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Regulatory Focus™ > News Articles > 2020 > 3 > EU Regulatory Roundup: MHRA Adopts Teleconferencing as Coronavirus Disrupts Regulators Across EU

EU Regulatory Roundup: MHRA Adopts Teleconferencing as Coronavirus Disrupts Regulators Across EU

Posted 19 March 2020 | By Nick Paul Taylor 

EU Regulatory Roundup: MHRA Adopts Teleconferencing as Coronavirus Disrupts Regulators Across EU

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
MHRA Adopts Teleconferencing as Coronavirus Disrupts Regulators Across EU
The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has switched to teleconferencing for scientific advice meetings. MHRA’s new policy is one of several actions taken by European regulatory agencies this week to adapt their operations to the coronavirus outbreak.
While the UK government initially took a softer approach to curbing the novel coronavirus than many of its peers, it stepped up its restrictions on the populace on Monday in light of new modeling of the risk of the virus overwhelming the health service. MHRA responded to the government’s new stance by using teleconferencing to hold all scientific advice meetings until further notice.
MHRA issued the notice days after its counterparts in Ireland and the Netherlands disclosed changes to their ways of working. Responding to advice by its government, the Health Products Regulatory Authority (HPRA) of Ireland canceled all face-to-face meetings at its offices. The ban is currently scheduled to run until 29 March, although the fact that the rate of new daily cases in Ireland is still accelerating suggests the restriction may stay in place beyond that date.
HPRA is contacting people affected by the ban to confirm if it will be possible to hold meetings via teleconference. Some meetings may need to be rearranged.
COVID-19 has also disrupted other aspects of HPRA’s operations. The agency has canceled all routine compliance inspections through to 29 March. If HPRA thinks an urgent inspection is needed, it plans to “follow public health advice in relation to any required precautions.”
HPRA staff are working remotely where feasible. The Dutch Medicines Evaluation Board (MEB) has also adopted home-working policies. MEB initially asked workers with mild cold symptoms and those living in North Brabant, the province at the center of the initial Dutch outbreak, to stay home. That policy was extended to cover all MEB employees late last week.
MEB has established a crisis team to figure out how to minimize disruption. The agency remains available by email and telephone, although it warned there may be delays in handling questions and requests.
MHRA Update, HPRA Notice, MEB Statement
Denmark Slashes Processing Times for Coronavirus Clinical Trial Filings by 90%
The Danish Medicines Agency (DKMA) plans to process filings to test drugs and vaccines against the novel coronavirus in around three days. DKMA typically takes 35 days to handle clinical trial filings, but expects to truncate the timeline by more than 90% to help counter the COVID-19 outbreak.
With the speed with which the coronavirus is spreading overwhelming healthcare systems, there is an urgent need for drugs and vaccines against the virus. DKMA has responded to that need by cutting all the fat from its clinical trial approval process, resulting in a workflow it thinks will yield a decision within three days without compromising safety.
DKMA unveiled the new timeline days after outlining how it is working to counter problems with the supply of critical medical devices. Working with regional bodies, DKMA is creating a national logistics center it hopes will prevent COVID-19 from causing shortages of vital pieces of equipment.
The initiative builds on existing work by DKMA and regional bodies to monitor supply. In the new phase of the initiative, the partners will benefit from an IT system that DKMA said will support the continuous updating of the supply situation.
DKMA Notice, More (Danish)
EMA Suspends Esmya Pending Safety Review Amid Ongoing Liver Concerns
The European Medicines Agency (EMA) has suspended Gedeon Richter’s Esmya while it performs another review of the safety of the treatment for uterine fibroids. EMA reviewed the safety of the drug in 2018, but the failure of subsequent risk-minimization measures to stop a new case of serious liver injury has persuaded it to reopen the case.
In 2018, EMA began requiring women to undergo liver tests before, during and after stopping treatment with Esmya. Only women without liver problems were permitted to take the drug under the new policy, which also limited use to one treatment course in people eligible for surgery.
The measures were intended to stop more liver injuries. However, EMA has learned of a woman who required a liver transplant after taking the medicine, despite the healthcare professionals adhering to the risk-minimization measures.
In light of the new case, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has advised women to stop taking 5 mg of Esmya for uterine fibroids. The action is intended to reduce the risk of further liver injuries occurring while PRAC updates its recommendations.
PRAC set out its interim position on Esmya after a meeting at which it also committed to look into a potential link between a form of ifosfamide and encephalopathy and provided new testing and treatment recommendations for fluorouracil.
EMA Notice, More
Ireland’s HPRA Issues Notice About Cyber Threat to Bluetooth Medical Devices
Ireland’s HPRA has issued a notice about cybersecurity vulnerabilities that affect some devices that use the Bluetooth Low Energy (BLE) protocol. HPRA is advising device manufacturers to assess if their products are affected and, if so, look for signs that the vulnerabilities have been exploited.
The vulnerabilities, known collectively as SweynTooth, enable hackers to crash, reboot or otherwise interfere with medical devices including pacemakers and insulin pumps. Researchers in Singapore first published details of the vulnerabilities last month, leading the United States Food and Drug Administration (FDA) to issue a safety advisory about the situation at the start of March.
Now, HPRA has documented the vulnerabilities and issued recommendations for manufacturers and healthcare professionals that draw on those provided by FDA. HPRA wants affected manufacturers to use their post-market surveillance activities to look for signs the vulnerabilities have been exploited.
The monitoring programs may struggle to identify attacks on vulnerable devices. HPRA said as much in its notice, stating that, while there are no reports of the vulnerability being exploited, “it would be very difficult to identify.”
HPRA Notice
Denmark Puts Limits on Medicine Purchases to Stop COVID-19-Fueled Hoarding
Denmark’s DKMA has put limits on the sale of prescription and over-the-counter (OTC) medicines to stop people from “hoarding” products. The restrictions stop pharmacies from giving patients more packs than they “normally consume” and limit sales of OTC medicines to one per customer.
DKMA framed the actions as a precaution needed to ensure the continued availability of medicines for the elderly, sick and infirm. In theory, a consumer could bypass the OTC restriction by purchasing medicines from multiple stores, but DKMA hopes people will “exhibit good citizenship” and not take actions that create unnecessary problems.
At this stage, DKMA is hoping the actions will be sufficient to maintain the supply of medicines. That could change in the future, with DKMA stating that it is following the situation and “other measures cannot be excluded.”
DKMA shared news of the restrictions days after it provided an update on its work with companies and authorities in Denmark and overseas to minimize disruption to the supply chain. In that notice, DKMA said it may redistribute medicines to the areas of the country where they are most needed.
DKMA Notice, More
Other News:
EMA has shared details of its plans to procure coaching and management development workshops. The goal is to strengthen the performance and practices of managers at the agency. EMA Notice


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