EU Regulatory Roundup: EMA, Running Two Years Behind Schedule, Gears up for Clinical Trial Portal Audit

RoundupsRoundups | 20 June 2019 |  By 

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
EMA, Running Two Years Behind Schedule, Gears up for Clinical Trial Portal Audit
The European Medicines Agency (EMA) has begun preparing its Clinical Trials Information System (CTIS) for audit. EMA performed testing and bug fixing of the single entry point for clinical trial information earlier in the year, positioning it to now enter “a phase of agile, iterative delivery” this month.
CTIS, formerly known as the clinical trial portal and database, is central to EMA’s efforts to harmonize assessment processes in line with the incoming Clinical Trial Regulation. All clinical trial information will enter EMA’s systems via CTIS, which is designed to enable sponsors and regulators to securely compile and review data and other materials involved in the regulation of research in humans.
Work on the project has now reached the point that EMA is preparing for an audit of the system. To support development, EMA is now directly engaging member states and stakeholders in the process through nominated “product owners.” EMA thinks this will ensure their views are factored in.
“This means that business expert representatives have an enhanced and continuous opportunity to review, select and verify functionalities,” EMA wrote in an update on the progress of the project.
EMA added that it and member states are “fully committed” to delivering the project and making it a success, but the path to this point has been far more troubled than expected. The original delivery time frame approved late in 2015 set EMA the goal of having a version ready for audit in July 2017. If EMA had hit the original timeline, it would now be working on further upgrades and enhancements. Instead, EMA is yet to put the portal through the audit.
The timeline for delivery slipped in the face of “technical difficulties.” EMA and its developer reset expectations in March 2018, at which point the goal was to have a version ready for audit early this year. The revised timeline and strategy featured “increased contingency” and “improved project management, development and testing processes and resources” to prevent further delays. Yet, six months into the year, EMA is yet to start the audit.
EMA made no comment about the effect of the delay on the application of the regulation. The rules were due to come into effect in October 2018, but estimates slipped to the middle of 2020 when EMA published the revised timeline for portal development last year.
EMA Update
EMA Puts out €10M Security Tender to Protect Amsterdam Office
EMA is trying to enter into a contract with a security service supplier ahead of the move to its new permanent home in the Netherlands early next year. The €10 million ($11 million) contract will cover activities including the deployment of guards and technical surveillance countermeasures.
With EMA aiming to employ around 900 people at its new Amsterdam office and welcome up to 350 delegates a day, the headquarters will have extensive security requirements, particularly given the sensitive and sometimes controversial nature of the agency’s work. To ensure the protection of the people and information at the site, EMA has put out a contract for a security tender.
The tender covers a diverse range of activities, from the X-ray scanning of luggage through to efforts to “identify hostile radio transmissions and phone bugs.” Other tasks covered by the contract include the provision of lanyards, nine-person security teams and mobile device detectors, locators and blockers.
EMA wants a single security supplier to take on all of these tasks. The winning bidder will land a two-year contract that may be renewed for two additional one-year periods.
The agency released the tender days after putting out a €2.1 million request for reception and switchboard management services. EMA is accepting offers for both contracts for around one month.
Security Tender, Switchboard Tender
Germany Maintains Fecal Transplant Policy Amid Safety Concerns in US
Germany’s Federal Institute for Drugs and Medical Devices (BfArM) has maintained its policy on fecal microbiota for transplantation (FMT) amid concerns about the safety of the procedure in the United States.
The US Food and Drug Administration (FDA) responded to cases of bacterial infections with multidrug resistant organisms (MDROs) stemming from the use of FMT by requiring additional screening and testing of donors and the stools they provide. FDA thinks the additional protections are needed to cut the risk of further MDRO infections. One of the patients died.
BfArM responded to events across the Atlantic by restating its position on FMT. Believing that the existing safety requirements for applications to run FMT clinical trials in Germany are high, BfArM opted against following FDA by imposing additional restrictions on the sector.
That decision reflects the level of scrutiny already required in Germany. BfArM expects sponsors of FMT clinical trials to test stool and blood samples from potential fecal donors for a range of bacteria, fungi, parasites and viruses, including the type of extended-spectrum beta-lactamase-producing bacteria responsible for the adverse events in the US.
A positive test for a pathogen is one of many stool donor exclusion criteria used in Germany. BfArM also expects sponsors to exclude potential donors if they have passed a loose stool in the past four weeks or have recently traveled to countries at risk of infectious bowel disease.
BfArM Notice (German), Regulatory Focus
Finnish Regulator Talks up Prospect of Pharmacy-Level Biosimilar Substitution
The Finnish Medicines Agency (Fimea) has talked up the prospect of permitting pharmacists to swap biosimilars for their reference products. Fimea concluded that automatic substitution is “possible” after gathering the views of patient organizations and other affected groups.
Finland’s move toward automatic substitution will happen gradually. Fimea thinks the first step is to run a pilot “in operating environments where the cooperation between pharmacies and other health care services is as seamless as possible.” The agency wants to safeguard safety without unnecessarily burdening parties involved in the substitution.
Even if the idea advances past the pilot stage, substitution will remain subject to conditions. Fimea  will determine the clinical and practical interchangeability of biosimilars and reference products, for example by assessing differences between administration devices.
Biosimilars deemed interchangeable would become eligible for substitution by pharmacists, a group Fimea wants to support with “new tools and systems” to ensure safety. Prescribers would have the option to forbid substitution on medical or therapeutic grounds.   
While the conditions would constrain biosimilar uptake to an extent, Fimea still sees considerable opportunities to save Finland money by switching patients to off-patent biologics. In 2017, eight of the top 10 best selling drugs in Finland were biologics, recording total sales of €256 million ($287 million).
Biosimilar versions of some of these biologics are cleared for use in Finland, but many physicians continue to start new patients on more expensive reference products. Pharmacy-level substitution could make biosimilars the preferred option for more patients.
Fimea Notice
Other News:
Fimea has opened up access to a database designed to help healthcare professionals choose drugs for use in patients aged 75 years and older. The action will make the contents of Meds75+ “more readily usable as part of different databases,” Fimea said. Fimea Notice
M & A Pharmachem is recalling two batches of paracetamol tablets from the UK after fungal contamination was found in some packages. MHRA Notice


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