EMA reports steady rise in clinical trial applications registered in CTIS portal

Regulatory NewsRegulatory News | 23 August 2022 | By

Nearly 195 clinical trial applications (CTAs) have been submitted to the European Medicine Agency’s (EMA) Clinical Trial Information System (CTIS) portal through July, marking a substantial increase from a month earlier, according to a 23 August report from the agency.
 
However, during the same period, most applications (224) were still being registered in the older EudraCT database. (RELATED: EMA reports slow uptick in clinical trial applications submitted via CTIs portal, Regulatory Focus 3 August 2022).
 
EMA is encouraging clinical sponsors to submit their applications to the portal, asserting that the benefits of this new system are improved information sharing, collective decision-making on clinical trials, increased transparency on clinical tails and ensuring high safety standards for patient. The system, which is being implemented as part of the Clinical Trials Regulation (CTR) allows sponsors to apply to run clinical trials throughout the EU at the same time using the same documentation.
 
The number of CTIS registrations grew from nine in February 2022, 18 in March, 29 In April, 35 in May, 39 in June and 58 in July.
 
Of the 195 CTAs submitted in CTIS during the first six months since the launch of the system on 31 January 2022, 188 are initial clinical trial applications, four are substantial modification applications and three include substantial additions from concerned Member States.
 
Since January, 43 decisions were rendered on applications submitted to the CTIS portal from mix of non-commercial entities and commercial sponsors. For commercial sponsors, 12 decisions were for applications to market the treatment in one member state while nine were to market the drug multinationally.
 
Of the 43 decisions, 16 were for Phase II trials, followed by 10 for Phase IV trials and six for Phase III trials.
 
In terms of the therapeutic areas, ten decisions were made for neoplasm treatments, followed by six decisions each for treatments for viruses and cardiovascular diseases. Several therapeutic areas, including diseases of the skin and connective tissues, nutritional and metabolic diseases, musculoskeletal diseases, immune system diseases and digestive system diseases, had three decisions issued.
 
Denmark received the highest number of CTAs at ten, followed by Spain at eight, and five for Belgium.
 
Starting in January 2023, CTIS will replace the EudraCT portal and clinical trial sponsors must use the CTIS portal to apply for authorization to run a clinical trial. The CTIS portal was launched in January and registration is still voluntary.
 
EMA report on KPIs
 

 

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