Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
EMA Updates HRT Product Information to Clarify Ovarian Cancer Risk
EMA has updated the product information for hormone-replacement therapy (HRT). The changes follow a review by the Pharmacovigilance Risk Assessment Committee (PRAC) late last year, which concluded EMA should strengthen the warning about the link between HRT and ovarian cancer.
In the previous product information, ovarian cancer was described as a slight risk for people who took HRT for five to 10 years. However, since EMA drafted that version, a meta-analysis published in The Lancet has found shorter-term use of HRT is also associated with a slightly increased risk of the development of ovarian cancer. The publication of data against the hypothesis that only long-term use of HRT puts people at risk of ovarian cancer prompted PRAC and EMA to reassess their position.
Whereas the old text read “long-term (at least 5-10 years) use of oestrogen-only HRT products has been associated with a slightly increased risk of ovarian cancer,” the revised document states: “Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only or combined oestrogen-progestagen HRT, which becomes apparent within 5 years of use and diminishes over time after stopping.”
EMA has also revised a section detailing the number of extra cases of ovarian cancer it would expect to see among people receiving HRT. The regulator now advises that two in every 2,000 women aged 50 to 54 years old who are not taking HRT will develop ovarian cancer over a five-year period. Among women who have been taking HRT for five years, the rate increases to three in 2,000, one extra case per 2,000 people.
Industry Called to EMA Meeting on Implementation of ISO Standard for ICSRs
EMA is asking representatives of software vendors, service providers and biopharma companies to attend a meeting on the implementation of a standard for individual case safety reports (ICSRs). The one-day event will discuss the technical implications of adopting the International Organization for Standardization’s (ISO) stance on ICSRs.
Officials at EMA began preparing the industry for the implementation of the ISO ICSR standard one year ago, when they published a 100-page document covering the technical details of the incoming system. Now, with the ISO ICSR standard due to come into force on 1 July, EMA is preparing to hold a workshop at which it will discuss technical aspects of implementing HL7 XML messages, while also hearing the experiences of organizations that have started adopting the ISO standard.
“The Agency as part of the EU Regulatory Network wishes to provide a forum where industry and regulators are able to openly discuss the technical aspects of the implementation of the ISO ICSR standards in Europe,” EMA wrote in its call for expressions of interest in attending the workshop. “It is foreseen that this workshop would include participation from software vendors and service providers as well as implementers of pharmacovigilance systems.”
EMA Invite, Meeting Summary
UK Polls Public Ahead of Overhaul of Health Data Sharing Website
The United Kingdom is surveying users of its Clinical Practice Research Datalink (CPRD) health data sharing service ahead of a planned redevelopment of the website. Officials want to understand how people are using the existing website before committing fully to the redevelopment strategy.
CPRD is a governmental, nonprofit offering that provides researchers with access to anonymized data from the UK National Health Service. The resource is the cornerstone of many projects to reveal details about the provision of healthcare in the UK. Before redeveloping the website that facilitates these research initiatives, CPRD is surveying users. The survey asks users how often they visit the CPRD website, what they go there for, how often they can achieve their goals and how long it takes.
Officials are also seeking feedback on how users see the website by asking them to select the most appropriate descriptive words from a list that ranges from “clunky” and “confusing” to “clean” and “fresh.” The survey digs deeper into these feelings by asking users to rate the attractiveness, ease of use, accuracy and other characteristics of the website on a scale of one to four. The website redevelopment team will use the data to shape its activities.
Denmark Names Parexel Exec as Head of Medicines Agency
The Danish Medicines Agency (DKMA) has named Thomas Senderovitz as its director. Senderovitz, a physician whose résumé includes spells at Parexel and UCB, is the first person to take charge of the regulator since it was re-established as an independent agency in October.
DKMA was housed within the Danish Health and Medicines Authority from 2012 to 2015, but struck out on its own again late last year. The Danish Ministry of Health has given Senderovitz the task of guiding the newly independent organization. Senderovitz started out his career training to become a medical doctor at the University of Copenhagen, only to sidestep into the pharma industry in 1998. Since then, Senderovitz has held drug development posts at Parexel, UCB and Grünenthal.
Senderovitz will take up the position at the start of April, but already has a clear idea of what he aims to achieve during his spell in charge. “I am very pleased to have the opportunity to head the newly established agency, because it provides unique opportunities to start afresh,” he said. “We will strengthen our interaction with the sector, for example by reducing assessment times and setting a higher standard for scientific advice.” Senderovitz also wants to increase international cooperation.
Medicoindustrien, the Danish medical device industry association, has welcomed the appointment, describing Senderovitz as a very qualified candidate. The trade group said Senderovitz’s background fits with the desire of the pharmaceutical industry to have a leader who has a medical education and experience in the industry. Possession of insights into the pharmaceutical sector and the relationship with the European Medicines Agency (EMA) were viewed as prerequisites by some observers.
While Senderovitz fits these criteria, Medicoindustrien mentioned some issues he is likely to face. The trade group highlighted a lack of resources as a long-running problem that will test his skills. Medicoindustrien sees the resource shortage as being a particular problem for the medical device sector, an industry with which Senderovitz is less familiar than drug development. The trade group predicts these issues will create some of the bigger challenges faced by Senderovitz.
Press Release, Medicoindustrien Statement (Danish)
France’s Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) has shared its plan to strengthen oversight of drugs and medical devices in 2016. The plan includes a program to monitor the risks and benefits of products, 650 inspections, 10% of which will be unannounced, and moves to tighten ANSM’s ties to groups of patients and health professionals. ANSM Notice (French)
A survey of European Notified Bodies (NBs) has identified a slump in CE Mark certifications in recent years. In 2010, almost 7,000 new CE Marks were issued to medical devices. Since then, the number of certifications has dropped. Last year, NBs reported 4,543 certifications. A sharp increase in the number of withdrawals was identified over the same period. Emergo Group
Medtronic has received a CE Mark
for its IN.PACT Admiral drug eluting balloon. Press Release