Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
UK Centrally Authorized Product Portfolio Reallocated Ahead of Brexit
The European Medicines Agency (EMA) has redistributed the UK’s portfolio of centrally authorized products. EMA shared the 370 products currently handled by UK agencies to rapporteurs and co-rapporteurs in other countries in anticipation of Brexit.
The action affects approved human and veterinary medicines. Currently, staff at the Medicines and Healthcare products Regulatory Agency (MHRA) and Veterinary Medicines Directorate (VMD) have leading roles in the ongoing evaluations and regulatory processes for hundreds of products. However, once the UK leaves the European Union, MHRA and VMD staff will no longer be eligible for this task.
With the UK scheduled to leave the EU in under 12 months, EMA has reassigned oversight of MHRA and VMD’s products to the other 27 member states, plus Iceland and Norway. The new rapporteurs and co-rapporteurs will take full responsibility for the products on 30 March. Before then, EMA will work to transfer knowledge of the medicines from the UK to the new overseers.
EMA has sought to reassign the UK’s portfolio in a way that considers the capabilities of member states, the burden associated with each medicine and the desire among its more recent members to take responsibility for generic and hybrid products. In many cases, the co-rapporteur will step up to the rapporteur role, but EMA inserted clauses into its methodology to ensure work is spread broadly across the regulatory network.
, EMA Report
EMA Seeks Feedback on Extrapolation of Antibiotic Data to Pediatric Populations
EMA has released draft guidance on the extrapolation of antibiotic data to pediatric populations for consultation. The addendum sets out when and how sponsors can file for approval of an antibiotic in children on the basis of data generated in adults.
Officials at EMA are proposing to allow sponsors to extrapolate efficacy data across age ranges most of the time. The exceptions are situations in which efficacy studies cannot be performed in adults or there are doubts about whether data generated in adults is applicable to children. EMA lists impetigo, infected atopic dermatitis and acute otitis media as indications in which pediatric efficacy studies may be necessary.
The safety considerations are different, but also leave considerable scope for sponsors to extrapolate data. EMA expects sponsors to run safety studies when data generated in adults or preclinical tests reveal concerns of particular relevance to the use of the antibiotic in children.
Antibiotics that are free from such safety concerns and the aforementioned efficacy doubts can come to market in children on the basis of adult data and pediatric pharmacokinetic studies. EMA thinks most antibiotics will fall into this category. The agency expects sponsors that take this abbreviated path to approval to consider and justify the timing of their pediatric studies in relation to the availability of data in adults.
EMA is accepting feedback on the draft until the end of October.
Meeting Minutes Reveal EMA Board’s ‘Complete Surprise’ at Aspects of Dutch Bid
Meeting minutes shared by EMA have revealed members of the agency’s board expressed “complete surprise” when financial aspects of Amsterdam’s hosting bid came to light. The shock centered on the revelation that Amsterdam had excluded the fitting out and furnishing of the EMA headquarters from the costs cited in its bid, resulting on the outlay coming in far higher than the board expected.
The minutes, which were released this week, cover an EMA board meeting held in early February, and Dutch officials have since revised the costs to bring them more in line with expectations. While that means the concerns raised in the minutes are now out of date, the document still sheds light on the teething problems EMA has faced in trying to arrange its move to Amsterdam.
Amsterdam, like other cities, provided European officials with projected costs associated with its hosting of EMA as part of its bid. Those figures were submitted last summer. After Amsterdam was picked to host the agency, the city provided a revised offer with different figures. Notably, the cost of fitting out the building came in well above expectations
“Concerning the difference by €50 million ($62 million) equivalent to €2.5 million a year for fitting out costs highlighted by EMA, the Dutch government provided an offer only for a ‘hull’ building, as the requirements set out by EMA and by the Council were not detailed enough to do all the necessary interior design,” EMA wrote in its meeting minutes.
EMA board members expressed “complete surprise” that the construction costs were excluded from the original bid. That was one of several issues brought up at the meeting. The EMA board was similarly shocked to learn “that the cost of maintenance was increased” and “that an increase in overall costs of 35 to 44% could have taken place in just two months.” A Dutch defense centered on the rising cost of real estate in Amsterdam was dismissed on the grounds EMA’s relocation is behind the trend.
The meeting ended with the board asking the Dutch government to bring its offer in line with that included in the original bid. Weeks later, Dutch officials provided a revised offer that was welcomed by the board. The revised offer brought the cost per square meter down from €433 to €320.
, Second Meeting
EMA Revises Public Hearing Guidance Ahead of Second Meeting
EMA has revised guidance for participants in public hearings. The update incorporates lessons learned at the first public hearing last year to better inform people interested in attending the upcoming second meeting.
Most of the guidance is unchanged. EMA has added one new question and made relatively minor revisions to some of the existing sections of the text.
The new question addresses what participants should do if approached by a journalist who wants to talk to them at the hearing. EMA’s guidance states, “It is perfectly fine to speak to journalists” but recommends discussions take place outside the building. That position is based on concerns that the presence of the press will affect EMA’s work, security arrangements and — if cameras are used — the privacy of its staff and visitors to the building.
Other changes included the revision of the time allotted to each speaker — from between five and 10 minutes to around seven minutes — and the adoption of a different tone in some areas.
For example, the original guidance warned that it may not be possible to accommodate everyone who wants to attend a public hearing. The revised guidance drops this statement in favor of a more welcoming comment.
“We are keen to have wide representation from right across the EU. We will do our best to accommodate everybody, taking into account the space and time available to us,” the guidance now states.
EMA made the revisions to the guidance in anticipation of its second public hearing. The discussion of the safety of the antibiotics quinolones and fluoroquinolones will take place on 13 June. To help participants prepare for the hearing, EMA has also released a list of questions it wants attendees to focus on.
, Hearing Questions
The Danish Medicines Agency
has issued a warning about acupuncture needles falsely labeled with CE marks. DKMA Notice