European Regulatory Roundup: EMA Explains its Regulatory System (14 September 2017)

Regulatory NewsRegulatory News | 14 September 2017 |  By 

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

EMA Gathers Global Drug Agencies, NGOs to Explain its Regulatory System

The European Medicines Agency (EMA) is meeting with medicine agencies and non-governmental organizations (NGOs) to explain its regulatory system. EMA sees the education initiative helping other global regulators understand its system and, by extension, more effectively collaborate with its staff.

EMA has scheduled the meeting, the first of its kind, for next week and is webcasting the event for people who cannot attend in person. The event is one part of EMA’s response to the globalization of the industries it regulates. Specifically, EMA hopes that if NGOs and other regulatory agencies understand how it works, they will be better placed to collaborate with it on the growing list of tasks that benefit from international cooperation.

The schedule for the free, two-day event touches on most of the tasks EMA is involved with, including clinical trials, good practices, inspections, pharmacovigilance and the publication of clinical data. Importantly given EMA’s desire for the event to foster more effective collaborations, the event has also set aside more than one hour to discuss international cooperation. EMA has also allocated time for attendees to meet with its staff.

EMA is holding the event four months after it met with regulatory agencies from countries in east Africa. That meeting gave the African regulators a chance to learn about the structure of EMA with a view to setting up a similar regional organization covering their countries. The latest meeting also comes weeks after EMA stepped up its cooperation with the United States Food and Drug Administration by agreeing to share commercially confidential information.

Collectively, the activities are testament to EMA’s belief the international cooperation is the best way to manage the challenges created by the globalization of the drug and medical device sectors.

EMA Notice, Meeting Agenda

Irish Regulator Steps up Biosimilar Education Drive With Healthcare Professional Event

The Irish medicine regulator is holding an event to tell healthcare professionals about biosimilars. Experts from the Irish Health Products Regulatory Authority (HPRA) will use the event to discuss topics including biosimilar quality and data requirements.

HPRA’s decision to gather healthcare professionals to talk about these matters and other big topics such as pharmacovigilance, interchangeability and international trends comes against a backdrop of slow biosimilar uptake in Ireland. The slow uptake only partly stems from the prescribing habits of healthcare professionals — just 11 of the roughly 30 EMA-approved biosimilars are reimbursed in Ireland — but HPRA sees value in educating members of this community.

News of the event comes weeks after Ireland began a consultation on its biosimilar policy. The consultation is seeking to answer some fundamental questions, such as whether respondents were aware of biosimilars and their legal and regulatory status in Ireland before receiving the document.

The consultation could trigger changes that affect healthcare professionals, most notably if it leads Ireland to revise its stance on prescriber-led switching and pharmacy-led substitution. Leading members of the government have reservations about switching and substitution. The consultation will have closed by the time the HPRA event takes place next month.

HPRA Notice

Danish Regulator Highlights Price Difference Between Beta-Blockers to Save Money

The Danish Health Authority (SST) has alerted doctors to a significant price difference between two beta-blockers. SST found Metoprolol "GEA" costs 12 times as much as some other formulations of metoprolol, prompting it to tell doctors to think carefully when writing out prescriptions.

Such care is necessary, as generic metoprolol succinate cannot be substituted for Metoprolol “GEA,” a metoprolol tartrate formulation, because of minor differences in their release profiles. Previously, pharmacies could switch patients to another metoprolol tartrate depot formulation, but this disappeared from the market in 2015. As such, once a patient is prescribed Metoprolol “GEA” they stay on the drug unless their doctor rewrites their script.

A Danish drug pricing website states the price-per-unit of 50 mg Metoprolol “GEA” is about Kr 5 ($0.80). Other 50 mg metoprolol tablets sell for less than Kr 1.

The differences between the prices of the drugs have increased in recent years. SST said the price of Metoprolol “GEA” has roughly doubled since 2007. The cost of other metoprolol formulations has fallen over the same period.

Denmark’s drug pricing site lists Metoprolol “GEA” as being sold by GEA Farmaceutisk Fabrik, which was acquired by Hexal. Novartis bought Hexal in 2005. 

SST Notice (Danish)

MHRA Raids Lead to Back-to-Back Convictions of Unlicensed Drug Suppliers

Raids by the Medicines and Healthcare products Regulatory Agency (MHRA) have led to prison terms for two sellers of unlicensed medicines. One of the men faces 20 months in prison, while the other is sentenced to spend 20 weeks behind bars.

The man who received the longer of the two sentences was found with more than 100,000 doses of an unlicensed erectile dysfunction medicine. That is about seven times as many doses as were found at the property of the man who received the 20-week sentence, although MHRA placed a higher monetary value on this smaller haul of unlicensed erectile dysfunction medicines.

MHRA discovered the doses during raids on properties owned by the two people now facing prison terms. The raid that uncovered 100,000 doses also found a smaller quantity of prescription drugs. 

MHRA Statement, More

Danish Medicines Agency to Expand Use of Electronic Communication Next Month

The Danish Medicines Agency (DKMA) is to send marketing authorization decisions and annexes to local firms electronically from next month. Companies based outside Denmark will continue to receive DKMA decisions on their filings by mail.

DKMA has decided to move over to electronic communication with Danish companies after putting extra security measures in place. Applicants will receive decisions via encrypted post, resulting in a level of security DKMA thinks is superior to that provided by email and traditional mail.

The decision to switch to electronic communication comes 10 months after DKMA adopted an IT strategy for the next few years.

DKMA Notice

Other News:

MHRA has issued an alert about ventilators sold by ResMed. The alert outlines the steps users of the device should take to mitigate the risk the internal battery will shut down. MHRA is advising users to ensure a backup power source and external source of ventilation are available until the devices are returned to a service center. The notice comes three months after a related field safety notice. MHRA Alert

The European Parliament's Committee on Environment, Public Health and Food Safety (ENVI) has met with Vytenis Andriukaitis to discuss the illegal use of fipronil insecticide in poultry farms. The discussion was prompted by the discovery of chicken eggs contaminated with fipronil in 22 countries in the European Union. Andriukaitis is Lithuania's European commissioner. ENVI Notice

EMA is hosting a meeting to raise awareness of the dangers posed by resistance to antimicrobials. The medicine agency has organized the meeting with the European Centre for Disease Prevention and Control (ECDC). One objective is to improve understanding of the role EMA and ECDC can play in global initiatives against antimicrobial resistance. EMA Notice, Draft Agenda

The Committee for Medicinal Products for Veterinary Use (CVMP) has reached consensus positive opinions on three initial marketing authorization applications. CVMP gave the green lights to drugs and vaccines targeting beehive dispersion, feline leukemia and bluetongue virus. CVMP Statement


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