Euro Regulatory Roundup: MHRA creates synthetic dataset to support COVID-19 research

RoundupsRoundups | 30 July 2020 |  By 

The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has created a synthetic dataset to support development of medical technologies for use in the response to COVID-19.
Developers of machine learning algorithms need health data to validate and benchmark their technologies. However, the strict regulation of even pseudonymised data, and lingering privacy fears related to its use, make it hard and expensive for researchers to access the resources they require. Synthetic datasets eliminate those concerns by mirroring, but not containing, real-world data.
Synthetic datasets are designed to cover the symptoms, diagnoses and treatments of actual patients. The data is entirely artificial, though, mitigating privacy concerns and increasing researcher access to the resource. MHRA has made synthetic datasets for COVID-19 and cardiovascular disease.
“This development will support bringing safe products to market sooner, enabling patients to benefit from the latest technical advances,” Janet Valentine, director of Clinical Practice Research Datalink (CPRD), said in a statement.
CPRD, a real-world research service co-sponsored by MHRA, made the COVID-19 synthetic dataset by extracting data on patients with suspected or confirmed coronavirus infections in the UK. No patient data is included in the synthetic dataset, but, by following a synthetic primary care data generation framework, CPRD has created a resource designed to mirror the symptoms and sociodemographic and clinical risk factors seen in the real world.
MHRA announced the COVID-19 synthetic dataset alongside a similar resource aimed at developers of products targeting cardiovascular disease. The cardiovascular disease project served as a proof of concept for the synthetic dataset initiative.
MHRA is now accepting applications from researchers who want to access the synthetic datasets. MHRA wants to know how applicants intend to use the datasets.
MHRA Notice, More
Swissmedic to require electronic submission of major change notifications
The Swiss Agency for Therapeutic Products (Swissmedic) will move to the electronic submission of notifications of major changes in the fall and wants organizations affected by the change to apply to access the eGov portal immediately.
The switch to eGov will guarantee secure data communication, according to Swissmedic. Companies will need to make some changes to realize that benefit.
Companies need an establishment license issued from the start of January 2019 onward to access eGov services. Companies that do not meet that requirement should apply to have their licenses transferred to the new format, according to Swissmedic. Companies will be unable to apply to access eGov until the transfer is complete. Even companies with eGov access need to apply to use the new service.
Swissmedic plans to provide more information about the changes next month but is advising groups affected by the new process to start working through the steps needed to gain access straight away. 
Swissmedic Notice
Ireland’s HPRA warns about direct-to-consumer COVID-19 tests
Ireland’s Health Products Regulatory Authority (HPRA) has issued an alert about direct-to-consumer tests for SARS-CoV-2 and antibodies against the virus. HPRA is advising consumers not to buy tests as they may be inaccurate, and their results may not be accessible to health authorities.
People in Ireland who have COVID-19 symptoms or have been in close contact with someone who is positive for the virus can get tested for free through a national program, with test results reported centrally to support monitoring, surveillance and contact tracing.
However, HPRA is “aware of several commercial tests” that enable people to get tested without using the Health and Safety Executive service. Molecular and serologic tests are available commercially.
HPRA is advising against the use of commercial molecular tests as they involve self-swabbing. While other countries, including the UK, support self-swabbing, Ireland’s current position is that healthcare professionals should collect samples to ensure the specimens are suitable for analysis. HPRA is also concerned Ireland’s surveillance program may not learn of positive results from commercial tests.
The agency has a separate set of concerns about commercial serologic assays. Specifically, HPRA is unsure if the presence of antibodies means a person is immune and is therefore currently against the widespread use of serologic tests.
HPRA Notice
Spain’s AEMPS seeks to limit use of remdesivir to ensure availability
The Spanish Agency of Medicines and Medical Devices (AEMPS) is asking physicians to limit the use of Gilead Sciences’ COVID-19 drug remdesivir to certain patients to prevent a supply shortage.
AEMPS recommends up to five-day courses of remdesivir, the antiviral sold as Veklury, are given to hospitalized COVID-19 patients who need supplemental oxygen but are not mechanically ventilated or on extracorporeal membrane oxygenation (ECMO). The recommendation reflects evidence on  remdesivir, which failed to improve outcomes in patients on mechanical ventilation or ECMO.
The use of remdesivir outside of the contexts recommended by AEMPS should take place in clinical trials. That will generate data on the efficacy of remdesivir in other patient populations and ensure Spain’s commercial supplies of remdesivir are used in patients who are most likely to benefit.
AEMPS said Spain has enough remdesivir stock to cover current needs in the authorized indication. The agency’s recommendation that remdesivir is given for up to five days differs somewhat from the drug’s European approval, which states it should be administered for between five and 10 days.
AEMPS Notice (Spanish)
MHRA highlights issuance of device certificates with no legal standing
MHRA has issued a statement about the issuance of paperwork headed “certificates of compliance” or “attestation of compliance” by certification bodies. The agency is advising the industry that such documents are not evidence that a manufacturer is compliant with regulatory requirements.
Certification bodies sometimes issue certificates and attestations of compliance after reviewing the technical documentation of a medical device. However, as MHRA states in its notice, the bodies do not need to issue such documents. The documents neither indicate compliance with the UK Medical Device Regulations 2002, nor do they serve as CE certificates.
MHRA clarified the regulatory status of the documents without explaining the context beyond a line that it “is aware of certificates being issued by certification bodies.” The notice follows alerts by some of MHRA’s European peers about invalid paperwork purporting to show the compliance of COVID-19 devices. 
MHRA Notice
Other News:
MHRA has shared details of a recall of a sublingual fentanyl formulation sold by Kyowa Kirin in the UK. Kyowa Kirin initiated the recall after receiving reports that some blister pockets contained two tablets. MHRA said “this was identified during reference sample inspection and there is a potential low risk of accidental double dosage.” MHRA Notice
Spain’s AEMPS has reported a 5.4% decline in human use of antibiotics. The decline, which happened last year, was accompanied by a 13.6% drop in sales of veterinary antibiotics. The reductions continue trends seen in recent years, resulting in double-digit declines in the use of human and veterinary antibiotics since 2015. Hospital use of antibiotics rose as COVID-19 spread. AEMPS Notice (Spanish)


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