Convergence: EU official says no delay to CTIS implementation, despite industry concerns

Regulatory NewsRegulatory News | 15 September 2022 |  By 

PHOENIX, AZ – Country-specific requirements that diverge from the Clinical Trials Regulation (CTR) and the lack of a forum for resolving issues with the Clinical Trial Information System (CTIS) portal were among the key issues industry representatives brought to a session at RAPS Convergence 2022.
Another problem is that the portal does not flag or send information to sponsors when new information is received, so sponsors must check frequently for updates.
In the meantime, an official with the European Medicines Agency (EMA) said that fixing some of the technical glitches associated with the CTIS is a priority. Starting on 31 January 2023, CTIS will replace the EudraCT portal and clinical trial sponsors will be required to use the portal to apply for authorization to run a clinical trial.
Despite that impending requirement, only a small percentage of trials are registered in the system. According to session moderator Kirsten Messmer, a senior research analyst with Agency IQ, about 10% of trials are currently registered in CTIS.
Major undertaking
Panelists agreed that overhauling the way that clinical trials are reported in the EU has been a major undertaking.
“This is a brand-new, massive system covering all aspects of clinical trials,” said Bertrand Fournier, the director of regulatory affairs for Shionogi. “There are little glitches and little bugs here and there.”
Fournier said his company is waiting until some of the problems are fixed to submit an application.
Member State divergence
A major problem cited by panelists is that Member States are diverging and requiring additional documents that are not specified in the CTR.
“We have heard multiple reports of Member States requiring documents that are not initially foreseen in the clinical trials regulation so this is something that we would like to flag to the authorities and the European Commission,” said Fournier.
For example, some Member States are requesting information on validation, which is above and beyond what is required in the CTR, said Shaila Choi, director of regulatory affairs for Seagen. The company has filed a submission through the CTIS and plans to file another soon.
“When it came to validation questions, we had some country-specific requests, which goes against the idea of the whole clinical trials regulation, and we pushed back against those requests,” Choi said. “My advice to those who are planning to submit is don’t be afraid to quote the question and answer document if the information you are asked for is contrary to the regulations.”
Choi also noted that the system does not flag any missing information, so the company must check the application frequently for any updates.
Forum suggested to resolve issues
Fournier suggested the EU establish a forum for resolving issues and disagreements with Member States on CTIS implementation. “Such a forum providing feedback would be a win-win approach.” He said that while such a forum is in effect at the EU level, there is no entity for resolving disputes with Member States.
Selma Stockner of Zealand Pharma agreed. “I wholly agree with Bertrand…apart from getting the last of the 90% of the trials running through the system and to ensure the system can cope with that, it is important to have a strong forum for alignment between the Member States. This would help, and it would help align with Europe.”
Working on CTIS is a priority
In the meantime, Anabela Marcal, head of compliance and the inspection department at EMA, said that the EMA is working on some of the technical glitches with the system and that these problems will be resolved by the effective date.
She added that the EU would not grant an extension for complying with CTIS, and that registration will be mandatory after 23 January 2023.
RAPS Convergence


© 2023 Regulatory Affairs Professionals Society.

Tags: clinical, CTIS, EMA, trials

Discover more of what matters to you