Euro Roundup: Swissmedic requests prior notification of new active substance applications

The Swiss Agency for Therapeutic Products (Swissmedic) is asking companies to give it 4-6 months’ notice before they submit applications for approval of new active substances.

Swissmedic wants drug developers to use the eGov portal to provide prior notification. The notifications should include an approximate submission date, plus or minus two weeks, and information such as the active substance, product name, indication and pharmaceutical form. Swissmedic wants companies to let it know if their planned submission date changes.

Once Swissmedic receives a notification, it will start “preliminary resource planning, enter a dummy application in the internal planning system and assign this an application identifier,” the agency said. Applicants will be able to see the application ID in the eGov portal and must provide it as a reference in the subsequent submission.

The process, which is now live, is intended to enable Swissmedic to “plan resources early on and subsequently supports efficient processing of applications.” Receiving prior notification “is an advantage” for all new active substance filings, Swissmedic said, including accelerated, simplified and international procedures.

The voluntary process is part of a wider push by regulators to get more visibility into upcoming applications. The European Medicines Agency (EMA) discussed the “very poor predictability” of initial marketing authorization applications at industry platform meetings in 2021, 2022 and 2023.

An EMA focus group began actively monitoring upcoming applications last year, starting by contacting companies to confirm they were still planning a submission. While the goal was to “deter multiple changes” to the submission date, the approach failed to have the desired impact, with EMA concluding that “active monitoring seems not to have had any effect on submission predictability.”

Swissmedic Notice

Commission tracks 35% increase in MDR applications, reduction in missing documents

The number of applications for certification under the Medical Device Regulation (MDR) increased 35% between June and October last year, according to survey data collected by the European Commission.

In the October survey, notified bodies disclosed 17,846 MDR submissions, up from 13,177 four months earlier. The increase was accompanied by a 43% jump in MDR certificates, which climbed from 3,899 to 5,599 over the analyzed period. An analysis performed in April 2022 found there were just over 25,000 certificates issued under the various annexes of the old device directives.

The Commission shared updated application and certificate figures along with other data it is collecting from notified bodies. In October, the proportion of submissions with a completeness rate of more than 50% rose to 26%, up from 13% in March and 21% in June. Despite the gains, the Commission said, “incomplete submissions remain high.” Notified bodies refused 124 incomplete filings in the latest poll.

Incomplete submissions hinder the transition to MDR. More than two thirds of notified bodies said that less than 25% of their clients have completed the transfer of all devices intended to be certificated under MDR.

The Commission also presented data on the In Vitro Diagnostic Regulation (IVDR). The number of IVDR applications and certificates rose 30% and 40%, respectively, from June to October. The number of filings and certificates for Class D devices, the products with the near-term deadline that informed plans to extend the timeline, hit 336 and 119, respectively, in October.

Survey Results

Medtech groups call for MDCG to prioritize work on electronic instructions

MedTech Europe and other groups have called for the Medical Device Coordination Group (MDCG) to prioritize work on electronic instructions for use to expand the scope for specific product categories.

In December 2021, the European Union published an implementing regulation to set the conditions for providing instructions for use in electronic form. However, a coalition of organizations are concerned that the regulation’s “scope is limited to specific categories of devices” and it “no longer reflects the generally acknowledged state of the art.”

MedTech Europe and 11 aligned organizations are calling for “a targeted update to the scope” of the regulation to “encourage a level playing field.” The request is supported by survey data that shows a preference for electronic materials among healthcare professionals, hospital administrative staff and pharmacists.

MedTech Europe shared more details of its position in a paper published in November. The paper makes the case for the extension of the European legislation to include all professional-use medical devices. The trade group framed the extension as aligning the EU with other major markets that adopted electronic instructions “without an increase in vigilance cases.”

Joint Statement

MDCG lays out procedures for annual and ad-hoc revisions of device nomenclature

MDCG has created procedures for the annual and ad-hoc revision of the resource created to ensure the consistent, structured naming of medical devices.

To support MDR and IVDR, the EU has created the European Medical Device Nomenclature (EMDN). The resource is intended to help manufacturers register devices in the EUDAMED database and play a role in other MDR and IVDR documents. Officials will update EMDN annually based on practical use of the resource and feedback from users.

MDCG’s guidance establishes procedures for the annual revision, as well as a process for ad-hoc requests requiring an expedited review. Each February, the European Medical Device Nomenclature Technical Team (EMDN-TT) will start reviewing requests submitted by users up to the end of January, as well as requests from the nomenclature working group.

EMDN-TT will publish a draft proposal for review by the working group. The goal is to get the final text endorsed by MDCG and published as an official update in EUDAMED in November or December.

Generally, officials will review requests for changes annually but competent authorities and notified bodies can ask for ad-hoc changes. Applicants must show why the request should be assessed under the ad-hoc procedure and provide a detailed description of the device.

MDCG Guidance

MHRA withdraws advice to avoid repeated exposure to paclitaxel-coated devices

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has withdrawn advice to avoid repeated exposure to paclitaxel-coated devices in response to new long-term data.

MHRA, like other regulatory agencies, began assessing the safety of the products after a meta-analysis of randomized controlled trials linked them to an increased risk of death in 2018. The next year, the agency published a report from independent expert advisors. MHRA has continued to update its position as new data has emerged, most recently in April 2022.

Now, the agency has revised its position again, this time in response to long-term data published late last year and the advice of the Interim Devices Working Group. The group advised MHRA that “the new studies did not support a statistically significant increased risk of harm” with the devices in peripheral arterial disease (PAD) “irrespective of disease type, severity, or another associated variable.”

Supported by that conclusion, the group advised MHRA to withdraw its previous advice to use the lowest dose of paclitaxel and avoid or reduce repeated exposure to devices coated with the drug. MHRA acted on the advice and is now telling healthcare professionals that the devices can be considered in PAD.

MHRA Notice

Other news:

MHRA has designated two new UK Approved Bodies. The organizations, LNE-GMED UK and Scarlet NB UK, join seven other bodies that were previously cleared to certify medical devices in the UK. MHRA Notice

Euro Roundup: Swissmedic requests prior notification of new active substance applications

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