2018, Vienna (Austria): report | pdfAdopted by written procedure in February 201917-18 May 2018, Berlin (Germany): report | pdf5-6 December 2017, Uppsala (Sweden): report | pdf26-27 June 2017, Gozo (Malta): report | pdf10-11 November 2016, Bern (Switzerland): report | pdfAdopted by written procedure in January 201714-15 April 2016, Utrecht (The Netherlands): report | pdfAdopted by written procedure in June 201611-12 November 2015, Utrecht (The Netherlands): report | pdfAdopted by written procedure in January 201628-29 May 2015, Strasbourg (France): report | pdf4-5 December 2014, Rome (Italy): report | pdf5-6 June 2014, Paris (France): report | pdfRevision to Public Report | pdf21-22 November 2013, Bonn (Germany): report | pdf30-31 May 2013, Dublin (Ireland): report | pdf23 October 2012, Gdansk (Poland): report | pdf5-6 June 2012, Copenhagen (Denmark): report | pdf7-8 June 2011, Budapest (Hungary): report | pdf
Other reports
HMPWG Report on the Regulatory Status of Homeopathic Medicinal Products for Human Use in EU/EEA Countries – Update – 2022 | pdfAdopted by consensus at the 36th HMPWG meeting (29-30 March 2023) under the Swedish PresidencyHMPWG Report on the Regulatory Status of Homeopathic Medicinal Products for Human Use in EU And EFTA Countries | pdfAdopted by written procedure in February 2017]]></description>
                    <link>https://www.hma.eu//about-hma/working-groups/homeopathic-medicinal-products-working-group/homeopathic-medicinal-products-working-group-hmpwg.html#c6613</link>
                    <guid>https://www.hma.eu//about-hma/working-groups/homeopathic-medicinal-products-working-group/homeopathic-medicinal-products-working-group-hmpwg.html#c6613</guid>
                    <pubDate>Tue, 24 Oct 2023 11:10:00 +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 SeptemberNovember22-23 October30 OctoberDecember19-20 November27 November
A total of 83 Expressions of interest have been received from the launch of the project with 19 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  Hungary ItalyNorwayNetherlandsPoland  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[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 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[Clock Start Dates DCP 2027-2028]]></title>
                    <description><![CDATA[Clock Start Dates DCP 2027-2028]]></description>
                    <link>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/applications-for-marketing-authorisation/clock-start-dates.html#c7824</link>
                    <guid>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/applications-for-marketing-authorisation/clock-start-dates.html#c7824</guid>
                    <pubDate>Mon, 15 Sep 2025 09:45:11 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[27 - 28 May 2026, Paphos (Cyprus) - 124th HMA Meeting I Stakeholders information: report | pdf]]></description>
                    <link>https://www.hma.eu//about-hma/meetings/meeting-reports.html#c7896</link>
                    <guid>https://www.hma.eu//about-hma/meetings/meeting-reports.html#c7896</guid>
                    <pubDate>Tue, 09 Jun 2026 13:45:44 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[24 February 2026, Virtual (Cyprus) - 123rd HMA Meeting I Stakeholders information: report | pdf]]></description>
                    <link>https://www.hma.eu//about-hma/meetings/meeting-reports.html#c7895</link>
                    <guid>https://www.hma.eu//about-hma/meetings/meeting-reports.html#c7895</guid>
                    <pubDate>Thu, 28 May 2026 09:34:50 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[2026]]></title>
                    <description><![CDATA[]]></description>
                    <link>https://www.hma.eu//about-hma/meetings/meeting-reports.html#c7894</link>
                    <guid>https://www.hma.eu//about-hma/meetings/meeting-reports.html#c7894</guid>
                    <pubDate>Thu, 28 May 2026 09:34:50 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Post Marketing Procedures]]></title>
                    <description><![CDATA[Guidance documents - Regulation (EU) 2019/6
Best practice guide for changing the reference member state
Guidance for marketing authorisation transfer - National requirements
Guidance for Management of Post-Authorisation Procedures and Pharmacovigilance Activities after Partial Marketing Authorisation Transfer at National Level Following Mutual Recognition or Decentralized Procedure or subsequent Recognition Procedure (so-called Partial MAH Transfer)]]></description>
                    <link>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/post-marketing-procedures.html#c6026</link>
                    <guid>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/post-marketing-procedures.html#c6026</guid>
                    <pubDate>Wed, 23 Aug 2023 12:17:00 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Q&A on transitional arrangements]]></title>
                    <description><![CDATA[
Q&A on transitional arrangements
CMDv has prepared a Q&A document in order to assist both MAHs and NCAs in the management of the transition between the requirements of Directive 2001/82/EC and Regulation (EU) 2019/6.Several items are developed in this document as renewals, update of QRD templates and transition from PSUR to signal management.This document has also been updated with new developments, for instance the transition from the DDPS to the PSMF.
Q&A on transitional arrangements (link)
Additional informationEMA: Q&A on renewals (link)EMA: publication of version 9.1 of the QRD templates (link)EC: Commission Notice on marketing authorisations for veterinary medicinal products for which the expiry of the 5-year period of validity falls on or after the date of entry into application of Regulation (EU) 2019/6 2021/C 274/02 (link) ]]></description>
                    <link>https://www.hma.eu//veterinary-medicines/cmdv/implementation-of-the-vmp-regulation.html#c6810</link>
                    <guid>https://www.hma.eu//veterinary-medicines/cmdv/implementation-of-the-vmp-regulation.html#c6810</guid>
                    <pubDate>Fri, 30 Sep 2022 19:33:00 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Public assessment report]]></title>
                    <description><![CDATA[Public assessment report
For the “Best Practice guide for Production and Publication of Public Assessment Reports”, please refer to the section Authorisation Procedures]]></description>
                    <link>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/post-marketing-procedures/variations.html#c7893</link>
                    <guid>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/post-marketing-procedures/variations.html#c7893</guid>
                    <pubDate>Thu, 28 May 2026 09:34:50 +0200</pubDate>
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