• Important notification

    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.

  • Important notification

    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.

  • Important notification

    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.

  • Important notification

    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.