{"id":9674,"date":"2023-01-03T15:31:46","date_gmt":"2023-01-03T12:31:46","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?page_id=9674"},"modified":"2026-03-05T17:23:21","modified_gmt":"2026-03-05T14:23:21","slug":"informatii-de-interes-pentru-sponsori","status":"publish","type":"page","link":"https:\/\/www.anm.ro\/en\/medicamente-de-uz-uman\/informatii-de-interes-pentru-sponsori\/","title":{"rendered":"Information of interest to sponsors"},"content":{"rendered":"

<\/a> <\/a><\/p>\n

The \u201dClinical Trial Information System (CTIS) \u2013 Sponsor handbook\u201d \u2013 revised version<\/strong><\/span>
\n\u25ba Brief presentation \u2013 9 July 2025, 15:30 CEST.
\nOn 9 July 2025, the EMA shall publish the revised version of the Clinical Trial Information System (CTIS) Sponsor Handbook on its website and, to support the transition to the new format, the EMA organises a brief presentation on the CTIS on Wednesday, 9 July 2025, at 15:30 CEST, where the new structure and main features of the revised version of the handbook shall be presented, while also providing an opportunity for asking questions.
\nThis updated version of the sponsor handbook shall replace all previous sponsor training modules and shall serve as the definitive reference for sponsor users of the CTIS.
\nThe update of the sponsor training materials has been carried out in response to the feedback from stakeholders, with the aim of improving its usability and facilitating navigation of the system. A \u2018stakeholder focus group\u2019, created under the ACT EU Multi-Stakeholder Platform, reviewed and validated the new materials in order to make sure that they met the needs of the sponsor community.<\/p>\n

To the attention of clinical trial sponsors (including for academic studies), Contract Research Organisations and Investigators<\/strong><\/span>
\nAll 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.
\nThis 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.
\nSponsors 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.
\nTo help streamline the process, Member States have implemented an accelerated procedure for the transition of trials to Regulation 536\/2014.
\nSpecific guidelines are available on the HMA\/CTCG\/Key documents list website:
\nhttps:\/\/www.hma.eu\/about-hma\/working-groups\/clinical-trials-coordination-group.html<\/a>
\nOngoing 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.
\nFind out more about transitional trials in the quick guide for sponsors provided by the European Medicines Agency (EMA).
\nhttps:\/\/www.ema.europa.eu\/en\/documents\/other\/sponsors-guide-transition-trials-eudract-ctis-ctis-training-programme-module-23_en.pdf<\/a>
\nFor more information on how to transition a clinical trial, see the available guidelines and training materials.
\nhttps:\/\/euclinicaltrials.eu\/guidance-and-q-as\/?lang=en#qas-transitioning<\/a><\/p>\n\n\n\n\n\n\n\n\n\n
14.11.2023<\/strong>
\nImportant notification from EMA for clinical trials sponsors <\/strong>
\nPlease 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
\ndownload document \u2026<\/a>
\n<\/tr>\n
06.04.2022<\/strong>
\nClinical Trials Coordination Group of HMA published recommendation to sponsors on managing the impact of the war in Ukraine on clinical trials<\/strong>
\nThe 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.
\nThe 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.
\nIn such situation sponsors are encouraged to make necessary arrangements to allow transfer of refugees to study sites in the EU\/EEA.
\nCTCG recommendations are detailed in the attached file.
\ndownload document \u2026<\/a>
\n<\/tr>\n
31.03.2022<\/strong>
\nTo the attention of persons concerned<\/strong>
\nIn 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.
\ndownload document \u2026<\/a>
\n<\/tr>\n
24.10.2016<\/strong>
\nTo the attention of persons concerned \u2013 useful links<\/strong>
\n www.clinicaltrialsregister.eu<\/a>
\n www.who.int\/ictrp\/en<\/a>
\n www.bioetica-medicala.ro<\/a><\/td>\n<\/tr>\n
24.10.2016<\/strong>
\nTo the attention of persons concerned – with respect to VHP (Voluntary Harmonised Procedure) procedure<\/strong>
\nGiven 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:
\n– 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<\/a>)
\n– 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).
\n– 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.<\/td>\n<\/tr>\n
24.10.2016<\/strong>
\nTo the attention of parties concerned – with respect to submission of the ANNUAL SAFETY REPORT (DSUR-Development Safety Update Report)<\/strong>
\n– 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.<\/td>\n<\/tr>\n
22.04.2014<\/strong>
\nTo the attention of stakeholders<\/strong>
\nPlease 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.
\nTherefore, 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.
\nSchedule for submission of applications: Friday, 9:45-13:45.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

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