Euro Roundup: Commission posts guide to validity of studies for joint clinical assessments

The European Commission has published guidance on the validity of studies for joint clinical assessments (JCA) under the EU Health Technology Assessment Regulation (HTAR).

Assessing and describing the certainty of study results in an objective, reproducible and transparent way is part of the HTA process. JCAs entail assessing “the degree of certainty of the relative effects, taking into account the strengths and limitations of the available evidence.” However, elements that inform the certainty depend on the context.

HTAR states the JCA report “should be factual and should not contain any value judgment.” Assessments of the certainty of study results must remain descriptive at the European level and avoid conclusions that may interfere with independent decision-making at the national level.

“Methodological systems that entail not only assessment, but also appraisal, cannot (or only partially) be applied in European HTA, since appraisal includes value judgment and (pre-)determines a decision on pricing and reimbursement of a health technology,” the guidance states. Yet, valid scientific principles are still required to guide JCA development and ensure results are understandable at a national level.

The guidance is intended to further that aim by defining, classifying and assessing the certainty of results of studies in an objective, reproducible and transparent way “leading to the statistical analysis of data considered as originating from or part of a single study (i.e., one sample of patients),” the document states.

The document, which was adopted by the Coordination Group on Health Technology Assessment, sets out general considerations, looks at different study designs and their specific strengths and weaknesses, and addresses “particularities” such as master protocols and registries.

Commission Guidance, More

EMA answers questions about fluorinated greenhouse gasses in metered dose inhalers

The European Medicines Agency (EMA) has published a question-and-answer document about the labeling requirements for metered dose inhalers containing fluorinated greenhouse gasses.

EMA’s Quality Review of Documents (QRD) group published the document in response to the European Commission’s policy on fluorinated greenhouse gasses and its legal framework and implementation acts. The legal framework requires metered dose inhalers containing fluorinated greenhouse gasses, such as hydrofluorocarbons, to comply with new labeling requirements from 1 January 2025.

QRD published the text companies need to include on the outer packaging or immediate packaging and in the package leaflet in a separate document. The Q&A adds details, such as the requirement for the font size to “not be smaller than the minimum size of other information on the immediate packaging or outer carton.”

Companies seeking marketing authorizations that expect to receive an EMA opinion after 1 January need to comply with the new legal requirements and include the relevant standard statements in the product information. Companies with affected authorized metered dose inhalers with ongoing variations should add the wording as part of the ongoing procedure.

“The new labeling requirements laid down in the Article 12 should apply from 1 January 2025. MAHs of metered dose inhalers containing fluorinated greenhouse gasses must initiate the relevant processes to comply with the new requirements as soon as possible,” EMA said.

EMA Notice

MDCG updates Q&A on transitional provisions for certification of class D diagnostics

The Medical Device Coordination Group (MDCG) has updated a document on the transitional provisions for certification of class D in vitro diagnostics (IVD), adding a new question and revising its answers to several existing queries.

MDCG’s new question asks what the 1 October date of application of the designation of EU reference laboratories (EURL) means in practical terms for tasks performed by labs such as sample or batch testing.

“In particular for batch testing, as of 1 October 2024, for all class D devices for which notified bodies have issued a certificate under the IVDR, and which fall within a scope of a designated EURL, notified bodies are obliged to contact an appropriate EURL and engage in the activities described in Articles 10, 11 and 13 of Commission Implementing Regulation (EU) 2022/944,” MDCG said.

MDCG said notified bodies should engage with an appropriate EURL for batch testing before issuing certificates for all class D devices that they are assessing for conformity under the IVD regulation.

MDCG Guide

ABPI updates pharma code of practice with new PMCPA constitution and procedure

The Association of the British Pharmaceutical Industry (ABPI) has published an updated Code of Practice for the industry.

As part of the update, ABPI has created a new constitution and procedure for the Prescription Medicines Code of Practice Authority (PMCPA), the organization that independently administers the code. ABPI said the update includes an abridged procedure for complaints that meet certain criteria.

“The abridged complaints procedure will allow the PMCPA the flexibility to continue to assess more serious complaints in full but deal with less serious complaints in a proportionate and resource-efficient manner,” ABPI said.

Other changes include the addition of text to “strengthen the operational independence of the PMCPA in line with the regulatory principle of transparency and the public law principles of procedural fairness and lack of bias,” ABPI said. The revised code also updates how prescribing information can be provided and makes it mandatory for companies to submit links to their disclosure information to a public database.

ABPI Notice

SwissGMDP database goes live, giving public access to Swiss good practice certificates

The Swiss Agency for Therapeutic Products (Swissmedic) has launched a database that gives the public access to good manufacturing and distribution practice (GMP/GDP) certificates from all authorized Swiss pharmaceutical companies.

Swissmedic’s database, which is called SwissGMDP, lists all valid establishment license holders and their locations. Visitors can access the license holders’ electronic GMP and GDP certificates. Swissmedic said the database will enable stakeholders to “quickly and easily check the validity and scope of an operating license, including sites, licensed activities and GMP or GDP status.”

The database replaces a table of establishment license holders that Swissmedic published on its website. Users can create Excel lists based on specific search criteria or for all sites. Launching SwissGMDP is part of an attempt to improve the exchange of information between authorities, industry and the public.

Swissmedic Notice

MHRA starts accepting applications for AI Airlock regulatory sandbox pilot

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has begun accepting applications to join the AI Airlock regulatory sandbox for medical device developers.

Through the pilot project, MHRA is aiming to identify and address challenges for regulating AI medical devices. The regulator believes the insights could help cut the time it takes to make safe AI devices available to patients.

Participants in the pilot will “benefit from a bespoke testing plan,” MHRA said, and work with regulatory experts to understand the current framework and expected data standards. To join the program, applicants must show their AI-powered medical device has the potential to deliver benefits to patients, is a novel or innovative application and can present a regulatory challenge suitable for the Airlock pilot.

MHRA is accepting applications until 7 October. The agency wants to recruit candidates that cover a wide range of regulatory challenges, “from different healthcare or clinical disciplines and at various stages of product and regulatory development.”

MHRA Notice, More

Euro Roundup: Commission posts guide to validity of studies for joint clinical assessments

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