European Regulatory Roundup: MEPs Plan Amsterdam Trip as Parliament Criticizes EMA Move

Regulatory NewsRegulatory News | 15 February 2018 |  By 

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
MEPs Plan Amsterdam Fact-Finding Trip as Parliament Steps up Criticism of EMA Move
European politicians are set to visit Amsterdam to check up on the status of the medicine agency’s relocation to the city. The members of the European Parliament (MEPs) see the visit as a chance to confirm if the move is proceeding “as planned and with no interruption” before finalizing proposals to legislation sealing the relocation.
Giovanni La Via, the person leading the Committee on Environment, Public Health and Food Safety’s (ENVI) scrutiny of the legislation, is heading up the delegation to Amsterdam. While in the city, La Via and other members of ENVI will visit the temporary home of the European Medicines Agency (EMA) and its permanent base. The goal is to assess the double relocation the agency is planning to perform next year.
The delegation will use the impression they gather during the 22 February visit to inform their input to legislation to formally confirm Amsterdam as the new home of EMA. ENVI has already begun its review of the legislation. La Via detailed his position in a draft report last month, in which the Italian politician criticized how the European Parliament was marginalized in the process of choosing a new headquarters for EMA.
Other ENVI members have now picked up and reinforced the same theme in draft amendments to the text. The proposals call for the legislation to state the process was deplorable. An earlier version called the process regrettable.
The tone of the amendments divides along national lines. Dutch MEPs are seeking to cut a section on regrets about the way Amsterdam was chosen and insert a section detailing the popularity of the city among EMA staff. In contrast, politicians from Italy, which narrowly lost the race to host EMA, have used the legislative process to mount a campaign to get the decision overturned.
Two Italian MEPs are pushing for an amendment that calls for the choice of city to be “reconsidered in the light of the delays occurring in Amsterdam, which are undermining the right to health of our citizens.” A third faction is complaining that the Council failed to take the opportunity to give newer members of the European Union another agency.
Most MEP amendments never make an impact on legislation, but in this case they form part of a wider resistance to EMA’s move to Amsterdam. This week, the mayor of Milan revealed he has ordered his legal team to ask the European Commission to release the Dutch dossier, specifically to see whether it referred to the need for EMA to move into a temporary building. With Italy holding elections early next month, the comments could be empty electioneering, though.
ENVI Notice, Draft Amendments, Sala Post
EMA Floats Changes to Cardiovascular Risk Section of Diabetes Guideline
EMA is seeking feedback on planned changes to guidelines on the clinical development of medicines to treat or prevent diabetes. The revisions center on a section about cardiovascular safety, which the agency wants to update in light of a reflection paper it adopted in 2016.
In the current version of the diabetes guideline, which came into force in 2012, EMA devotes more than 1,000 words to a discussion of the long-term and cardiovascular safety of diabetes drugs. That advice was superseded by the reflection paper in 2016, prompting EMA to cut it from the guideline and direct readers to the other document. The revised section on cardiovascular safety is little more than 100 words long.
The need to revise the cardiovascular safety section was the main motivation for the update process EMA embarked upon in 2016 with the publication of a concept paper. EMA has also used the process to address some other topics, though.
The latest draft features reworked advice on diabetes complications, high-strength insulin, oral type 1 diabetes drugs and what it takes to win first-line approval. The new section on first-line use opens the door to approvals without first pitting products against metformin, provided “the robustness and magnitude of the glucose lowering effect of the test drug is very convincing.”
EMA is accepting feedback on the draft until 15 August. 
Draft Guideline
PRAC Calls for Warning Symbols on Valproate Packs to Prevent Prenatal Exposure
The Pharmacovigilance Risk Assessment Committee (PRAC) wants the packaging of valproate to carry  visual warnings about the risks the drug poses to unborn babies. PRAC thinks featuring boxed text and a pictogram on outer packaging can help prevent valproate use during pregnancy.
EMA’s PRAC included the use of pictograms in a broader risk-mitigation strategy. The proposal calls for the attachment of reminder cards to valproate packaging to encourage discussions between pharmacists and patients, and tasks manufacturers with updating educational materials. PRAC also wants to prohibit the use of valproate in pregnant women who suffer from migraines and bipolar disorder, while restricting its use in pregnant women who suffer from epilepsy.
The committee is proposing to allow women of childbearing age to take valproate provided a pregnancy prevention program is followed. This program features counseling, pregnancy tests and a new risk acknowledgement form patients and providers must go through during annual reviews of treatment plans.
PRAC began its investigation into valproate in March at the request of French authorities. That led to the committee holding its first public hearing on the safety of a medicine and other discussions that informed the recommendations.
“The PRAC noted that women were still not always receiving the right information in a timely manner and that further measures were needed to help avoid use during pregnancy. However, it was also clear that for some women, such as those with particular forms of epilepsy, valproate is the only appropriate treatment and might be life-saving,” the committee wrote.
PRAC Recommendations
EMA Increases Pharmacovigilance Fees After Two Flat Years
EMA has increased its pharmacovigilance fees by 1.4%. The action increases the fees in line with inflation since they were set in 2014.
The 1.4% increase reflects inflation of 0.2% in 2015 and 1.2% in 2016. The upshot is companies will pay slightly more for regulatory pharmacovigilance services from 12 February onward. For example, the cost of single assessments of periodic safety update reports now stands at €19,770 ($24,490) per procedure, up from €19,500 under the old fee structure.
EMA has applied the increase to all pharmacovigilance fees. Micro- to medium-sized enterprises still benefit from fee waivers and reductions.
EMA Notice, Explanatory Note
Other News:
EMA approved 60% more veterinary medicines last year than in 2016. The sharp rise took the number of approval recommendations up to 18. Vaccines accounted for 10 of the recommendations, twice as many as in the previous year. However, EMA only recommended one more new active substance for approval in 2017 — seven versus six the year before — and gave nods to fewer medicines for minor use minor species. EMA Notice, Annual Report
EMA has released a draft qualification opinion for consultation. The opinion covers the European Cystic Fibrosis Society Patient Registry (ECFSPR). In the document, EMA responds to six questions from the ECFSPR consortium and states the registry may be suitable for “use as a data source for regulatory purposes” in the context of certain types of study of cystic fibrosis medicines. Draft Opinion


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