Euro Roundup: Switzerland, too, extends medical device certifications to safeguard supply

Switzerland plans to extend the certification of medical devices to match changes in the EU and reduce the risk of supply disruption.

Recently, the EU changed the timeline for the transition to the Medical Device Regulation in response to a shortfall of notified body capacity that threatened to disrupt supply. Switzerland has aligned its medical device regulations with the EU since 2001 and while companies lost barrier-free access to the market in 2021, the country has continued to try to maintain equivalence with the rules in place (RELATED: Euro Roundup: Switzerland moves to mitigate split from EU on device regulation, Regulatory Focus, 03 June 2021).

The Swiss Federal Council intends to incorporate the EU changes by updating the Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO) in the autumn, according to a statement. Through the updates, Switzerland will maintain equivalence with the EU provisions and “reduce the potential impact on supply” in the country.

The timing means there will be a period in which the situation is different in Switzerland than in the EU but enforcement discretion should prevent disruption. Until MedDO and IvDO are changed, the Swiss Agency for Therapeutic Products (Swissmedic) will “tolerate the placement of devices on the market in Switzerland” that are covered by valid EU certificates.

The approach will prevent “discrepancies in market supply conditions between Switzerland and the EU” and ensure “legal compliance during the transitional phase,” Swissmedic noted. Devices that are marketed in the EU will continue to be eligible for sale in Switzerland. The changes mean the issuing of confirmation letters, as described in an EU position paper, is now unnecessary in Switzerland.

Swissmedic Notice, More

EMA releases draft Q&A on replacing hydrofluorocarbons in metered dose inhalers

The European Medicines Agency (EMA) is seeking feedback on its advice for companies that want to replace hydrofluorocarbons (HFCs) as propellants in oral pressurized metered dose inhalers (pMDIs).

Concern about the environmental impact of HFCs has led the European Commission to start an initiative intended to phase out their use in pMDIs. Some companies have independently started working to change propellants and have sought scientific advice from EMA. The agency has drafted a question-and-answer document in response.

The document focuses on the data requirements for replacing HFCs. EMA begins with general principles, explaining that the data requirements depend on whether the propellant is novel or not. If a company is using a propellant that is not in an approved medicinal product with the same route of administration, it will need to meet requirements on the local tolerance and clinical safety of novel excipients.

Companies should generate data on the effect of the propellant, in the absence of the active ingredient, on ciliary function and airway sensitivity reactions. Because there is no established and validated method for generating ciliary function data, “a thorough justification for the choice of the design is needed.” Companies should collect sensitivity data in patients with asthma.

To satisfy EMA’s concerns, companies should run at least one study that collects adverse events such as bronchoconstriction, hoarseness and cough. EMA wants the studies to collect data for at least three months and said 300 subjects per treatment arm “would allow an adequate estimation of common adverse events.”

EMA is accepting feedback until 31 May.

Draft Q&A

EMA shares advice on managing clinical trials affected by wars and natural disasters

EMA’s Good Clinical Practice Inspectors Working Group (GCP IWG) has published advice on managing ongoing clinical trials that are affected by political conflicts, natural disasters or other major disruptions. The document draws on the experience of EMA and sponsors during the COVID-19 pandemic and the war in Ukraine.

EMA is advising sponsors to take a risk-based approach, factoring in potential loss of data and ethical impacts, when considering whether to adjust the conduct of clinical trials in response to disruption. The sponsor should assess each ongoing trial and the risk of each study participant.

Potential responses included the introduction of decentralized elements, such as video calls rather than in-person visits, temporary halts on activity at some sites, the extension of the duration of the study and changes to where lab tests are performed. Monitoring always remains a requirement but can be performed remotely “depending on its purpose and suitability.”

The document also covers the transfer of clinical trial participants to other sites, both within the same country and to another part of the European Economic Area. If a participant is moved to a country where the clinical trial is not authorized, the sponsor should contact the national competent authority to clarify the local law and determine the options for the continued treatment of the patient.

EMA Advice

J&J receives EMA letter of support for pulmonary hypertension PRO symptom scale

Johnson & Johnson has received an EMA letter of support for the development of a patient-reported outcome (PRO) instrument for use in pulmonary hypertension clinical trials.

The instrument, PAH-SYMPACT, assesses changes in the presence and severity of symptoms and how they affect the physical, emotional and cognitive functioning of adult patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) over time. J&J created the instrument for PAH but the overlap with symptoms of CTEPH led it to expand its research.

In 2021, J&J requested qualification advice on the instrument. After meeting with the company last year, EMA issued a letter of support last week to encourage further validation work and the use of the PRO instrument in PAH and CTEPH clinical trials. EMA’s executive director Emer Cooke wrote the letter after determining that the validation strategy is reasonable and the information provided is “promising.”

“Focus on frequently reported items subject to change was considered appropriate in the context of a PRO instrument designed to capture the effect of treatment on symptoms and impacts,” Cooke wrote. “Provided additional supportive analyses are presented, PRO endpoints reflective of the symptom and impact domains of the PAH-SYMPACT can be considered for regulatory decisions.”

EMA Letter

Other news:

EMA has updated its guideline on influenza vaccine submission and procedural requirements. The changes affect an annex on the product information requirements. EMA has restructured a table that sets out the information that should be included in the package leaflet and other aspects of the labeling, and updated its examples of the influenza strains that may be referenced. EMA Guideline

EMA has increased its regulatory fees by 10.4% to account for inflation. The changes, which took effect on 1 April, also extend the scope of the fee exemptions for preparedness against biological agents that may be used as weapons of bioterrorism to cover all medicinal products authorized under exceptional circumstances, not just vaccines. EMA Notice

Euro Roundup: Switzerland, too, extends medical device certifications to safeguard supply

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