Euro Roundup: EMA keeps deadline for CTIS switch, says it can fix ‘blocking bugs’ in time

Use of the Clinical Trials Information System (CTIS) will become mandatory for new applications at the end of the month. EMA retained the deadline after determining that it can resolve the final “blocking bugs” by the go-live date.
 
When EMA’s management board met last month, the agency outlined a plan to ensure that it fixed all technical issues affecting core CTIS processes in time for mandatory use of the system. The agency  has resolved “more than 80% of the blocking issues and related workarounds” and is on track to fix the remaining issues by next week, according to its latest update.
 
EMA released the update alongside the results of a consultation demonstrating the problems CTIS users have faced during the one-year transition period. The survey ran from July to September 2022; EMA noted  that many of the issues reported have been fixed; therefore, the feedback does not necessarily reflect the current status of CTIS.
 
Asked to list the blocking issues they faced, most respondents most commonly cited issues the use of CTIS and the lack of harmonization within the EU, according to an EMA summary.
 
“Positive feedback was received concerning the ‘one-stop shop’ offered by CTIS, and the responsiveness of the helpdesk, while others pointed to difficulties in using CTIS and system stability issues,” the summary notes. “Numerous technical problems are reported, such as issues when answering to the request for information, no access to uploaded documents, deferral request disappearing after submission, incorrect timetable calculation, inability to update application.”
 
Sponsors sought assurance that CTIS would always preserve the confidentiality of commercial information and requested new features “such as adaptation to handle platform trials and complex trial design.” EMA also received requests for features to indicate missing information when making applications, to enable the export of the list of submitted documents and for an email notification system.
 
EMA Notice, Survey Responses
 
EMA drug shortage group calls for supply transparency
 
The EU Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) has stressed the importance of being transparent about drug shortages in a notice outlining its response to disruption to the supply of antibiotics.
 
MSSG brings together the European Medicines Agency (EMA), the European Commission and the Heads of Medicines Agencies to coordinate urgent EU actions to manage issues related to the supply, quality, safety and efficacy of medicines. The steering group began monitoring the disruption of the antibiotic supply chain in November.
 
The shortages reflect both a surge in respiratory infections, which has increased demand for antibiotics, especially as pediatric formulations of amoxicillin, and manufacturing delays and capacity issues that have slowed supply in most member states. Officials have taken actions to try to ensure patients can access appropriate treatment.
 
“National Competent Authorities, as encouraged by the MSSG, are making use of the regulatory flexibilities available, such as allowing the exceptional supply of certain medicines or presentations that may not be authorized in a particular member state or granting full or partial exemptions to certain labeling and packaging requirements to ensure that patients can receive appropriate treatment. In addition, MSSG supports temporary national measures such as unit dose dispensing and compounding,” MSSG wrote.
 
The three organizations that make up the steering group are “cooperating closely to investigate whether additional measures could be undertaken to mitigate the impact of these shortages.” MSSG expects the situation to improve in the near term based on the information it is receiving from companies and other stakeholders.
 
MSSG stressed “the importance of transparency in relation to shortages” and highlighted “the need for all stakeholders to communicate in an objective and responsible way to avoid any undue public concern.”
 
EMA Notice
 
UK to create regulatory framework for point-of-care drug production
 
The Medicines and Healthcare products Regulatory Agency (MHRA) is pushing ahead with plans to make a regulatory framework for the production of drugs at the point of care after reviewing feedback from a public consultation. MHRA said the framework will be the first of its kind globally.
 
Current regulatory frameworks are designed around what happens during centralized production. However, some medicines, such as molecules with very short shelf lives, are better suited to decentralized production.
 
A public consultation run by MHRA in 2021 showed a demand for a dedicated framework. Almost all (94%) of organizations that responded to the survey agreed point-of-care production is sufficiently different to current factory-based manufacture that a new framework is required.
 
Based on the feedback, the government plans to propose legislation this year and MHRA will create guidance to accompany the framework. The government outlined its aims for the framework in its response to the feedback.


“The new framework will outline regulatory control measures to assure a focus on product safety and quality across the lifecycle of each and every product. There will be specific criteria to be met at application for a POC manufacturing authorisation, during clinical trials, at assessment for marketing authorisation, at inspection and also through pharmacovigilance when the product is in routine manufacture,” the government wrote.
 
Press Release, Consultation Response
 
Pharma industry welcomes MHRA’s ‘pragmatic’ decision to factor EU approvals into UK filings
 
The Association of the British Pharmaceutical Industry (ABPI) has welcomed MHRA’s updated plans for its post-Brexit system for approving medicinal products in the UK.
 
Last year, MHRA extended the European Commission Decision Reliance Procedure (ECDRP) until the end of 2023 to allow companies to continue to use positive opinions in the EU to support filings for approval in the UK. Companies that receive a Committee for Medicinal Products for Human Use (CHMP) positive opinion before 31 December can seek approval in the UK via the ECDRP.
 
Now, MHRA has said that from 1 January 2024 companies can apply for UK approval through its “new international recognition framework, which will have regard to decisions already made by the European Medicines Agency and certain other regulators.” Applications with a CHMP positive opinion from after 31 December 2023 will be eligible. MHRA also plans to rely on the decisions of additional regulators.
 
David Watson, executive director, patient access at ABPI, welcomed the plan. “MHRA’s pragmatic decision regarding GB marketing authorization applications is an important one for our industry. Pharmaceutical companies now have the clarity needed to inform their regulatory decisions for the year,” Watson said.
 
MHRA Notice, ABPI Response
 
Other news:
 
EFPIA has started an initiative to give patients cross-border access to clinical trials across the EU. Working with the European Forum for Good Clinical Practice, the trade group has set up a consortium to develop recommendations for making it easier for patients to cross borders to participate in clinical trials. Press Release