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Posted 01 February 2018 | By Nick Paul Taylor
Welcome to our EU Regulatory Roundup, our weekly overview of the top regulatory news in Europe.
The European Medicines Agency's (EMA) move to Amsterdam has been complicated by struggles to find a temporary location. Identifying a suitable temporary base took longer than expected, and the ticking clock has ultimately forced EMA to accept a site that falls well short of its ideal home.
Critically, the temporary site proposed by Dutch officials is half the size of the building EMA currently occupies in London. That will create problems for EMA, but the time-pressured nature of the move means the agency has decided these issues are now the lesser of two evils. EMA needs a site that is ready to host its staff from the start of next year. The temporary site ticks that box.
"Even if these temporary premises are not ideal, they are the best option under the current time restrictions," EMA executive director Guido Rasi said at a press conference to discuss the relocation.
EMA agreed to move into the building after rejecting the first temporary location put forward by its Dutch partners. This back and forth dragged on for longer than expected, ratcheting up the pressure on EMA to accept the second proposal despite its shortcomings. EMA will spend most of 2019 in the temporary building while it waits for the Netherlands to complete work on its permanent base.
That will make next year, which under the best of circumstances would be a tricky time for EMA, a particularly challenging 12 months. The agency will need to move into and out of its temporary site. Rasi said the double move will force EMA to invest more resources and push back the date by which its activities will get back up to full speed. In between the two moves, EMA will occupy a building that fails to fully meet its needs.
"For the offices, I think we have enough [space] with some less comfortable solutions. It is workable," Rasi said.
EMA will have enough space to run its core business from the building, but staff will need to hold some meetings at external venues. Exactly how tight a squeeze it is to get everyone into the building will depend on what proportion of EMA staff move from London to Amsterdam and how fast the agency can replace those who stay behind.
Amsterdam scored highly when EMA polled its staff last year, suggesting the majority of people will keep working for the regulator. EMA will get a clearer picture of the likely loss of expertise when it repolls staff later this year. The agency is waiting on information from Dutch officials about schooling before asking staff whether they will make the move to Amsterdam.
Press Conference, Rasi Statement
EMA is seeking feedback on the use of molecular neuroimaging to identify early manifestations of Parkinson's disease. The request follows a submission by a multinational consortium of pharmaceutical companies and other groups with an interest in advancing drugs against Parkinson's.
The consortium, Critical Path Global, sought a qualification opinion on the use of neuroimaging of the dopamine transporter as a biomarker for early manifestations of Parkinson's. Success would open the door to the use of use of low baseline dopamine transporter levels to identify patients in the early stages of Parkinson's who are suitable for participation in clinical trials. These trials could exclude patients who are unlikely to progress owing to their dopamine levels.
"It is envisioned that the biomarker can help predict which individuals will have negligible progression rates, subjects defined as scans without evidence of dopamine deficiency, and which individuals will have detectable and clinically relevant progression rates over the course of clinical trials of up to two years in duration," EMA wrote in its draft qualification opinion.
The Committee for Medicinal Products for Human Use (CHMP) intends to qualify neuroimaging of the dopamine transporter as "an enrichment biomarker in Parkinson's disease clinical trials targeting early motor stages of the disease." CHMP is accepting feedback on the wisdom of this preliminary ruling until 7 March.
The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) is continuing its efforts to stop the diversion of prescription medicines by criminals. MHRA thinks as much as $280 million worth of pharmaceuticals were diverted into illegal channels in the UK from 2013 to 2016.
Officials at MHRA first glimpsed the extent of the enterprise toward the end of that period, when they discovered a significant diversion of benzodiazepines and other hypnotics. That led to the launch of a large-scale investigation late in 2016 and further actions throughout the following year. In 2017, the agency expanded its activities to include 19 active investigations and made more than 40 arrests.
MHRA has focused its attention on benzodiazepines, anxiolytics such as diazepam and zopiclone and the painkiller tramadol. In doing so, MHRA has accrued evidence that legitimate medicines are being sold online illegally. The agency has implicated pharmacists in the wrongdoing.
"We are working closely with the MHRA on the ongoing investigations into these very serious criminal offences. We have already taken action to suspend five pharmacists under interim orders and are actively reviewing at each stage of the investigations whether we need to take further action to protect the public," Duncan Rudkin, chief executive of General Pharmaceutical Council, said.
MHRA has found no evidence medicine shortages have resulted from the diversion of pharmaceuticals.
The Committee for Medicinal Products for Veterinary Use (CVMP) is planning to revise a guideline on the safety and residue data requirements for minor use or minor species (MUMS) products. CVMP wants to rewrite the guideline to bring it in line with current rules on extrapolating maximum residue limits.
The European Commission published new rules on residue limits last year. That forced CVMP to adapt its approach to extrapolation, thereby rendering its guidance on MUMS data requirements out of date. CVMP has begun the process of fixing the disconnect between its practices and documents by publishing a draft concept paper.
CVMP is accepting feedback on the brief concept paper until the end of next month. The goal is to have a revised guideline ready for public consultation in the fourth quarter of this year. Assuming all goes to plan, CVMP will adopt the final version of the guideline in the first half of 2019.
The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has backed calls to suspend the marketing authorizations of hydroxyethyl-starch solutions for infusion. EMA's pharmacovigilance committee recommended the suspension of the products earlier this year after analyzing the risk of kidney injuries and death. CMDh Notice
CHMP has recommended a clutch of new drugs for approval and knocked back others during a busy first meeting of 2018. The committee voiced its support for Roche's hemophilia A drug Hemlibra, Chiesi Farmaceutici's enzyme replacement therapy and GlaxoSmithKline's shingles vaccine Shingrix. CHMP also gave negative opinions to Renable Pharma and Santhera Pharmaceuticals. CHMP Notice
MHRA has formed a memorandum of understanding with Health Inspectorate Wales. MHRA Notice
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