Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
MEPs Set Timeline for EMA Headquarters Move to Amsterdam
Members of European Parliament (MEPs) on Thursday ensured that the European Medicines Agency’s (EMA) headquarters and nearly 900 staffers are moved from London to its temporary location in Amsterdam no later than 1 January 2019, and to its new permanent headquarters no later than 16 November 2019.
Lead MEP Giovanni La Via said: “We are concerned about the risk of delay in the construction of the new Vivaldi building in Amsterdam, as this could cause a deterioration of the agency’s workflow, which is precisely what we want to avoid.”
The resolution was passed by Parliament by a vote of 507 votes to 112, with 37 abstentions.
MEPs will now start informal three-way negotiations with the Council Presidency and Commission to strike a first-reading agreement on the new EMA seat.
; ENVI Amendments
EU Industrial Strategy Calls for Regulatory Burden Reduction Targets
The European Council has adopted an industrial policy strategy that argues for “concrete targets” for the reduction of regulatory burdens. Officials think such targets are needed to make the EU globally competitive.
The Council settled on the policy document after holding talks last year that identified the need for a “comprehensive and long-term EU industrial strategy.” The scope of the document extends beyond the regulation of the life sciences industry but includes statements with implications for the oversight of drugs and devices in the EU.
In the document, the Council argues companies need a “clear, predictable and non-discriminatory regulatory environment in order to make future-oriented investments,” before going on to advocate for policies that try to reduce the burden oversight places on industry.
The Council’s desire to limit oversight stems from a belief “that the reduction of unnecessary regulatory burdens are an indispensable part of any comprehensive effort to support the global competitiveness of EU industry.” To further that goal, the Council wants officials to set goals for the reduction of regulatory burdens.
That proposal and others articulated in the strategy have potentially significant implications for the future of the EU, but it will be years before the effects become fully apparent.
“What we do now will determine where our economy and society will be in a decade. This underlines the need for us to have a broader, long-term and forward-looking approach,” Emil Karanikolov, the Bulgarian economy minister, said.
PRAC Plans Second-Ever Public Hearing to Support Antibiotic Safety Review
EMA has scheduled its second-ever public drug safety hearing. The agency’s Pharmacovigilance Risk Assessment Committee (PRAC) will hold the event in June to give the public a chance to inform its review of the risks and benefits of quinolone and fluoroquinolone antibiotics.
PRAC began the review 13 months ago at the request of the German drug regulator, which had seen reports of long-lasting side effects in its safety database and the medical literature. The antibiotics are known to seriously affect the muscles, joints and nervous systems of some patients but had never previously been subject to an EU-wide review.
Recognizing the importance of quinolone and fluoroquinolone to the treatment of life-threatening infections, PRAC recommended doctors continue to follow official prescribing information while the review is underway.
PRAC spent last year asking questions and analyzing the risk-benefit profile of quinolone and fluoroquinolone with a view to reaching a position on the use of the drugs — which are sometimes prescribed to treat relatively minor infections — but has decided it wants to hear from the public before finalizing its recommendation. The committee will hold the public hearing at its June meeting and make its recommendation the following month.
The decision to hold a public hearing comes six months after PRAC first held such an event. That hearing looked at the safety of valproate, a drug to treat epilepsy, bipolar disorder and migraine that is linked to adverse events when taken during pregnancy.
In line with guidance established before the valproate meeting, PRAC will share a list of specific questions ahead of the June event to shape the discussion about quinolone and fluoroquinolone.
PRAC revealed its plans to hold a public hearing at its meeting last week. The committee also used the meeting to recommend against using Xofigo with Zytiga and prednisone. PRAC made the ruling after analyzing clinical trial data linking the combination of the prostate cancer drugs and immunosuppressant to a greater risk of death and fractures.
FDA Starts Mutual Recognition Capability Assessment of Ireland’s HPRA
The United States Food and Drug Administration (FDA) has begun its assessment of the capabilities of the Irish drug regulator. FDA initiated the assessment as part of its preparations for the full initiation of its mutual recognition agreement with the EU.
Ireland’s Health Products Regulatory Authority (HPRA) disclosed the start of the FDA assessment in an update about the mutual recognition agreement. HPRA said it gave FDA documents related to the formal capability assessment in mid-November. More recently, HPRA learned FDA has started the review.
That makes HPRA part of one of the later waves of assessments undertaken by FDA. The US agency completed reviews of eight member states last year and a finished a further four assessments at the start of this month. The plan is to complete the rest of the assessments in batches between now and the middle of next year.
Once the assessment process is complete, batch testing of imports from the US will stop. That is one of several provisions covered by the agreement to reduce the duplication of regulatory efforts.
EMA has amended its submission timelines for industry on publishing clinical data. The agency is now proposing procedures in chronological order of its Committee for Human Medicinal Products (CHMP) opinion or withdrawal date. EMA said it “will send companies invitation letters 6 months in advance of the requested submission date.” And as of March 2018, EMA said it is processing procedures adopted by CHMP in the fourth quarter of 2016. EMA
A coalition of trade groups and patient bodies has sent a list of questions they want Brexit
negotiators to resolve during the second phase of talks about the United Kingdom’s split from the EU. The questions are designed to encourage negotiators to consider how their decisions will affect the supply of medicines and how long it takes for new drugs to come to market. Brexit Questions