Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Ireland Hires IVD, Medical Device Staff Ahead of EU Legislative Changes
Ireland’s Health Products Regulatory Agency (HPRA) has begun recruiting for medical device and in vitro
diagnostic (IVD) positions ahead of the implementation of Europe-wide legislative changes.
HPRA released advertisements for two positions this week, both of which refer to the incoming European Union legislation and its effects on regulatory activities in Ireland. The ads cover the recruitment of a medical devices regulatory and policy assessor and an IVD operations manager. The staff will work at HPRA’s regulatory and policy and assessment and surveillance departments, respectively.
Ireland’s regulator provided context for the appointments in the ad to recruit the IVD operations manager
“The HPRA is undergoing change and development initiatives in order to optimize our medical device activities and implement the new European legislation on medical devices,” the agency wrote in the ad.
Ireland has until 2022 to prepare for the IVD rules, but the timeline for medical device legislation is far tighter. With the medical device rules set to come into force in 2020, HPRA wants to hire a regulatory and policy assessor to help with tasks including the “planning, coordination and development of the communication strategy on implementation” of the legislation.
HPRA also expects the new hire to work with colleagues at the agency, its legal team and the Irish Department of Health to “ensure national legislation on medical devices is aligned and supports the new EU regulations.”
Those objectives reflect the current areas of focus at HPRA’s communications and policy team. HPRA puts the timely and effective implementation and maintenance of EU device and IVD legislation high on the team’s list of current objectives.
That objective is echoed in the job description for the new IVD hire, whose responsibilities will include ensuring “that the assessment of regulatory compliance and application of the medical device legislation is carried out effectively and efficiently across the HPRA’s medical device regulatory activities.”
HPRA is offering three-year fixed term contracts at a salary of €61,641 ($69,035) per annum for both positions.
Dutch MEB Changes Policy on Patented Indications After Legal Ruling
The Medicines Evaluation Board (MEB) has detailed its response to a legal ruling against its policy of publishing certain information about patented products online.
MEB’s website used to list indications covered by patents in its information about generic medicines. That policy was challenged by Pfizer’s Warner-Lambert, which argued that it could lead to generics being used in diseases covered by patents protecting the originator molecule. The European Court of Justice sided with Warner-Lambert earlier this year, forcing MEB to change its policy.
The Dutch regulator acknowledged the ruling and sketched out its response in March. Now, MEB has provided more information in a second statement and a webpage dedicated to the topic.
MEB’s webpage states that the marketing authorization holder (MAH) of a generic drug can request that patented indications are excluded from documents including the package leaflet and the summary of product characteristics (SmPC). Responsibility for requesting the removal of the information falls on the MAH.
The policy adopted by MEB places certain restrictions on the removal of information. MEB will only allow the removal of information about the patented indication from three sections of the SmPC and the corresponding parts of the package leaflet. All safety information must be retained, regardless of whether it relates to the patented indication.
Leaflets that lack information on patented indications will feature a line about the fact that the active ingredient is used in the treatment of diseases not mentioned in the document. Upon the loss of patent protection, MAHs can get that line removed and insert information about new indications by following an MEB procedure on the revision of materials.
Swissmedic Reports 200% Increase in Seizures of Illegal Drug Shipments
The Swiss Agency for Therapeutic Products (Swissmedic) has reported a 200% increase in seizures of shipments of illegal medicines. Swissmedic attributed the jump to “a new, simplified procedure” and closer cooperation between Swiss agencies.
In 2018, the Swiss Federal Customs Administration (FCA) seized 3,203 shipments of illegally imported medicinal products, up from 1,060 shipments the previous year. Erectile dysfunction drugs topped the list of seized drugs in both years, trailed by psychotropic agents, sleeping tablets, tranquilizers and other medicines associated with abuse and dependence.
As in 2017, India was the main source of illegal shipments into Switzerland last year, accounting for 42% of all seizures. The proportion of shipments originating in eastern Europe, primarily Hungary and Poland, increased year on year, resulting in the region becoming the second most common source of seized shipments. Eastern Europe overtook Singapore and other ex-India Asian countries.
Last year marked the first time Swissmedic and FCA trialled a simplified procedure. The agencies initially tested the new approach as part of their efforts to stop erectile dysfunction drugs entering Switzerland illegally, resulting in these medicines making up a higher proportion of seizures — 89% — than in previous years.
Having validated the simplified procedure, Swissmedic and FCA are using it in the policing of other classes of medicine this year, suggesting that the number of seizures could increase again in 2019.
France’s ANSM Addresses Cell and Gene Therapies in Revisions to GMP Guide
France has revised its guide to good manufacturing practices (GMPs). The document now features a section on the manufacturing of advanced therapy medicinal products (ATMPs).
When the National Agency for Medicines and Health Products Safety (ANSM) first published its GMP guide in 2015, the text featured three sections that covered the rules for drugs for human use, active substances and documents involved in regulatory-compliant production. Now, ANSM has added a fourth section that details how GMPs apply to cell and gene therapies and other ATMPs.
The new section is around 100 pages long and covers topics including the risk-based approach to the regulatory standards of ATMP production, staff training, seed lots and aseptic manufacturing.
ANSM’s position on the application of GMPs to ATMPs will be familiar to anyone who knows the document the European Commission published on the topic in 2017. Both documents cover exactly the same ground.
French authorities added the section on ATMPs to the guide alongside other changes affecting the section on active ingredients. ANSM last updated the document late in 2016.
The European Medicines Agency
(EMA) has begun a social media campaign to raise awareness of the work of the European regulatory network. The campaign will share infographics on LinkedIn and Twitter to inform the public of how EMA and its collaborators in member states work together to monitor the safety of medicines used in Europe and raise standards. EMA Statement
is withdrawing transvaginal mesh products used in the repair of pelvic organ prolapse from the European market. The medtech company is still allowed to sell the products in Europe but responded to the ban on sales in the United States with a worldwide withdrawal. The action means treatment centers in countries, including Denmark, lack access to mesh. Safety Notice
, DKMA Statement
has published its annual report for 2018. The document details EMA’s activities last year, including how it sought to mitigate the impact of Brexit. EMA Report