Euro Roundup: MHRA shares guidance on coordinated assessment pathway for device trials

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on the coordinated assessment pathway it is piloting to streamline the review of clinical investigations involving medical devices.
 
MHRA and the Health Research Authority (HRA), which makes sure research is ethically reviewed and approved, are working together to test the pathway. The two organizations are sharing information on their assessments of medical device clinical investigations. Currently, MHRA and Research Ethics Committees (RECs), which review research applications as part of the HRA approval process, are working in parallel on their assessments of applications.
 
The agencies need applicants to take certain steps to support the testing of the coordinated assessment pathway. As the guidance states, applicants must be in a position to file the MHRA and REC applications at the start of the process. MHRA is advising the teams responsible for regulatory and ethics submissions to work together to ensure they are both ready to file.
 
Applicants need to tell MHRA they want to take part in the pathway and confirm certain details about their studies. The applicant should file with MHRA, wait for confirmation that the device submission is valid and then send the REC submission. MHRA plans to share its assessment with the REC assigned to an investigation before the meeting of the ethics committee. The REC will then share its discussion with MHRA.
 
MHRA Guidance
 
EDQM seeks feedback on 48 draft European Pharmacopoeia texts
 
The European Directorate for the Quality of Medicine (EDQM) has released details of 48 pharmacopeia texts that have undergone technical revisions and are open for comment ahead of their finalization.
 
Issue 34.1 of Pharmeuropa contains the 48 European Pharmacopoeia texts. Three of the drafts cover the use of edotreotide, gozetotide and oxodotreotide for radiopharmaceutical preparations. Texts about the nuclear medicine procedure positron emission tomography also feature in the issue, with two of the draft documents addressing gallium DOTANOC injection and gallium oxodotreotide injection.
 
Elsewhere, natural products feature heavily. Burdock root, horse-chestnut bark, milk thistle fruit and oak bark are among the revised drafts released for consultation. Once finalized and adopted by the Ph. Eur. Commission, the monographs will become legally binding standards in all member states, leading EDQM to stress that it is “extremely important” for affected organizations to share their views.
 
The drafts are open for comment until 31 March.
 
EDQM Notice
 
MHRA updates medical device guidelines as new requirements take effect
 
MHRA has updated its guidance on the regulation and registration of medical devices in the UK to bring the documents in line with changes that took effect at the start of 2022.
 
The agency originally published the documents at the end of 2020, when the UK was days away from the end of the transition period that had softened the impact of Brexit until that point. As such, the original texts feature advice that is now out of date, such as requests to register devices on the market in Great Britain by certain deadlines in 2021, depending on their risk classification.
 
With some, but not all, of the transition requirements now obsolete, MHRA has updated the documents to reflect the current situation. For example, on 1 January MHRA suspended the accounts of any former Great Britain-based Authorised Representatives who failed to update their role to UK Responsible Person on its registration system by the deadline.
 
Other changes include the removal of a section titled “review registration,” which was only published in September, from the guidance on how to register medical devices with MHRA for sale in Great Britain and Northern Ireland.
 
MHRA Guidance, More
 
Danish regulator clarifies warning statement practices to address uncertainty
 
The Danish Medicines Agency (DKMA) has clarified labeling practices for warning statements on human medicines. DKMA made the clarification after noting uncertainty about practices during its reviews of marketing authorization applications and variations.
 
As DKMA explains, “Schedule 2 of the Danish executive order on labeling lists the warning statements relating to the use of medicines that must be applied to the packaging and included in the package leaflets of human medicines.”
 
The executive order also requires labeling information and package leaflets to be consistent with the authorized Summary of Product Characteristics (SPC). The warning statements provided in schedule 2 are only needed if they are supported by information in the SPC. DKMA uses the SPC to determine if a warning statement is needed when reviewing applications and variations.
 
The clarification covers the timing of revisions to the packaging of medicinal products that are already on the Danish market and special warnings about overdoses and home storage of painkillers containing paracetamol and acetylsalicylic acid. DKMA plans to update its guideline on the executive order to reflect the clarification of labeling practices.
 
DKMA Notice
 
France’s ANSM moves to simplify the set up of clinical trials involving GMOs
 
The French National Agency for Medicines and Health Products Safety (ANSM) is simplifying the set up of clinical trials of drugs and vaccines that contain genetically modified organisms (GMOs).
 
As of 1 January, the responsibility for declaring the use of a GMO that poses zero or negligible risk falls on the sponsor, rather than on the individual sites involved in the clinical trial. The sponsor will make a single declaration for the trial and mention all the sites involved.
 
Currently, sponsors must send the declaration to the Ministry of Higher Education, Research and Innovation (MESRI). That will change on 1 June, when sponsors will be able to send declarations to ANSM. The regulator is yet to share details of how the submission process will work. MESRI and ANSM can refer declarations to expert committees on GMOs.
 
The changes relate to reforms to the law on the procedure for GMOs that pose zero or negligible risk. The new law took effect on 1 January and imposed different requirements depending on whether a GMO has a contained use or is deliberately released into the wider environment.
 
ANSM Notice (French)
 
UK approves Pfizer’s oral antiviral for use against mild-to-moderate COVID-19
 
MHRA has granted conditional marketing authorization to Pfizer’s oral antiviral Paxlovid for use in patients with mild-to-moderate COVID-19 who are at high risk of developing severe disease.
 
The authorization covers the use of Paxlovid in patients who have at least one risk factor for severe COVID-19, such as obesity, older age, diabetes mellitus or heart disease. The UK is making Paxlovid available through 70 new hospital clinics that will send the antiviral to the homes of patients who meet the criteria for the use of the medicine.
 
MHRA’s authorization covers the use of Paxlovid in England, Scotland and Wales, which are known collectively as Great Britain, but not in Northern Ireland. A separate emergency use authorization has been granted for Northern Ireland to ensure Paxlovid is available throughout the UK. Brexit has previously resulted in a treatment being available in Great Britain but not in Northern Ireland.
 
MHRA Notice
 
Other News:
 
Germany’s TÜV Nord Cert GmbH became the 26^th notified body certified under the EU Medical Devices Regulation in late December.
 
The Swiss Agency for Therapeutic Products (Swissmedic) has simplified the procedure for granting temporary authorizations of products that lack the evidence to support a conventional approval. As of 1 January, Swissmedic can grant a temporary authorization in a single step that both rejects the request for an ordinary approval and grants the temporary clearance. Swissmedic Notice