31.01.2022
To the attention of interested persons
An EU4Health Joint Action for the rapid assessment of multinational COVID-19 trials will start in February 2022.
To provide potential clinical trial developers and sponsors with information about this joint action, the coordinators and the steering committee have organised an informative session for stakeholders, which will take place on 3 February, from 10:00 to 12:00.
The scope is limited to COVID-19 therapeutic trials submitted under the Clinical Trials Regulation (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)
Registration for this event can be done by accessing the following link:
EU4H-2021-JA-01
Link: https://scic.ec.europa.eu/ew/register/dgscic/JA_02_22/e/lk/g/36170/k/
The deadline for registration is 31 January 2022.
Attached: the Agenda of the event of 3 February and the login instructions.
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24.08.2020
To the attention of Contract Research Organisations
In the context of the COVID-19 pandemic, the NAMMDR stated on 17.03.2020 that it considers prioritization of the assessment of clinical trials with medicinal products for the treatment of the COVID-19 infection. Given the large number of requests, the expected deadline for completion of the assessment of a COVID-19 trial is changing and will be of 14 to maximum 21 calendar days (Phase III trials shall be considered a priority).
Please note that, for this type of trials as well, the NAMMDR encourages the use of the EU coordinated assessment through the VHP procedure; in this case, the procedure timetable will be established in agreement with the other Member States.

04.08.2020
To the attention of interested persons
EMA press release on the Global regulatory workshop on COVID-19 therapeutics #2: agreement on acceptable endpoints for clinical trials
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01.07.2020
To the attention of interested persons
EMA press release: International regulators provide guiding principles for COVID-19 clinical trials
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18.06.2020
To the attention of interested persons
We hereby inform you that starting with 18.06.2020, the submission of applications and documents to the Clinical Trials Directorate through the NAMMDR Registry Service can be resumed, on Mondays and Wednesdays between 10.30 and 12.30.

03.06.2020
To the attention of interested persons
List of references of observational studies of chloroquine and hydroxychloroquine in COVID-19 patients
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09.04.2020
To the attention of interested persons
In addition to the NAMMDR important notification published on 18.03.2020 on submission of documents, requiring limitation of the Registry Service’s activity, to the utmost extent possible, here are some clarifications about streamlining the document reception activity of the Clinical Trials Directorate (DSC).
These refer to the following:
The submission of documents to the attention of the DSC shall be done as follows:
1. electronically, as follows:
– letters of intent, payment forms and various notifications shall be sent to registratura@anm.ro;
– the documentation related to substantial amendments or clinical trials shall be sent directly to the DSC, using the Upload platform, selecting the Clinical Trials Directorate as the recipient, mentioning the registration number written in the payment confirmation; the documentation shall be sent by archive.
– the documentation related to authorisation of healthcare facilities as clinical trial sites shall be submitted directly to the DSC, using the Upload platform, mentioning the full name of the healthcare facility and the valid contact e-mail address;
– the documentation accompanying notifications shall be submitted directly to the DSC, using the Upload platform, selecting the Clinical Trials Directorate as the recipient, with the specification Notification + brief summary, e.g. DSUR, unimportant amendment etc.
2. By regular mail or courier (in case large documentation is transmitted, exceeding the loading capacity on the platform or if the above is not feasible)
Please note that submission through the CESP or PCUe is not applicable for the Clinical Trials Directorate.

09.04.2020
To the attention of companies conducting clinical trials
Following the issuance of Order 74553/07.04.2020 on amendment and supplementation of Order 74527 / 23.03.2020 issued by Dr Raed Arafat, Action Commander, Secretary of State, Head of the Emergency Department, on establishment of measures required to limit spread of the SARS-Cov-2 virus infection to public and private healthcare facilities, the period mentioned in the notification of 25.03.2020 is extended for the entire duration of the state of emergency.

25.03.2020
To the attention of Contract Research Organizations
Please be advised on the measures established under Order 74527 / 23.03.2020 issued by Dr Raed Arafat, Action Commander, Secretary of State, Head of the Emergency Department, on establishment of measures required to limit spread of the SARS-Cov-2 virus infection to public and private healthcare facilities, which bears significant impact on the approved clinical trial protocols and implicitly on schedules for patients’ visits to clinical research centres at public and private healthcare sites.
In this context, for the term specified in the above Order (14 days starting with 24.03.2020), scheduled visits of subjects enrolled in clinical trials will no longer be allowed, unless deemed an emergency by the doctor (main investigator) on a case-by-case basis, any delay in the respective case likely to affect the subject’s/patient’s safety.
For all other non-emergency situations, the NAMMDR strongly recommends the following:
– visit rescheduling or replacement with telephone consultations;
– finding solutions for medication delivery to patients at home;
– remote monitoring;
– delay initiation of new clinical trials or new research centres.

18.03.2020
To the attention of interested persons
Supplementing NAMMDR notification of 12.03.2020 on submission of documents in the current epidemiological context requiring limitation to the utmost extent possible of Registry Service work, please be advised on specific details aimed to streamline admission of documents addressed to the Clinical Trials Directorate (CTD).
Therefore, please note:
Documents to CTD attention may be admitted as follows:
1. electronically, as follows:
– letters of intent, payment forms and various notifications are to be sent to registratura@anm.ro;
– documentation related to important amendments or clinical trial are to be sent directly to the CTD, using the Upload platform, to aurora.nicula@anm.ro, with specification of the registration number provided in the confirmation of payment;
– documentation related to authorisation of healthcare facilities as clinical trial sites are to be submitted directly to the CTD, using the Upload platform to aida.goran@anm.ro, with specification of the full name of the healthcare facility and the valid contact email address;
– documentation accompanying notifications is to be submitted directly to the CTD, using the Upload platform, to aurora.nicula@anm.ro, with the specification Notification + brief summary, e.g. DSUR, non-important amendment etc.
2. by regular mail or courier (if the above is not feasible)
Please note that submission using CESP or PCUe is not applicable for the Clinical Trials Directorate.

17.03.2020
To the attention of Contract Research Organisations
In the context of the COVID-19 pandemic, the NAMMDR hereby advises on its plan to prioritise assessment of clinical trials with medicines for the treatment of COVID-19 infection; depending on the number of applications and the phase of the trial (Phase III trials shall be considered a priority), the deadline for completion of assessment is expected to not exceed 7 days at most.
Please note that, for this type of trials as well, the NAMMDR encourages use of EU coordinated assessment through the VHP procedure; in such cases, the procedure timetable is established in agreement with the other Member States.

13.03.2020
To the attention of Contract Research Organisations conducting clinical trials in Romania
The current epidemiological context requires measures for public protection, patients / subjects enrolled in clinical trials included.
Therefore, the NAMMDR requests companies conducting clinical trials in Romania to undertake the following:
– establish the potential impact of general protection measures against the COVID-19 pandemic on ongoing activities within each clinical trial;
– notify the NAMMDR on their specific measures plan; on a case-by-case basis, these may be considered emergency safety measures with direct implementation.