EU Regulatory Roundup: MHRA Offers Advice on Managing Clinical Trials During COVID-19 Outbreak

| 26 March 2020 | By Nick Paul Taylor 

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
MHRA Offers Advice on Managing Clinical Trials During COVID-19 Outbreak
The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has provided guidance on how to manage clinical trials during the COVID-19 outbreak. With the pandemic and government responses to it disrupting studies, the MHRA guidance offers sponsors advice on how to deal with some of the situations they may face.
In the text, MHRA recognizes that “clinical trial resource may be absent or redeployed from research activities and regulatory affairs towards front-line care,” leading it to commit to being “as flexible and pragmatic as possible with regard to regulatory requirements for clinical trials during this time.” That position, coupled to the prioritization of the safety of study subjects, informs the guidance.
MHRA is advising sponsors that halt studies because of COVID-19 that they will ordinarily not need to inform the agency, although they should put a note about the action in the trial master file. Sponsors that stop trials because of safety concerns or supply issues should contact MHRA.
The guidance also covers how clinical trials can keep going despite the disruption. MHRA is allowing sponsors to ship investigational medicinal products to the homes of patients who cannot travel to trial sites. Sponsors in that situation should do a risk assessment, noting the process internally, but do not need to send a substantial amendment notification to MHRA.
MHRA has also voiced its support for the use of other approaches that enable subjects to remain in trials despite having reduced or zero access to study sites. The guidance permits remote monitoring, although MHRA advises sponsors to consider issues relating to patient consent, confidentiality and the burden on investigators before taking that option. MHRA is allowing sponsors to replace in-person visits with phone calls and reduce participant monitoring visits without filing substantial amendments.
Other parts of the guidance also demonstrate enforcement discretion. MHRA accepts that sponsors may fail to share safety filings and end of trial notifications on time due to capacity constraints. The agency does not expect sponsors to file a substantial amendment if they deviate from the timelines defined in their protocols. Similarly, MHRA expects more protocol deviations and will neither class an uptick as a serious breach nor require sponsors to report such trends.
MHRA plans to update the guidance as the situation changes and has already added to the original text. The agency published the original version of the guidance the day before revealing it is stopping all non-essential good practice inspections. MHRA will focus the inspections it does carry out on sites linked to the UK’s response against COVID-19.
MHRA Notice, More
Ireland, Switzerland Open Door to use of Non-CE Marked Medical Devices
Ireland and Switzerland have outlined pathways for getting unauthorized medical devices to patients for use in the COVID-19 pandemic. The pathways permit manufacturers and healthcare professionals to seek permission to get essential devices to patients without meeting the usual requirements.
In Ireland, the Healthcare Products Regulatory Authority (HPRA) opened the door to the provision of non-CE marked devices by publishing two forms, one aimed at manufacturers, another designed for doctors.
The document designed for doctors takes the form of a letter to the head of HPRA’s medical device department. A prefilled section of the letter states, “It is my opinion that the use of the below mentioned non-CE marked device is essential for use on patients suffering with COVID-19 during the current pandemic crisis as a matter of urgent public health need.” All the doctor needs to do is fill in details such as of the name of the device and the facilities where it will be used.
HPRA’s form for manufacturers is more comprehensive. Manufacturers need to provide a reason for requesting the use of a non-CE marked medical device and details of the risk-benefit analysis. HPRA also wants manufacturers to submit details of any clinical investigations involving the device and a list of the international standards with which it complies.
Neither HPRA document names a type of medical device as being suitable for the pathway. The Swiss Agency for Therapeutic Products (Swissmedic) was more forthcoming in its notice, stating that it will allow the use of non-compliant medical devices to cope with “the risk of a critical shortage of ventilators arising as the pandemic continues.”
Swissmedic Notice, HPRA Form, More
Denmark’s DKMA Gains Powers to Counter COVID-19 Supply Problems
The Danish Medicines Agency (DKMA) has gained the power to reallocate medicines and medical devices to parts of the country that need them most. DKMA will build a picture of the situation in the country by asking companies, regions and municipalities to share details of their supplies.
A surge in COVID-19 cases in one part of Denmark could overwhelm local healthcare capacity, despite their being excess capacity at a national level. If that happens, DKMA now has the power to divert resources to where they are needed most, moving personal protective equipment and other products around the country as required. If needed, DKMA can also regulate drug and device prices.
DKMA issued a notice about its new powers on the same day as it shared details of its collaboration with an industry association. The collaborators will work to get more manufacturing plants making face masks and other protective equipment. DKMA framed the collaboration as part of its “Denmark helps Denmark” campaign to get the country to work together and source materials to fight COVID-19. 
The actions were part of a clutch of initiatives unveiled by DKMA this week. DKMA also revealed it has restricted the sale of paracetamol for children by taking packs off the shelves of supermarkets and other retail outlets. Parents can buy paracetamol suppositories over the counter at pharmacies but need a prescription to obtain the drug as an oral suspension.
DKMA Notice, More
MHRA Creates Form to Help Manufacturers Get COVID-19 Tests to Market
MHRA has created a form to help manufacturers of CE-marked professional use COVID-19 test kits to the UK market. The publication of the form comes as the UK tries to ramp up testing capacity to cope with the spread of the pandemic coronavirus.
In light of that effort, MHRA has asked manufacturers and suppliers of CE-marked tests designed for use by clinicians to complete and submit a form. MHRA is using the form to gather information about evidence to support the use of COVID-19 tests, such as their analytical specificity and clinical sensitivity, and the time and steps involved in using different types of diagnostics.
The agency also wants to know how many tests companies can supply and over what timeframe. Other details covered by the form include the cost per test and other spending associated with their use. MHRA will tell companies that submit completed forms whether their tests can be placed on the market.
MHRA used its notice about the availability of the form to disclose that it is developing specifications for COVID-19 tests and will make them available “as soon as possible.” The notice also addresses the sale of COVID-19 tests in pharmacies, noting that the UK public health agency is advising against their use. No home-use tests are available in the UK. 
MHRA Notice
Other News:
MHRA has published information for organizations that want to run COVID-19 clinical trials. MHRA Guidance


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