European Regulatory Roundup: EU Device Regulations Come Into Force Swissmedic Clarifies Pharmacovigilance Process (1 June 2017)

Welcome to our European Regulatory Roundup, our weekly overview of the top EU Regulatory news.

EU Medical Device Regulations Come Into Force, Starting Multi-Year Transition Period

The European Union medical device and in vitro diagnostic (IVD) regulations have come into force. The passing of the date marks the start of the phased, multi-year introductions of requirements set out in the two documents.

In the immediate term, the entry of the long-gestating regulations into force will have little effect on the industry or the organizations that regulate it. Instead, the event is the starting point for the staggered implementation of sets of requirements that will reshape how the medical device and IVD sectors are regulated in the EU. In the case of the medical device regulations, the requirements will come into force between now and 2020. The transition phase for the IVD regulations lasts two years longer.

While the dates for full implementation of the documents are fairly distant, the regulations feature nearer-term milestones. The first deadline is 26 November. By then, the European Commission must "draw up a list of codes and corresponding types of devices" to specify the scope of notified bodies.

26 November is also the date on which certain articles of the regulations start to come into force. For example, the article covering the establishment of a Medical Device Coordination Group is set to come into force in November.

Beyond that, the cooperation article of both regulations is set to come into force in 2018. This article calls on member states to cooperate with each other and the commission, while also participating in international initiatives. The goal is to ensure the regulations are applied uniformly and encourage authorities to work together.

Device Regulations, IVD Regulations

Swissmedic Clarifies Pharmacovigilance Process to Avoid Extra Administrative Work

The Swiss Agency for Therapeutic Products (Swissmedic) has told pharmaceutical companies to stop sending it individual case reports. Currently, reports are being sent to both Switzerland's regional pharmacovigilance centers and Swissmedic, resulting in a "considerable amount of extra administrative work for all involved."

Swissmedic wants to eliminate this additional work. To do so, the agency has told companies not to send it individual case reports. Doctors and patients send these reports of adverse events to regional centers that, in turn, process them and forward them to the Swissmedic national pharmacovigilance center. Swissmedic then evaluates the reports and forwards them to the affected MAHs.

Problems are arising because companies are sending reports directly to Swissmedic. This creates duplicates. Swissmedic said the burden created by this double reporting is considerable. As such, it wants companies to follow the proper channels.

The agency used its alert about avoiding double reporting to bring up two other issues. Swissmedic told pharmaceutical companies the reports it forwards to them have already been evaluated. If a company disagrees with the evaluation, it should not send the report to Swissmedic. The agency will ask companies if it wants them to assess a report or situation. Companies that have relevant follow-up information should send a new report that refers to the original report.

Swissmedic included the clarifications in its vigilance newsletter. The report also discussed the use of big data in pharmacovigilance. Swissmedic said it is "actively participating in collaboration initiatives to build up and take advantage of big data analysis as soon as such pharmacovigilance systems have been established."

Swissmedic Notice

EMA Puts Brexit Preparation on the Agenda of First Bilateral EuropaBio Meeting

The European Medicines Agency (EMA) is set to discuss preparations for Brexit at its first bilateral meeting with the trade group EuropaBio. EMA's decision to put the topic on the agenda continues its push to raise awareness about the implications of Brexit for the drug companies it regulates.

EuropaBio and EMA are holding the meeting, the first of its kind between the organizations, to talk about topics of common interest. The United Kingdom's withdrawal from the European Union falls into this category, securing it a spot on the agenda alongside less topical subjects including the use of big data by industry and "new paradigms" in drug development. EuropaBio and EMA are devoting 30 minutes of the half-day schedule to Brexit.

EMA laid out how it sees Brexit affecting marketing authorization holders (MAHs) in two texts last month. The first text, which EMA released with the European Commission, told drug companies "to prepare and proactively screen authorizations they hold for the need for any changes." EMA also alerted MAHs to the need for them be established and perform certain processes in the EU or European Economic Area. The UK will cease to be such a location after Brexit.

This week, EMA followed up on that text with the first in a series of Brexit-related question and answer documents. The Q&A explains that marketing authorizations and orphan drug designations currently held by UK-based companies must be transferred to entities within the EEA after Brexit. The location batch release takes place and residence of the qualified person for pharmacovigilance must move to the EEA, too.

Other tasks can stay in the UK, but will become subject to an additional layer of regulation. From the perspective of EMA, the UK will become a third country after Brexit. This means UK producers of active pharmaceutical ingredients will need to obtain a written confirmation from their local regulator to import products into the EU. UK manufacturers of finished products must specify an authorized importer and submit a variation.

Meeting Agenda

Dutch MEB Starts Technically Validating Submissions, Will Decline to Process bad Filings

The Medicines Evaluation Board (MEB) of the Netherlands has started the technical validation of electronic submissions. Dossiers that are classed as technically invalid or fail to follow the prescribed format will not be processed by the Dutch regulatory agency.

MEB introduced the validation step on 1 June. The validation will follow harmonized European standards. MEB is breaking the process down into two parts. First, MEB will manually check whether the cover letter meets the required standards. Once that step is complete, MEB will use EURSvalidator to validate the submission.

EURSvalidator is a technology used by regulatory agencies including EMA to check whether filings comply with either the electronic common technical document (eCTD) standard or non eCTD electronic submission (NeeS).

MEB will send the outcome of the validation process and accompanying technical report to the case contact. The agency will reject filings that fail the validation test. MEB will also reject filings that are password protected or have a "serious defect." Such defects include the presence of a virus or the use of an unreadable CD. MEB will tell the case contact of rejections for these reasons via phone or email.

MEB Notice, More

Other News:

The Health Products Regulatory Agency (HPRA) of Ireland has provided an update on the progress of its innovation office. Since setting up the office late last year, HPRA has provided support to more than 20 organizations and individuals. More than 40% of queries received to date by the office relate to medical devices. One-third were about drugs. HPRA Statement

Roche has started investigating the safety of its multiple sclerosis drug Ocrevus after a patient in Germany developed a brain infection. The patient developed progressive multifocal leukoencephalopathy, the same infection that affects some people who take Biogen's rival drug Tysabri. The patient had previously taken Biogen's drug. Reuters