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To the attention of clinical trial sponsors (including for academic studies), Contract Research Organisations and Investigators
All ongoing clinical trials in the European Union (EU) authorised under the Clinical Trials Directive 2001/20/EC must be transferred (transitioned) under the regulatory framework of Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC and into the Clinical Trials Information System (CTIS) by 30 January 2025.
This date marks the end of a three-year transition period, which started on 31.01.2022, when the Clinical Trials Regulation (CTR) became applicable in the EU.
Sponsors of clinical trials authorised under the Clinical Trials Directive, which are expected to continue after 30 January 2025, must take into account the time needed for Member States to complete the assessment procedure, which can take up to three months.
To help streamline the process, Member States have implemented an accelerated procedure for the transition of trials to Regulation 536/2014.
Specific guidelines are available on the HMA/CTCG/Key documents list website:
https://www.hma.eu/about-hma/working-groups/clinical-trials-coordination-group.html
Ongoing clinical trials must not be interrupted or terminated during the transition from the previous legal regime, the Clinical Trials Directive, to the Clinical Trials Regulation.
Find out more about transitional trials in the quick guide for sponsors provided by the European Medicines Agency (EMA).
https://www.ema.europa.eu/en/documents/other/sponsors-guide-transition-trials-eudract-ctis-ctis-training-programme-module-23_en.pdf
For more information on how to transition a clinical trial, see the available guidelines and training materials.
https://euclinicaltrials.eu/guidance-and-q-as/?lang=en#qas-transitioning

14.11.2023 Important notification from EMA for clinical trials sponsors Please find below the following message published by the European Medicines Agency regarding the transition of clinical trials authorised under Directive 2001/20/EC to the regulatory framework of Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on interventional clinical trials on medicinal products for human use download document …

06.04.2022 Clinical Trials Coordination Group of HMA published recommendation to sponsors on managing the impact of the war in Ukraine on clinical trials The following recommendations focus on the transfer of trial participants from centres in Ukraine to centres in the EU/EEA within the same multinational clinical trial. The primary objective of ensuring further participation of clinical trial participants is that they have continuous access to the investigational treatment that they are likely to benefit from. In such situation sponsors are encouraged to make necessary arrangements to allow transfer of refugees to study sites in the EU/EEA. CTCG recommendations are detailed in the attached file. download document …

31.03.2022 To the attention of persons concerned In view of the disruptions caused by the Russian invasion of Ukraine, the European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) are issuing initial advice for sponsors on how to manage the conduct of clinical trials in this situation – EMA 30.03.2022 press release. download document …

24.10.2016 To the attention of persons concerned – useful links www.clinicaltrialsregister.eu www.who.int/ictrp/en www.bioetica-medicala.ro

24.10.2016 To the attention of persons concerned – with respect to VHP (Voluntary Harmonised Procedure) procedure Given Romanias agreement to take part in the VHP procedure as Concerned Member State since 2008 and as Reference Member State as of 2015, please be advised on the following: – Detailed information on the VHP procedure for harmonised assessment by Concerned Member States of clinical trial applications and important amendment applications, respectively, is available in the CTFG/VHP/2016/Rev6 Guidelines of June 2016: (http://www.hma.eu) – Fees for NAMMD operations are paid in accordance with national legislation (Order of the Minister of Health no. 888/2014), by national submission to the NAMMD of a formal application for approval of a clinical trial/important amendment, for response, regardless of the outcome of scientific assessment by the VHP procedure (approval/rejection/withdrawal by the applicant during or after the VHP assessment). – In case fee payment is declined, the risk for the sponsor is permanent exclusion from future VHP procedures. Details on procedure fee management may also be found in the VHP guideline CTFG/VHP/2016/Rev6 of June 2016.

24.10.2016 To the attention of parties concerned – with respect to submission of the ANNUAL SAFETY REPORT (DSUR-Development Safety Update Report) – the Annual Safety Report (in the format provided in the ICH E2F/ EMA/CHMP/ICH/309348/2008 Guideline) is submitted to the NAMMD electronically (as a CD, DVD or memory stick), accompanied by a cover letter, preferably in Romanian, indicating the name of the investigational medicinal product tested and the list of clinical trials on the respective product conducted in Romania.

22.04.2014 To the attention of stakeholders Please be advised on approval of Scientific Council Decision no. 2/2014 on Regulations for authorisation of units able to perform clinical trials in the field of the medicinal product for human use on 22 April 2014. Therefore, the applications for authorisation of units able to perform clinical trials on medicinal products for human use shall be submitted to the NAMMD at least 3 months prior to expiry of the previous authorisation validity. Schedule for submission of applications: Friday, 9:45-13:45.