Euro Roundup: Swissmedic updates guidance on combined clinical trials to test drugs, devices

The Swiss Agency for Therapeutic Products (Swissmedic) has updated its guidance on running clinical trials that test multiple types of products such as medical devices and medicinal products.

Swissmedic previously provided information on running combined trials in two documents, one focused on clinical investigations with medical devices, and another that covers performance studies with in vitro diagnostics (IVD). The Swiss regulatory agency updated the combined trial annex in both documents last week. Each document provides slightly different information.

In the IVD text, Swissmedic explains that sponsors must meet the requirements for clinical trials with medicinal products or advanced therapy medicinal products (ATMPs), plus the rules for interventional performance studies with IVDs. The agency points to a Medical Device Coordination Group Document document on the interface between the European Union regulations on IVDs and clinical trials for additional information.

Swissmedic accepts combined IVD trials that are described in one protocol for all the tested products, as well as studies that are split into two or more subprotocols. Different sponsors can handle the medicinal product and IVD subprotocols.

“As the products will influence the safety and/or efficacy of the same treatment in the same patient, Swissmedic will carry out coordinated reviews. During an approved trial, Swissmedic accepts reports of both sponsors,” the agency wrote in the guidance.

Swissmedic describes four ways to submit clinical trial applications depending on whether the IVD and medicinal product are, respectively, CE marked and authorized by Swissmedic in the study population. No submission is needed if both products are already on the market and being studied per their labels. A separate submission route is used for studies of ATMPs and medical devices.

The medical device guidance features a similar table setting out the four application routes. The texts differ in some areas, though, including a table on submitting amendments for clinical trials that were previously approved by Swissmedic. Both documents tell sponsors that they need to update the clinical investigation plan, but the medical device guidance features additional information.

“Make sure that in your project the [(serious) adverse event] and device deficiencies are also fully captured according to medical device requirements. Please note that these requirements are more stringent than requirements for medicinal product trials. Notably, more SAE need to be captured and additional information are required,” Swissmedic wrote in the medical device guidance.

The medical device guidance also features a section on combination products. In the section, Swissmedic links to documents that explain how it handles borderline issues with drug-device combination products and lists several examples that explain, for example, that a drug-eluting coronary stent is considered a medical device.

Swissmedic used the update to make other changes to the IVD guidance. The latest version features an updated decision tree for authorization applications and EU common specifications for certain class D IVDs.

Swissmedic Notice

France’s ANSM takes legal action against Philips over failure to hit respiratory recall targets

The French National Agency for the Safety of Medicines and Health Products (ANSM) is taking legal action against Philips in relation to the progress of its recall of sleep and respiratory medical devices.

In February 2022, ANSM gave Philips until the end of the year to replace all its defective ventilation devices. As of the end of last month, the Dutch medtech company had manufactured and shipped 99% of the continuous positive airway pressure (CPAP) devices and 78% of the non-life support ventilators intended to replace its defective devices.

However, according to ANSM, Philips had only shipped 8% of the life support ventilators to home care providers. ANSM said the care providers have switched to devices from other manufacturers and posted estimates of the extent of the loss of market share. Philips competes with ResMed for the CPAP market.

Because Philips failed to meet the targets ANSM set last year, the French regulator has contacted the public prosecutor. ANSM is pursuing legal action while continuing to push Philips to complete the recall and replacement process. The prospect of potentially permanently losing market share means Philips is already strongly incentivized to move quickly but repairing or replacing millions of devices globally has taken time.

ANSM Notice (French)

Time to first MHRA opinion on UK clinical trial filings increases for 9th month in a row

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has reported another increase in the average time to deliver initial review letters for Phase 1-4 clinical trials in patients.

In March, the average time from the receipt of a valid clinical trial application for studies in patients, as opposed to healthy volunteers, to the issuance of an initial opinion letter exceeded 80 calendar days. The wait in March was considerably longer than at any other time over the past year.

In June 2022, the average wait was around 30 calendar days. Since then, the average time to an initial opinion letter has increased each month, passing 70 calendar days in February and 80 calendar days in March. The figures released by MHRA lack an explanation for the trend.

MHRA shared the data alongside other figures on its clinical trial application review process. The number of applications assessed increased in March for the first time since July. From July 2022 to February 2023, the number of first opinion letters issued by MHRA fell from 74 to 30, before jumping up to 49 in March.

MHRA Report, More

ANSM creates platform to access data on adverse reactions, medication errors and shortages

ANSM has created an online platform for viewing data on adverse drug reactions, medication errors and drug shortages. The database goes back to 2014 and is aimed at everyone from the public to drug manufacturers.

ANSM developed the portal, called data.ansm, in partnership with the Health Data Hub, a government initiative designed to make data available to researchers. The Hub selected data.ansm as one of 10 pilot projects in 2019 and supported the processing of the data. ANSM will update the data every April.

The portal brings together data from five repositories, including ANSM's national pharmacovigilance database, repository of information on marketing authorizations for medicinal products and database of medication errors. Searching for a drug product in the database brings up information about how widely it is used, the number and type of adverse reactions and a list of supply disruptions and their causes.

ANSM Notice (French)

Denmark’s DKMA extends temporary policy for critical antibiotics

The Danish Medicines Agency (DKMA) has extended a temporary policy it adopted in January to protect the supply of 10 critical antibiotics as supply remains disrupted.

In January, the European Medicines Agency called on national regulatory bodies to take steps to ensure the local supply of antibiotics amid region-wide shortages.

The extension reflects both general supply difficulties in the EU and specific challenges in Denmark, according to DKMA. Sandoz recalled Dicillin Sandoz 500 mg capsules from the Danish market in February in response to the discovery of multi-resistant bacteria that “may originate from the medicine.”

DKMA Notice (Danish)

Euro Roundup: Swissmedic updates guidance on combined clinical trials to test drugs, devices

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