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Regulatory Focus™ > News Articles > 2020 > 4 > EU Regulatory Roundup: MHRA offers advice on maintaining and calibrating equipment during lockdown

EU Regulatory Roundup: MHRA offers advice on maintaining and calibrating equipment during lockdown

Posted 09 April 2020 | By Nick Paul Taylor 

EU Regulatory Roundup: MHRA offers advice on maintaining and calibrating equipment during lockdown

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
 
MHRA Offers Advice on Maintaining and Calibrating Equipment During Lockdown
 
The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has provided guidance to manufacturers and laboratories that need outside engineers to maintain or calibrate their equipment during the COVID-19 pandemic.
 
Typically, manufacturers and laboratories ask external service personnel and engineering support staff to visit their facilities to perform maintenance and calibration work. These support staff help keep the equipment functioning and the facilities in compliance with good regulatory practices. However, at a time of government-mandated social distancing it may be difficult for companies to arrange onsite visits by external engineers and service personnel.
 
Recognizing that, MHRA has provided a slate of options for companies that need their equipment maintained or calibrated. If an engineer is able to visit the site, the company should assess the risk of COVID-19 transmission and take steps to ensure they are kept physically apart from other staff and adequately supervised. MHRA is allowing electronic signatures of protocols and site visit documents.
 
In other cases, an engineer may only be able to engage with a site by telephone or video call. MHRA is permitting companies in that situation to task a “suitably trained employee” to carry out the work under the remote supervision of the engineer. Companies that take that option should assess the risk of doing so and potentially bring forward their next onsite visit by an engineer when the restrictions on face-to-face contact are lifted.
 
MHRA’s guidance also offers advice to companies that are unable to access even remote support. In that scenario, MHRA wants companies to raise a quality system record and assess the risk of delaying the maintenance or calibration task. If a piece of equipment is taken out of service following the risk assessment, the outstanding maintenance or calibration task should be performed before it is used.
 
The guidance covers two other options. If equipment can be sent offsite, companies can do so if they assess and detail the risks of deviating from standard practice. Finally, MHRA has given companies the go ahead to use laboratory equipment other than the make and model validated in analytical methods. 
 
MHRA Guidance
 
Switzerland Takes Steps to Stop COVID-19 Causing Shortages of Essential Supplies
 
Switzerland has adopted measures intended to prevent shortages of medical supplies essential to the management of COVID-19. The actions grant the Swiss Agency for Therapeutic Products (Swissmedic) the power to clear some products for use in Switzerland despite the lack of the required evidence.
 
Following the change, Swissmedic can sign off on the use of medical devices even if their developer is yet to complete the conformity assessment procedure. In assessing whether to lower the bar, the Swiss regulator will consider demand for the type of medical device under review and the evidence available to support its use.
 
In the absence of a completed conformity assessment procedure, Swissmedic will look for evidence the device meets the essential requirements and poses acceptable risks in the context of the benefits to the patient. Ventilators and surgical masks are among the types of products that could come to market in Switzerland under the emergency pathway.
 
Companies that want to use the pathway should email an application to Swissmedic. The agency is asking applicants to include documents including authorizations in other markets and details of the number of devices they plan to ship to Switzerland.
 
Swissmedic disclosed details of the new powers alongside information about other steps taken by the Swiss Federal Council to get a handle on the supply situation. The other steps give authorities more power to coordinate the supply of medical products, for example by requiring Swiss regions to disclose their stocks of certain products.
 
Swissmedic Notice, More
 
EMA, Global Peers Discuss Using Real-World Data to Fill COVID-19 Evidence Gaps
 
The European Medicines Agency (EMA) and people representing 27 other regulatory authorities have discussed how to use real-world data to fill gaps in the evidence about treatments for COVID-19.
 
With the urgency of the pandemic pressuring regulators to authorize drugs and vaccines as quickly as possible, there is potential for products to come to market without the amount of clinical trial safety and efficacy data typically required for approval. Equally, observational studies are better placed than clinical trials to answer some questions about COVID-19 and products developed against the virus.
 
At a virtual International Coalition of Medicines Regulatory Authorities event co-chaired by EMA and Health Canada, regulators exchanged ideas about how to use observational studies to generate data on COVID-19 drugs and vaccines.
 
“They discussed observational studies in different countries and exchanged practical information about research questions, protocols and procedures to ensure the reliability of results needed to meet regulatory requirements. Sharing of protocols and results was identified as a critical aspect of the global approach,” EMA wrote in its summary of the workshop.
 
EMA Statement
 
France Takes Precautions as COVID-19 Fuels Talk of Using Animal Medicines in Humans
 
France’s drug regulator has asked healthcare professionals to take care to avoid medication errors as the COVID-19 crisis forces them to substitute medicines for products that are in short supply.
 
In a statement outlining the situation, the French National Agency for Medicines and Health Products Safety (ANSM) said manufacturers have committed to upping production of certain products while importing supplies to help make up shortfalls created by the COVID-19 pandemic. However, ANSM thinks those actions may fail to prevent all supply disruptions.
 
As such, the regulator is advising that veterinary medicines deemed comparable to human therapies may be given to people in exceptional circumstances.
 
Recognizing the risk of medication errors linked to that possibility and other aspects of the pandemic, ANSM is asking pharmacists to communicate special precautions they should take when using certain products. Pharmacists will share the information using standardized sheets validated by ANSM.
 
ANSM Notice (French)
 
MHRA Investigates Companies Selling Bogus COVID-19 Medical Products Online
 
MHRA is investigating cases of fake or unlicensed medical products marketed for use in the diagnosis, prevention and treatment of COVID-19.
 
The pandemic and lack of authorized products against it has created opportunities for unscrupulous or misinformed actors to promote fake and unlicensed interventions. MHRA has identified some of those actors and acted against them, leading to the disabling of nine domain names and social media accounts accused of selling fake or unauthorized products.
 
In disclosing the actions, MHRA said it has seen companies promoting “miracle cures” and “antiviral misting sprays,” as well as self-testing kits and unlicensed medicines. MHRA is now running 14 investigations. The National Crime Agency is also investigating reports of the sale of fake drugs and working with MHRA to gauge the extent of the illegal activity and the threat it poses to the public.
 
Another UK agency, the National Fraud Intelligence Bureau, has received reports that in some cases companies are failing to provide personal protective equipment and self-testing kits ordered online.
 
MHRA Statement
 
Other News:
 
MHRA has shared details of an exchange of adrenaline auto-injector pens. People with Emerade 300 microgram pens are to contact their prescribers to seek a replacement from a different brand. The exchange follows the recall of Emerade products due to difficulty activating the pens. MHRA wants patients to follow advice on social distancing while exchanging their pens. MHRA Notice
 

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