The newly published platform, developed by NTT DATA, will be the single system for monitoring clinical trials, from submission to evaluation and public registration, for sponsors and regulatory entities in the European Union and the European Economic Area.
Also, European regulation on veterinary medicines also becomes applicable, which stimulates innovation and increases the availability and access to safe, high-quality veterinary medicines for veterinarians, farmers, and pet owners to treat and prevent animal diseases, and supports the EU action against antimicrobial resistance. NTT DATA has developed in cooperation with the EMA three systems required by the Regulation.
NTT DATA works with the European Medicines Agency (EMA) in the development of the Clinical Trials Information System (CTIS), which is launched on 31st of January 2022. CTIS is the business tool of the Clinical Trials Regulation, which harmonises the submission, evaluation, and supervision of the clinical trials in the European Union (EU) and the European Economic Area (EEA). Also, with the European regulation on veterinary medicines being applicable since 28th of January, NTT DATA has developed in cooperation with the EMA three systems required by the Regulation.
The new model and time frame
The tool, developed by NTT DATA, allows:
- Clinical trial sponsors including both academics and pharmaceutical companies to submit their clinical trial data in a common database;
- National competent authorities and ethics committees of EU/EEA countries to assess clinical trials data and supervise clinical trials
- the European Commission to create Union Control Reports
- EMA to administer the system
Clinical trial sponsors, national competent authorities and ethics committees, the European Commission and EMA benefit from secure workspaces for the use of CTIS. For the public, including health professionals and patients, a public website and searchable database is available.
CTIS supports the running of clinical trials in the EU and EEA, with particular benefits for those looking to run multinational trials, since with a single application they can choose to do so in up to 30 countries of the EEA. It also generates benefits for sponsors, including academic researchers, seeking greater cross-border collaboration to improve results and share knowledge. In addition, CTIS eases the publication requirements for clinical trials.
The time frame that is envisaged for the transition to CTIS is 3 years from the launch on January 31, 2022. In the first year, sponsors can choose whether to initiate a clinical trial under the Regulation through CTIS or through previous legislation and pre-existing systems. From 31st January 2023, all applications to start new clinical trials must be submitted through the platform. By 31st January 2025, all ongoing clinical trials a must be transferred to CTIS.
Animal medicine regulation also evolves in safety and quality
On 28 January 2022, the European regulation on veterinary medicines (Regulation (EU) 2019/6) also becomes applicable, which stimulates innovation and increases the availability and access to safe, high-quality veterinary medicines for veterinarians, farmers, and pet owners to treat and prevent animal diseases, and supports the EU action against antimicrobial resistance. NTT DATA has developed in cooperation with the EMA three systems required by the Regulation:
- Union Product Database
- Union Pharmacovigilance Database
- Manufacturing and Wholesale Distribution Database
The Union Product Database is the first central database gathering information on all veterinary medicines authorised in EU/EEA countries. It also enables some post-authorisation procedures. The system has been set up and will be maintained by EMA in collaboration with the Member States and the European Commission. While EMA and the regulatory network are finalising the upload of product data, activities to improve the data quality have also been initiated.
The Union Pharmacovigilance Database is launched as an enhanced and upgraded EudraVigilance Veterinary (EVVet3) system for the exchange and processing of suspected adverse reaction reports related to veterinary medicines authorised in the EEA. EVVet3 is supplemented by an upgraded analytics tool and new functionality to support pharmacovigilance monitoring activities. Integrating all these components, the Union Pharmacovigilance Database is the key tool for the continuous monitoring of the safety of veterinary medicines after they are authorised.
The Manufacturing and Wholesale Distribution Database includes information on the granting, suspension, or revocation by competent authorities of any manufacturing authorisation, wholesale distribution authorisation, certificates of good manufacturing practice and registration of manufacturers, importers and distributors of active substances for both veterinary and human domains. The system launched today is an enhanced and upgraded version of EudraGMDP, the EU database of manufacturing authorisations and certificates of good manufacturing practice, with changes affecting both the veterinary and the human domains.
During the implementation period of the Regulation, the EMA has revised its procedures and regulatory and scientific guidance documents.