Стартиране на Регламент (ЕС) № 536/2014 относно клиничните изпитвания на лекарствени продукти за хуманна употреба

Стартиране на Регламент (ЕС) № 536/2014 относно клиничните изпитвания на лекарствени продукти за хуманна употреба

Уважаеми членове,

От днес започва да се прилага Регламент (ЕС) № 536/2014 относно клиничните изпитвания на лекарствени продукти за хуманна употреба, и за отмяна на Директива 2001/20/ЕО.

По силата на чл. 15, ал. 2 от Закона за нормативните актове Регламентът ще има предимство пред българското законодателство, което му противоречи.

Споделяме Ви съобщението на ЕМА във връзка с Регламента:

On Monday 31st January 2022 at 9:00 a.m. CET, the Clinical Trials Information System (CTIS) has gone live. CTIS is the backbone of the Clinical Trials Regulation that will harmonise the assessment and supervision of clinical trials in the EU and the EEA.

To access CTIS, sponsors can visit the public Clinical Trials website at https://euclinicaltrials.eu/home. The login link for the secure workspaces is at the top right of this website. The “CTIS for sponsors” page provides key information and links for sponsor users.

Sponsor users can read the User Access Management Quick guide for information on getting started with CTIS. Users are encouraged to review the CTIS online modular training programme for information on how to use CTIS. Sponsors can also consult the CTIS Sponsor Handbook. Sponsors are reminded that they can make use of a transition period for submitting clinical trials to CTIS. 

Patients, healthcare professionals and the general public can also access the public Clinical Trials website at euclinicaltrials.eu. When clinical trial applications have been submitted through CTIS and authorised by Member States, they will be openly accessible via the “Search clinical trials page”. The public searchable database will gradually contain more information as sponsors and Member States use it to initiate and oversee clinical trials.

The Clinical Trials Regulation and CTIS represent one of the most ambitious regulatory projects of the European medicines regulatory network. The development of CTIS involved the joint effort and dedication of Member State national competent authorities and ethics committees, clinical trial sponsors representing commercial enterprises (including SMEs) and academia, representatives of patients and healthcare professionals and members of the general public, EMA staff and contractors, the European Commission and HMA. The Clinical Trials Regulation and CTIS will strengthen clinical trials in the EU, ensuring better outcomes for patients and supporting the attractiveness of the European Union as a location for clinical research.

  

С уважение,

УС на БАКП